Eli Lilly and Company was given the President's Award by the National Hispanic Council on Aging (NHCOA) at its annual conference in Washington, D.C.
Lilly has developed a successful partnership with the NHCOA to address specific issues facing the aging Hispanic community, such as disparities that exist in the diagnosis of chronic disease.
"The National Hispanic Council on Aging's leadership is proud to honor Lilly with the 2010 President's Award, recognizing the company's commitment to improving the wellbeing of its target audience - especially older adults," said Dr. Yanira Cruz, president & CEO of the NHCOA. "Lilly's philanthropic commitment should serve as an example in the pharmaceutical industry. We applaud Lilly's innovation in addressing key health issues impacting older adults such as diabetes, mental health and Alzheimer's disease."
As part of Lilly's commitment to overcoming health disparities, the company is working to increase Hispanic representation in clinical trials. In the United States, minority populations have historically and consistently been under-represented in clinical trials, which evaluate the safety and efficacy of new medicines and treatments. As part of Lilly's clinical diversity strategy, Lilly is identifying and investing in new relationships with clinical investigators who are likely to treat more diverse patients. As a result, more than 83 new clinical trial sites have been introduced in communities of color since May 2008.
Currently, Lilly and NHCOA are working together to develop initiatives designed to promote diabetes prevention and improve diabetes management among Hispanic older adults and their families through the development of culturally--and linguistically--appropriate and age-sensitive educational efforts. This program aims to reduce the significant disparities that exist between Hispanic and non-Hispanic adults in the United States.
"Lilly and the Council both see the value of promoting better health for our older citizens, and we're pleased that our work has been recognized with this award," said Shaun Hawkins, chief diversity officer at Lilly. "Our commitment to engage, educate and empower patients to take control of their own health becomes even more important when we are working with populations that do not have access to the resources they need to become healthier. Our partnership with NHCOA helps make that connection for patients."
Additional outreach initiatives are conducted by the Organization of Latinos at Lilly, or OLA, an internal employee group. OLA diversity initiatives impact the community, the company and its members by actively supporting the Hispanic/Latino community. For example, OLA members participate in Project Stepping Stone, a community event for Latino high school students from Indiana who are interested in attending college. OLA members also contribute annually to the Hispanic Scholarship Fund organized by USA Funds to help Latino youth access and afford a college education.
Monday, October 4, 2010
GSK provides update on Herpevac trial for women evaluating Simplirix™ (Herpes Simplex Vaccine)
GlaxoSmithKline (GSK) has made the decision not to pursue further worldwide development of Simplirix™ (Herpes Simplex Vaccine), an experimental vaccine intended to prevent genital herpes disease in women.
The decision was made following receipt of the results of the Herpevac Trial for Women, a Phase III trial evaluating efficacy of Simplirix™, which was conducted collaboratively with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada. An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.
Gary Dubin, Vice President and Director, Late Clinical Development at GlaxoSmithKline Biologicals commented: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the program and the volunteers for their participation in the study.”
The decision was made following receipt of the results of the Herpevac Trial for Women, a Phase III trial evaluating efficacy of Simplirix™, which was conducted collaboratively with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).
The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada. An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.
Gary Dubin, Vice President and Director, Late Clinical Development at GlaxoSmithKline Biologicals commented: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the program and the volunteers for their participation in the study.”
Sunday, September 26, 2010
Adding Lantus® to Oral Antidiabetic Drug Therapy Further Reduced Blood Sugar in Patients with Type 2 Diabetes.
Sanofi-aventis announced
results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th
Annual Meeting in Stockholm, Sweden. The first pooled analysis using patient-level data from randomized
clinical trials demonstrated that adding Lantus® (insulin glargine [rDNA] injection) to patients with type 2
diabetes, uncontrolled on oral antidiabetic drug therapy (OADs), was associated with a greater reduction in
A1C levels and lower incidence of any hypoglycemia versus all comparators (OADs, NPH, lispro, premix).
In the second pooled analysis of clinical studies, “patients with type 2 diabetes, who used Lantus® as
monotherapy or added it to one baseline oral antidiabetic agent, demonstrated a greater reduction in A1C
with lower risk of hypoglycemia than those taking two OADs, with a most significant reduction when Lantus®
was added to metformin alone versus other OADs [sulfonylurea alone or sulfonylurea plus metformin],” said
Dr. Jack Leahy of the University of Vermont College of Medicine and principal investigator of one of the
studies.
Better Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus All Comparatorsi
“Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus Competitors” [presentation number
976]: This pooled analysis looked at nine clinical studies where insulin-naïve patients with type 2 diabetes
uncontrolled on OADs were randomized to add Lantus® (n=1,462) or comparators (OADs, NPH, lispro or
premix; n=1,476) to their treatment regimen. Results showed that initiating Lantus® in patients uncontrolled
on OADs was associated with better efficacy and goal attainment overall versus all comparators across the
A1C continuum and when compared to OADs when baseline A1C was ≥8.0 percent.
Outcomes showed:
A1C reductions at week 24 were greater with Lantus® versus all comparators (p<0.001)
Efficacy across A1C categories were similar for insulin comparators
Hypoglycemia rates (any) were lower with Lantus® versus other insulin comparators (Lantus® vs.
NPH, p=0.032, Lantus® vs. lispro, p=<0.001, Lantus® vs. premix, p=004)
Hypoglycemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of
severe hypoglycemia were similar between the two groups.
2 / 4
Significant Improvement in A1C Found Independent of Baseline Treatment Regimenii
“Clinical Outcomes after Basal Insulin Initiation Correlate with Baseline Oral Antidiabetic Drug Therapy: A
Pooled Analysis of Clinical Trial Data” [presentation number 960]: This analysis included data from 11
prospective randomized controlled trials of Lantus® with or without OADs in adults with type 2 diabetes. The
analysis compared patients given Lantus® (n=2,171) who were taking zero or one OAD at baseline (low use;
1.8% and 45.2%, respectively) with those taking two OADs (52.2%) and patients on metformin only (8.5%)
with those on sulfonylurea only (36.5%) or metformin and sulfonylurea (49.9%) at baseline.
Outcomes showed:
At week 24, the reduction in A1C was greatest among patients given Lantus® with low baseline OAD
use (0/1 OADs) (p=0.0198) and among those who were taking Lantus® and metformin only
(p=0.0009)
Patients given Lantus® with low baseline OAD use had significantly lower rates of symptomatic
hypoglycemia versus those taking two OADs (p=0.0009)
Patients given Lantus® who were taking only metformin had lower rates of hypoglycemia than those
taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus
37.5 versus 38.8 U)
Important Safety Information for Lantus®
Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to
your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision.
Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may
lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include injection site reactions,
including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare
cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and
supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell
your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or
planning to become pregnant, or are breast-feeding or planning to breast-feed.
Indications and Usage
Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children
(6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at
the same time each day to lower blood glucose. Do not use Lantus® to treat diabetic ketoacidosis.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Lantus®, please visit www.Lantus.com or call 800-633-1610.
Important Safety Information for Apidra®
Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the
ingredients in Apidra®.
You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your
dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others. Apidra®,
when given by injection under the skin, should not be mixed with insulins other than NPH.
3 / 4
Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.
The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include low blood potassium,
injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as
itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to
insulin, including anaphylactic reactions.
Tell your doctor about other medicines and supplements you are taking because they can change the way
insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have
liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to
breast-feed.
Indications and Usage
Prescription Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1
diabetes to improve blood sugar control. Apidra® is usually used with a longer-acting insulin. When used as a
mealtime insulin, Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal.
Apidra® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Apidra®, please visit www.Apidra.com or call 800-633-1610.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the
hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is
estimated that approximately 285 million adults worldwide are living with the disease and this number is
expected to rise to a staggering 438 million within 20 yearsiii,iv. It is estimated that nearly 24 million Americans
have diabetes, including an estimated 5.7 million who remain undiagnosedv At the same time, according to
NHANES data from 2003-2004, approximately 40 percent of those diagnosed with diabetes did not achieve
the blood sugar control target of A1C <7 percent recommended by the ADAvi. The A1C test measures
average blood glucose levels over the past two-to-three-month period.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people
living with diabetes. The Company currently has insulin products, including Lantus®, Apidra® and Insuman®
(outside the U.S.)-- Lantus® and Apidra® are also available as injection pens (Lantus® SoloSTAR® and
Apidra® SoloSTAR®). Also available in some countries (outside the U.S.) is ClikSTAR®, a reusable insulin
injection pen for Lantus® or Apidra® for people with type 1 or type 2 diabetes. Following the formation of its
Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood
glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational
compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide as a
monotherapy and in combination with basal insulin as well as long-acting insulin analogs.
results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th
Annual Meeting in Stockholm, Sweden. The first pooled analysis using patient-level data from randomized
clinical trials demonstrated that adding Lantus® (insulin glargine [rDNA] injection) to patients with type 2
diabetes, uncontrolled on oral antidiabetic drug therapy (OADs), was associated with a greater reduction in
A1C levels and lower incidence of any hypoglycemia versus all comparators (OADs, NPH, lispro, premix).
In the second pooled analysis of clinical studies, “patients with type 2 diabetes, who used Lantus® as
monotherapy or added it to one baseline oral antidiabetic agent, demonstrated a greater reduction in A1C
with lower risk of hypoglycemia than those taking two OADs, with a most significant reduction when Lantus®
was added to metformin alone versus other OADs [sulfonylurea alone or sulfonylurea plus metformin],” said
Dr. Jack Leahy of the University of Vermont College of Medicine and principal investigator of one of the
studies.
Better Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus All Comparatorsi
“Efficacy and Goal Attainment Demonstrated with Insulin Glargine versus Competitors” [presentation number
976]: This pooled analysis looked at nine clinical studies where insulin-naïve patients with type 2 diabetes
uncontrolled on OADs were randomized to add Lantus® (n=1,462) or comparators (OADs, NPH, lispro or
premix; n=1,476) to their treatment regimen. Results showed that initiating Lantus® in patients uncontrolled
on OADs was associated with better efficacy and goal attainment overall versus all comparators across the
A1C continuum and when compared to OADs when baseline A1C was ≥8.0 percent.
Outcomes showed:
A1C reductions at week 24 were greater with Lantus® versus all comparators (p<0.001)
Efficacy across A1C categories were similar for insulin comparators
Hypoglycemia rates (any) were lower with Lantus® versus other insulin comparators (Lantus® vs.
NPH, p=0.032, Lantus® vs. lispro, p=<0.001, Lantus® vs. premix, p=004)
Hypoglycemic event rates (any) were higher for Lantus versus OADs (p<0.001), although rates of
severe hypoglycemia were similar between the two groups.
2 / 4
Significant Improvement in A1C Found Independent of Baseline Treatment Regimenii
“Clinical Outcomes after Basal Insulin Initiation Correlate with Baseline Oral Antidiabetic Drug Therapy: A
Pooled Analysis of Clinical Trial Data” [presentation number 960]: This analysis included data from 11
prospective randomized controlled trials of Lantus® with or without OADs in adults with type 2 diabetes. The
analysis compared patients given Lantus® (n=2,171) who were taking zero or one OAD at baseline (low use;
1.8% and 45.2%, respectively) with those taking two OADs (52.2%) and patients on metformin only (8.5%)
with those on sulfonylurea only (36.5%) or metformin and sulfonylurea (49.9%) at baseline.
Outcomes showed:
At week 24, the reduction in A1C was greatest among patients given Lantus® with low baseline OAD
use (0/1 OADs) (p=0.0198) and among those who were taking Lantus® and metformin only
(p=0.0009)
Patients given Lantus® with low baseline OAD use had significantly lower rates of symptomatic
hypoglycemia versus those taking two OADs (p=0.0009)
Patients given Lantus® who were taking only metformin had lower rates of hypoglycemia than those
taking sulfonylurea or metformin plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus
37.5 versus 38.8 U)
Important Safety Information for Lantus®
Do not take Lantus® if you are allergic to insulin or any of the inactive ingredients in Lantus®.
You must test your blood sugar levels while using insulin, such as Lantus®. Do not make any changes to
your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision.
Do NOT dilute or mix Lantus® with any other insulin or solution. It will not work as intended and you may
lose blood sugar control, which could be serious. Lantus® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
The most common side effect of insulin, including Lantus®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include injection site reactions,
including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare
cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and
supplements you are taking because they can change the way insulin works. Before starting Lantus®, tell
your doctor about all your medical conditions including if you have liver or kidney problems, are pregnant or
planning to become pregnant, or are breast-feeding or planning to breast-feed.
Indications and Usage
Prescription Lantus® is a long-acting insulin used to treat adults with type 2 diabetes and adults and children
(6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at
the same time each day to lower blood glucose. Do not use Lantus® to treat diabetic ketoacidosis.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Lantus®, please visit www.Lantus.com or call 800-633-1610.
Important Safety Information for Apidra®
Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you are allergic to any of the
ingredients in Apidra®.
You must test your blood sugar levels while using insulin, such as Apidra®. Do not make any changes to your
dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Apidra® must only be used if the solution is clear and
colorless with no particles visible. Do not share needles, insulin pens or syringes with others. Apidra®,
when given by injection under the skin, should not be mixed with insulins other than NPH.
3 / 4
Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.
The most common side effect of insulin, including Apidra®, is low blood sugar (hypoglycemia), which
may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and
blurred vision. Severe hypoglycemia can be dangerous and can cause harm to your heart or brain. It may
cause unconsciousness, seizures, or death. Other possible side effects may include low blood potassium,
injection site reactions, such as changes in fat tissue at the injection site, and allergic reactions, such as
itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy to
insulin, including anaphylactic reactions.
Tell your doctor about other medicines and supplements you are taking because they can change the way
insulin works. Before starting Apidra®, tell your doctor about all your medical conditions including if you have
liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to
breast-feed.
Indications and Usage
Prescription Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1
diabetes to improve blood sugar control. Apidra® is usually used with a longer-acting insulin. When used as a
mealtime insulin, Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal.
Apidra® SoloSTAR® is a disposable prefilled insulin pen.
For full prescribing information for Apidra®, please visit www.Apidra.com or call 800-633-1610.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the
hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is
estimated that approximately 285 million adults worldwide are living with the disease and this number is
expected to rise to a staggering 438 million within 20 yearsiii,iv. It is estimated that nearly 24 million Americans
have diabetes, including an estimated 5.7 million who remain undiagnosedv At the same time, according to
NHANES data from 2003-2004, approximately 40 percent of those diagnosed with diabetes did not achieve
the blood sugar control target of A1C <7 percent recommended by the ADAvi. The A1C test measures
average blood glucose levels over the past two-to-three-month period.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people
living with diabetes. The Company currently has insulin products, including Lantus®, Apidra® and Insuman®
(outside the U.S.)-- Lantus® and Apidra® are also available as injection pens (Lantus® SoloSTAR® and
Apidra® SoloSTAR®). Also available in some countries (outside the U.S.) is ClikSTAR®, a reusable insulin
injection pen for Lantus® or Apidra® for people with type 1 or type 2 diabetes. Following the formation of its
Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood
glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational
compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide as a
monotherapy and in combination with basal insulin as well as long-acting insulin analogs.
Clinical Update on TAMARIS Phase III Trial for NV1FGF Paris,
Sanofi-aventis announced that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen
pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of
NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months,
whichever came first, in critical limb ischemia patients who were not eligible for revascularization.
“We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial, and for patients who
are suffering from the dramatic consequences of this disease and are hoping for new treatments” said Marc
Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis. “We are evaluating all
options on the NV1FGF development and remain committed to innovation in diseases where there are major
healthcare needs and no therapeutic alternative”.
The full results of this trial will be presented at the American Heart Association Congress, on November 16,
2010 and are embargoed until this date.
TAMARIS is a randomized, double blind, placebo controlled study designed to evaluate the safety and efficacy
of NV1FGF in patients with critical limb ischemia and skin lesions who are not eligible for revascularization.
The study was conducted in more than 170 sites in 30 countries on five continents and enrolled a total of 525
patients being administered either NV1FGF or placebo intramuscularly every 2 weeks over a 6 week period.
Riferminogen pecaplasmid (NV1FGF) is a non viral plasmid-based gene local delivery system for human
fibroblast growth factor (FGF-1). FGF-1 promotes angiogenesis and induces the formation of new blood
vessels that could improve blood flow of the limbs of CLI patients.
pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of
NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months,
whichever came first, in critical limb ischemia patients who were not eligible for revascularization.
“We are disappointed that NV1FGF failed to achieve significance in the TAMARIS trial, and for patients who
are suffering from the dramatic consequences of this disease and are hoping for new treatments” said Marc
Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis. “We are evaluating all
options on the NV1FGF development and remain committed to innovation in diseases where there are major
healthcare needs and no therapeutic alternative”.
The full results of this trial will be presented at the American Heart Association Congress, on November 16,
2010 and are embargoed until this date.
TAMARIS is a randomized, double blind, placebo controlled study designed to evaluate the safety and efficacy
of NV1FGF in patients with critical limb ischemia and skin lesions who are not eligible for revascularization.
The study was conducted in more than 170 sites in 30 countries on five continents and enrolled a total of 525
patients being administered either NV1FGF or placebo intramuscularly every 2 weeks over a 6 week period.
Riferminogen pecaplasmid (NV1FGF) is a non viral plasmid-based gene local delivery system for human
fibroblast growth factor (FGF-1). FGF-1 promotes angiogenesis and induces the formation of new blood
vessels that could improve blood flow of the limbs of CLI patients.
GSK regulatory update on Avandia following EMA and FDA reviews
GlaxoSmithKline (GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.
Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.
Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent re-adjudication of the endpoints reported in the large, prospective, randomised, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.
In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl®) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.
Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.
Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent re-adjudication of the endpoints reported in the large, prospective, randomised, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).
Eli Lilly and Company Encourages African-Americans to Get a Check-up and Face Diabetes
Angie Stone and Anthony Anderson, spokespeople for Lilly's Fearless African-Americans Connected and Empowered (F.A.C.E.) Diabetes initiative, are teaming up with The Tom Joyner Morning Show (TJMS) for the 9th annual Take a Loved One to the Doctor Day, taking place on September 28, 2010.
Take a Loved One to the Doctor Day is the culmination of a six-month initiative that seeks to motivate African-Americans to become more proactive about their health and the health of their loved ones through health screenings, immunizations, blood pressure exams and more. This year, F.A.C.E. Diabetes, Stone and Anderson are joining the movement to strengthen the program's diabetes education efforts with workshops and resources in key cities. F.A.C.E. Diabetes will be part of the seven-city Doctor Day live broadcast in Atlanta, Dallas, Detroit, Kansas City, Philadelphia, Raleigh and Washington, D.C. Stone will make a special appearance in Detroit, and Anderson in Philadelphia, where they'll share their personal stories and inspire African-Americans to overcome key barriers to success in living with diabetes.
"Lilly and the F.A.C.E. Diabetes initiative are proud to take part in Take a Loved One to the Doctor Day to empower patients living with diabetes," said Keith Johns, Senior Director of Marketing, Lilly Diabetes. "We hope that these events planned in cities across the country encourage African-Americans to speak with their healthcare providers about desired lifestyle changes to better manage their disease."
As the "faces" of F.A.C.E. Diabetes, Stone and Anderson visit local communities to raise awareness of the diabetes epidemic that affects nearly 15 percent of African-American adults, and to foster the lifestyle changes that can help those with diabetes better manage the disease.(1) Research shows 3.7 million African-Americans aged 20 or older have diabetes.(1) Through community-based events such as Take a Loved One to the Doctor Day, TJMS and Lilly hope to provide valuable information and culturally-relevant solutions to help overcome the everyday challenges that many African-Americans face while living with diabetes.
"We know the statistics and now it's time to lower them," said Tom Joyner, whose morning show reaches over 8 million listeners. "Going to the doctor is the first step, but the follow through is just as important and that includes managing our conditions. Companies like Lilly reach out to our community and make a difference."
The event in Detroit, featuring Stone, will be held at the Northwest Activities Center from 6 a.m. - 2 p.m. and activities in Philadelphia featuring Anderson will be at the New Covenant Church of Philadelphia from 6 a.m. - 5 p.m. For more information on all other F.A.C.E. Diabetes offerings surrounding the Take a Loved One to the Doctor Day or the F.A.C.E. Diabetes initiative, please visit www.FACE-Diabetes.com.
Take a Loved One to the Doctor Day is the culmination of a six-month initiative that seeks to motivate African-Americans to become more proactive about their health and the health of their loved ones through health screenings, immunizations, blood pressure exams and more. This year, F.A.C.E. Diabetes, Stone and Anderson are joining the movement to strengthen the program's diabetes education efforts with workshops and resources in key cities. F.A.C.E. Diabetes will be part of the seven-city Doctor Day live broadcast in Atlanta, Dallas, Detroit, Kansas City, Philadelphia, Raleigh and Washington, D.C. Stone will make a special appearance in Detroit, and Anderson in Philadelphia, where they'll share their personal stories and inspire African-Americans to overcome key barriers to success in living with diabetes.
"Lilly and the F.A.C.E. Diabetes initiative are proud to take part in Take a Loved One to the Doctor Day to empower patients living with diabetes," said Keith Johns, Senior Director of Marketing, Lilly Diabetes. "We hope that these events planned in cities across the country encourage African-Americans to speak with their healthcare providers about desired lifestyle changes to better manage their disease."
As the "faces" of F.A.C.E. Diabetes, Stone and Anderson visit local communities to raise awareness of the diabetes epidemic that affects nearly 15 percent of African-American adults, and to foster the lifestyle changes that can help those with diabetes better manage the disease.(1) Research shows 3.7 million African-Americans aged 20 or older have diabetes.(1) Through community-based events such as Take a Loved One to the Doctor Day, TJMS and Lilly hope to provide valuable information and culturally-relevant solutions to help overcome the everyday challenges that many African-Americans face while living with diabetes.
"We know the statistics and now it's time to lower them," said Tom Joyner, whose morning show reaches over 8 million listeners. "Going to the doctor is the first step, but the follow through is just as important and that includes managing our conditions. Companies like Lilly reach out to our community and make a difference."
The event in Detroit, featuring Stone, will be held at the Northwest Activities Center from 6 a.m. - 2 p.m. and activities in Philadelphia featuring Anderson will be at the New Covenant Church of Philadelphia from 6 a.m. - 5 p.m. For more information on all other F.A.C.E. Diabetes offerings surrounding the Take a Loved One to the Doctor Day or the F.A.C.E. Diabetes initiative, please visit www.FACE-Diabetes.com.
Monday, September 20, 2010
Johnson & Johnson and Crucell in advanced negotiations for an all cash public offer of €24.75 per ordinary share of Crucell
Johnson & Johnson and Crucell N.V. announced that they are in advanced negotiations for a potential public offer by Johnson & Johnson or an affiliate for all outstanding ordinary shares of Crucell not already held by Johnson & Johnson and its affiliates. Johnson & Johnson, through an affiliate, currently holds approximately 17.9 percent of the outstanding shares of Crucell and has submitted a statement on Schedule 13D to the U.S. Securities and Exchange Commission in connection with its change in investment intent with respect to Crucell.
Under the terms of the negotiations, which are at an advanced stage, Johnson & Johnson or an affiliate would acquire all outstanding equity of Crucell that it does not already own for approximately €1.75 billion, which represents a purchase price of €24.75 per share. The public offer would be an all cash transaction.
This potential transaction would enable Crucell to benefit from Johnson & Johnson’s expertise and experience in the development and commercialization of pharmaceutical products. The companies expect that Crucell’s strength in the manufacture, discovery and commercialization of vaccines would create a strong platform for Johnson & Johnson in the vaccine market. After closing of the potential transaction Johnson & Johnson expects to maintain Crucell’s existing facilities, to retain Crucell’s senior management and, generally, to maintain current employment levels. Johnson & Johnson also intends to keep Crucell as the center for vaccines within the Johnson & Johnson pharmaceutical group, and to maintain Crucell’s headquarters in Leiden.
Both companies expect that Crucell, as Johnson & Johnson’s vaccine center, would retain its entrepreneurial culture that has fostered innovation and growth. Johnson & Johnson intends to continue to invest in the continued development of Crucell’s products and pipeline and support Crucell’s mission to increase the number of people around the globe protected from infectious diseases.
In accordance with customary Dutch practice, and to adequately protect the interest of any minority shareholders, Johnson & Johnson expects to retain two independent supervisory directors after closing for such time as is necessary for Johnson & Johnson to acquire all of the outstanding equity of Crucell.
While the parties are still in negotiations with respect to the terms of a definitive agreement for the potential transaction, any proposed transaction would be subject to customary pre-offer conditions, including consultation with the relevant works council and trade unions, and customary offer conditions.
The Board of Directors of Johnson & Johnson and the Supervisory Board of Crucell have authorized the companies to proceed with these negotiations for a potential transaction. Although Johnson & Johnson’s due diligence is substantially complete, the transaction remains subject to negotiation of terms of a definitive agreement and receipt of internal approvals of Johnson & Johnson management and the Management and Supervisory Boards of Crucell. There can be no assurances that a definitive agreement will be entered into and that discussions will result in a transaction. In addition, the terms of any potential transaction may be different from what is described in this press release.
Under the terms of the negotiations, which are at an advanced stage, Johnson & Johnson or an affiliate would acquire all outstanding equity of Crucell that it does not already own for approximately €1.75 billion, which represents a purchase price of €24.75 per share. The public offer would be an all cash transaction.
This potential transaction would enable Crucell to benefit from Johnson & Johnson’s expertise and experience in the development and commercialization of pharmaceutical products. The companies expect that Crucell’s strength in the manufacture, discovery and commercialization of vaccines would create a strong platform for Johnson & Johnson in the vaccine market. After closing of the potential transaction Johnson & Johnson expects to maintain Crucell’s existing facilities, to retain Crucell’s senior management and, generally, to maintain current employment levels. Johnson & Johnson also intends to keep Crucell as the center for vaccines within the Johnson & Johnson pharmaceutical group, and to maintain Crucell’s headquarters in Leiden.
Both companies expect that Crucell, as Johnson & Johnson’s vaccine center, would retain its entrepreneurial culture that has fostered innovation and growth. Johnson & Johnson intends to continue to invest in the continued development of Crucell’s products and pipeline and support Crucell’s mission to increase the number of people around the globe protected from infectious diseases.
In accordance with customary Dutch practice, and to adequately protect the interest of any minority shareholders, Johnson & Johnson expects to retain two independent supervisory directors after closing for such time as is necessary for Johnson & Johnson to acquire all of the outstanding equity of Crucell.
While the parties are still in negotiations with respect to the terms of a definitive agreement for the potential transaction, any proposed transaction would be subject to customary pre-offer conditions, including consultation with the relevant works council and trade unions, and customary offer conditions.
The Board of Directors of Johnson & Johnson and the Supervisory Board of Crucell have authorized the companies to proceed with these negotiations for a potential transaction. Although Johnson & Johnson’s due diligence is substantially complete, the transaction remains subject to negotiation of terms of a definitive agreement and receipt of internal approvals of Johnson & Johnson management and the Management and Supervisory Boards of Crucell. There can be no assurances that a definitive agreement will be entered into and that discussions will result in a transaction. In addition, the terms of any potential transaction may be different from what is described in this press release.
European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal.
The confidentiality arrangements allow both Agencies to exchange confidential information as part of their regulatory and scientific processes. Their aim is to promote public and animal health and to protect European and U.S. patients. The types of information covered by the arrangements relate to scientific advice, orphan drug designation, paediatric development, good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports, marketing authorisation procedures and subsequent changes to the marketing authorisations together with post-marketing surveillance.
The confidentiality arrangements cover medicines that are subject to evaluation or authorised under the centralised procedure as well as medicines that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referrals.
These new commitments are based on the achievements of the previous arrangements between the EMA, the European Commission and the FDA.
The current implementation plan remains in force.
The confidentiality arrangements allow both Agencies to exchange confidential information as part of their regulatory and scientific processes. Their aim is to promote public and animal health and to protect European and U.S. patients. The types of information covered by the arrangements relate to scientific advice, orphan drug designation, paediatric development, good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports, marketing authorisation procedures and subsequent changes to the marketing authorisations together with post-marketing surveillance.
The confidentiality arrangements cover medicines that are subject to evaluation or authorised under the centralised procedure as well as medicines that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referrals.
These new commitments are based on the achievements of the previous arrangements between the EMA, the European Commission and the FDA.
The current implementation plan remains in force.
Phase II Study Showed Switching ACS-PCI Patients to Effient(R)/aspirin from Plavix(R)/aspirin Regimen Reduced Maximum Platelet Aggregation After One Week
A study evaluating the level of platelet aggregation achieved after switching from Plavix(R) (clopidogrel) 75 mg once-daily maintenance dosing plus aspirin to Effient(R) (prasugrel) 10 mg once-daily maintenance dosing (MD) in patients with acute coronary syndrome (ACS) was published today in the Journal of the American College of Cardiology. In this Phase II study, ACS patients who were switched to Effient (either 10 mg maintenance dose [MD] or 60 mg loading dose [LD] followed by 10 mg MD) plus aspirin demonstrated a statistically significant greater reduction in Maximum Platelet Aggregation (MPA) after one week when compared with patients who remained on maintenance therapy with clopidogrel. The Switching Anti Platelet Study (SWAP) was sponsored by Daiichi Sankyo Co., Ltd. and Eli Lilly and Company.
Platelet aggregation is a critical step in the formation of blood clots, which pose a significant risk to patients following an ACS event, including heart attack and heart-related chest pain. The study provides further evidence to suggest that Effient reduces platelet aggregation to a greater extent among ACS patients compared to Plavix.
Of the 128 patients who completed the study, 100 patients were eligible to be included in the platelet function analysis. After a 10-14 day run-in phase with open label clopidogrel 75 mg once daily plus aspirin, patients were randomly assigned to one of the following three treatments: remain on clopidogrel 75 mg plus aspirin for 7 days (n=33); switch to prasugrel 10 mg plus aspirin for 7 days (n=36); or switch to prasugrel 60 mg loading dose plus aspirin followed by prasugrel 10 mg plus aspirin daily for 6 days (n=31).
At day 7, MPA (as measured using 20 micromolar ADP) was statistically significantly lower in patients switched to prasugrel 10 mg plus aspirin when compared with the patients who remained on clopidogrel (41.1 percent vs. 55.0 percent, p < 0.0001) and in those patients switched to prasugrel 60 mg LD followed by prasugrel 10 mg MD vs. clopidogrel (41.0 percent vs. 55.0 percent, p < 0.0001).
"These findings are important because they provide new insights into potential differences in the levels of platelet inhibition that can be achieved with dual oral antiplatelet therapy in patients with ACS," said Dominick J. Angiolillo, M.D., assistant professor, Department of Medicine, Division of Cardiology, University of Florida College of Medicine, Jacksonville, and lead author of the paper. "The data showed that Effient plus aspirin may provide additional reduction in platelet aggregation in ACS patients over those taking standard-dose clopidogrel plus aspirin. However, a larger study would be needed to assess the potential impact of switching on cardiovascular outcomes."
Platelet aggregation is a critical step in the formation of blood clots, which pose a significant risk to patients following an ACS event, including heart attack and heart-related chest pain. The study provides further evidence to suggest that Effient reduces platelet aggregation to a greater extent among ACS patients compared to Plavix.
Of the 128 patients who completed the study, 100 patients were eligible to be included in the platelet function analysis. After a 10-14 day run-in phase with open label clopidogrel 75 mg once daily plus aspirin, patients were randomly assigned to one of the following three treatments: remain on clopidogrel 75 mg plus aspirin for 7 days (n=33); switch to prasugrel 10 mg plus aspirin for 7 days (n=36); or switch to prasugrel 60 mg loading dose plus aspirin followed by prasugrel 10 mg plus aspirin daily for 6 days (n=31).
At day 7, MPA (as measured using 20 micromolar ADP) was statistically significantly lower in patients switched to prasugrel 10 mg plus aspirin when compared with the patients who remained on clopidogrel (41.1 percent vs. 55.0 percent, p < 0.0001) and in those patients switched to prasugrel 60 mg LD followed by prasugrel 10 mg MD vs. clopidogrel (41.0 percent vs. 55.0 percent, p < 0.0001).
"These findings are important because they provide new insights into potential differences in the levels of platelet inhibition that can be achieved with dual oral antiplatelet therapy in patients with ACS," said Dominick J. Angiolillo, M.D., assistant professor, Department of Medicine, Division of Cardiology, University of Florida College of Medicine, Jacksonville, and lead author of the paper. "The data showed that Effient plus aspirin may provide additional reduction in platelet aggregation in ACS patients over those taking standard-dose clopidogrel plus aspirin. However, a larger study would be needed to assess the potential impact of switching on cardiovascular outcomes."
GlaxoSmithKline and Genmab refocus development programme for ofatumumab in autoimmune indications
Following the 1st July announcement by GlaxoSmithKline (GSK) and Genmab of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development programme of ofatumumab in autoimmune indications. After review of the programme’s full development strategy, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.
Based on the positive results from the Phase I/II study in multiple sclerosis (MS) that were announced on 10th September, GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011 following discussion with regulatory authorities. Further work in rheumatoid arthritis (RA) with a subcutaneous administration of ofatumumab is under review.
“Although the intravenous delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune programme is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability” said Ian Tomlinson, SVP Biopharmaceuticals R&D, GSK.
“Genmab initiated the early development of ofatumumab in the autoimmune indications and we are pleased and highly supportive of GSK’s continued commitment to the development of ofatumumab in these chronic diseases,” said Jan G. J. van de Winkel, Ph.D., President and CEO, Genmab.
Ofatumumab is currently not licensed for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.
Based on the positive results from the Phase I/II study in multiple sclerosis (MS) that were announced on 10th September, GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011 following discussion with regulatory authorities. Further work in rheumatoid arthritis (RA) with a subcutaneous administration of ofatumumab is under review.
“Although the intravenous delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune programme is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability” said Ian Tomlinson, SVP Biopharmaceuticals R&D, GSK.
“Genmab initiated the early development of ofatumumab in the autoimmune indications and we are pleased and highly supportive of GSK’s continued commitment to the development of ofatumumab in these chronic diseases,” said Jan G. J. van de Winkel, Ph.D., President and CEO, Genmab.
Ofatumumab is currently not licensed for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.
Monday, September 13, 2010
Genzyme Announces Agreement to Sell Genetic Testing Business to LabCorp
Genzyme Corporation announced that it has entered into an asset purchase agreement under which Laboratory Corporation of America Holdings (LabCorp) will acquire Genzyme Genetics for $925 million in cash.
Under the terms of the agreement, LabCorp will purchase the business in its entirety, including all testing services, technology, intellectual property rights, and its nine testing laboratories. LabCorp is committed to offer employment to the unit's approximately 1900 employees upon closing, including senior management. The agreement is subject to customary closing conditions, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, with the goal of closing before the end of the year.
"This transaction demonstrates the strategic value of Genzyme Genetics and the strong franchise we've built over a twenty year period," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corporation. "It also shows how our management team is uniquely positioned to unlock the underappreciated value of Genzyme’s diverse businesses for shareholders. The completion of this sale allows us to focus our resources on core growth areas and create stronger returns on invested capital."
Genzyme announced in May that it would seek strategic alternatives for three units as part of a five-part plan to increase shareholder value. The plan builds on the robust set of operational, organizational and board changes made over the past year to strengthen the company. Plans to divest the two other Genzyme business units, Diagnostic Products and Pharmaceutical intermediates, remain on track. Proceeds from these transactions may be used to finance the second half of the company's $2 billion stock buyback to be completed by May 2011.
Genzyme Genetics is an industry leading provider of reproductive and oncology testing in the United States, specializing in esoteric testing, with nine laboratories performing more than a million tests a year. The business, which also has the largest nationwide network of board-certified genetic counselors, had revenue of $371 million in 2009. LabCorp is one of the nation's largest laboratory testing companies specializing in routine testing, with 38 primary testing locations and more than 1,500 patient service centers.
The terms achieved with LabCorp meet the three foundational requirements Genzyme established for divestitures: (1) to recognize the value of employees with appropriate treatment as part of the transaction, (2) to create a future for Genzyme Genetics in which customers continue to be served well, and (3) to create value for Genzyme shareholders.
Mr. Termeer continued, "LabCorp is the right strategic partner for Genzyme Genetics. LabCorp intends to invest in growing its operations. The business will have the opportunity to continue to grow, serve its customers and fulfill its potential to bring continued innovation to important areas of the diagnostics field."
Genzyme was advised by Credit Suisse and Goldman Sachs & Co on this transaction. The company's legal adviser was Ropes & Gray.
Under the terms of the agreement, LabCorp will purchase the business in its entirety, including all testing services, technology, intellectual property rights, and its nine testing laboratories. LabCorp is committed to offer employment to the unit's approximately 1900 employees upon closing, including senior management. The agreement is subject to customary closing conditions, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, with the goal of closing before the end of the year.
"This transaction demonstrates the strategic value of Genzyme Genetics and the strong franchise we've built over a twenty year period," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corporation. "It also shows how our management team is uniquely positioned to unlock the underappreciated value of Genzyme’s diverse businesses for shareholders. The completion of this sale allows us to focus our resources on core growth areas and create stronger returns on invested capital."
Genzyme announced in May that it would seek strategic alternatives for three units as part of a five-part plan to increase shareholder value. The plan builds on the robust set of operational, organizational and board changes made over the past year to strengthen the company. Plans to divest the two other Genzyme business units, Diagnostic Products and Pharmaceutical intermediates, remain on track. Proceeds from these transactions may be used to finance the second half of the company's $2 billion stock buyback to be completed by May 2011.
Genzyme Genetics is an industry leading provider of reproductive and oncology testing in the United States, specializing in esoteric testing, with nine laboratories performing more than a million tests a year. The business, which also has the largest nationwide network of board-certified genetic counselors, had revenue of $371 million in 2009. LabCorp is one of the nation's largest laboratory testing companies specializing in routine testing, with 38 primary testing locations and more than 1,500 patient service centers.
The terms achieved with LabCorp meet the three foundational requirements Genzyme established for divestitures: (1) to recognize the value of employees with appropriate treatment as part of the transaction, (2) to create a future for Genzyme Genetics in which customers continue to be served well, and (3) to create value for Genzyme shareholders.
Mr. Termeer continued, "LabCorp is the right strategic partner for Genzyme Genetics. LabCorp intends to invest in growing its operations. The business will have the opportunity to continue to grow, serve its customers and fulfill its potential to bring continued innovation to important areas of the diagnostics field."
Genzyme was advised by Credit Suisse and Goldman Sachs & Co on this transaction. The company's legal adviser was Ropes & Gray.
Novartis announces Russian regulatory approval for Gilenya®
The Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, has granted approval for Gilenya® (fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting multiple sclerosis (MS). Approximately 85% of patients with MS are estimated to have the relapsing remitting form at the onset of disease[1]. Russia is the first country to approve Gilenya, providing a new treatment option offering significant efficacy for patients in the convenience of an oral capsule. Novartis expects to launch Gilenya in Russia in early 2011.
In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously recommended approval of Gilenya and action from the FDA is expected in September 2010. Gilenya is also under review by the European Medicines Agency (EMA) as well as other health authorities worldwide.
Data from one of the largest-ever Phase III clinical trial programs conducted in MS were submitted to support the regulatory submissions. These studies provided evidence of the efficacy of Gilenya in reducing relapses, disability progression and brain lesions in patients with relapsing remitting MS as well as safety data. Gilenya is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya provides selective and reversible retention of lymphocytes in lymph nodes, preserving key immune functions and flexibility in patient management.
In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously recommended approval of Gilenya and action from the FDA is expected in September 2010. Gilenya is also under review by the European Medicines Agency (EMA) as well as other health authorities worldwide.
Data from one of the largest-ever Phase III clinical trial programs conducted in MS were submitted to support the regulatory submissions. These studies provided evidence of the efficacy of Gilenya in reducing relapses, disability progression and brain lesions in patients with relapsing remitting MS as well as safety data. Gilenya is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya provides selective and reversible retention of lymphocytes in lymph nodes, preserving key immune functions and flexibility in patient management.
U.S. Court of Appeals Reverses Third-Party Payor Class Certification Suit Against Lilly
Eli Lilly and Company announced that the U.S. Court of Appeals for the Second Circuit has agreed with Lilly's position that a class should not have been certified in a pending third-party payor suit, in which unions and insurers who act as third-party payors alleged that they overpaid for Zyprexa prescriptions. The court also agreed with Lilly that plaintiffs' overpricing claims should not go forward.
"We are very pleased with today's ruling from the Court of Appeals," said Robert A. Armitage, senior vice president and general counsel for Lilly. "We were confident that the suit filed by third-party payors was without merit and believed that the earlier decision would be overturned."
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. C-LLY
This press release contains forward-looking statements about litigation related to Zyprexa. These statements are based on management's current expectations, but actual results may differ materially. There can be no assurance that the company will prevail in any future proceedings in this litigation or in any other litigation. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.
"We are very pleased with today's ruling from the Court of Appeals," said Robert A. Armitage, senior vice president and general counsel for Lilly. "We were confident that the suit filed by third-party payors was without merit and believed that the earlier decision would be overturned."
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. C-LLY
This press release contains forward-looking statements about litigation related to Zyprexa. These statements are based on management's current expectations, but actual results may differ materially. There can be no assurance that the company will prevail in any future proceedings in this litigation or in any other litigation. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.
Saturday, September 11, 2010
Survey Reveals Roughly 3 in 5 Women May be Mistreating Their Yeast Infections
The MONISTAT® Brand aims to Cure Confusion by educating women about effective treatment options
Few women go through life having never suffered from the uncomfortable symptoms of a yeast infection. In fact, nearly 3 in 4 (72 percent) women will experience their first yeast infection before age 25.[1] Furthermore, the incidence of yeast infections is highest among young women ages 18-24[2], who are new to the category and uncertain about symptoms and available treatment options. According to a recent survey of women ages 18-24 commissioned by the MONISTAT® Brand, sixty-one percent (61 percent) of young women are unsure about which, if any, over the-counter products can cure a yeast infection.
“Many women don’t realize that once they’ve identified they have a yeast infection they can easily treat it on their own terms,” said Dr. Suzanne Gilberg-Lenz, a board-certified OB/GYN who practices in Beverly Hills, California. Dr. Lenz, a partner in the MONISTAT® survey, reviewed the full results and offers the following advice to help cure the confusion around yeast infections:
Cure vs. Care
* More than 1/3 (37 percent) of women incorrectly believe that treating the symptoms of a yeast infection is the same as curing the infection.
“I see many women who have unsuccessfully tried to treat their yeast infections,” said Dr. Lenz. “One of the biggest mistakes I see my patients make is using external symptom relief creams, such as Vagisil®[3], to treat a yeast infection. Vagisil®[4] does not cure the infection; it only temporarily masks or relieves symptoms.”
Over-the-Counter Cure
* Thirty-eight percent (38 percent) of women mistakenly believe a yeast infection can only be cured by a doctor’s prescription.
“While there are prescription treatments available, they can sometimes take 24 – 48 hours to start working,” said Dr. Lenz. “If you know you have a yeast infection and you are in good health, try an over-the-counter remedy like MONISTAT® right away to cure the infection and treat the symptoms. The brand has a portfolio of products, including 1-, 3- and 7-Day treatments, to suit individual women’s needs, which are scientifically proven to be safe and effective.”
Know Before You Go
* The majority of women (60 percent) have been unsure whether or not their symptoms were those of a yeast infection.
“The symptoms of a yeast infection vary greatly among individuals,” said Dr. Lenz. “The classic symptoms – thick, white and lumpy discharge, itching and burning – do not appear for all women. The important sign is always vaginal discomfort that develops out of the blue. If you are unsure, especially if you’ve never had a yeast infection, check with your doctor to make sure your symptoms aren’t actually the result of a sexually transmitted disease, bacterial infection or a combination of yeast and bacteria.”
“If your yeast infection does not clear up, contact your doctor,” adds Dr. Lenz. “Once you’ve treated the infection, long-term, preventative measures, including changes to your diet and lifestyle, can help prevent future infections.”
With 35 years of proven efficacy,MONISTAT® is the #1 Doctor Recommended over-the-counter cure that begins the cure on contact. For more information about the signs, symptoms of and treatment options for yeast infections, and to hear more from Dr. Lenz, visit www.Monistat.com.
Few women go through life having never suffered from the uncomfortable symptoms of a yeast infection. In fact, nearly 3 in 4 (72 percent) women will experience their first yeast infection before age 25.[1] Furthermore, the incidence of yeast infections is highest among young women ages 18-24[2], who are new to the category and uncertain about symptoms and available treatment options. According to a recent survey of women ages 18-24 commissioned by the MONISTAT® Brand, sixty-one percent (61 percent) of young women are unsure about which, if any, over the-counter products can cure a yeast infection.
“Many women don’t realize that once they’ve identified they have a yeast infection they can easily treat it on their own terms,” said Dr. Suzanne Gilberg-Lenz, a board-certified OB/GYN who practices in Beverly Hills, California. Dr. Lenz, a partner in the MONISTAT® survey, reviewed the full results and offers the following advice to help cure the confusion around yeast infections:
Cure vs. Care
* More than 1/3 (37 percent) of women incorrectly believe that treating the symptoms of a yeast infection is the same as curing the infection.
“I see many women who have unsuccessfully tried to treat their yeast infections,” said Dr. Lenz. “One of the biggest mistakes I see my patients make is using external symptom relief creams, such as Vagisil®[3], to treat a yeast infection. Vagisil®[4] does not cure the infection; it only temporarily masks or relieves symptoms.”
Over-the-Counter Cure
* Thirty-eight percent (38 percent) of women mistakenly believe a yeast infection can only be cured by a doctor’s prescription.
“While there are prescription treatments available, they can sometimes take 24 – 48 hours to start working,” said Dr. Lenz. “If you know you have a yeast infection and you are in good health, try an over-the-counter remedy like MONISTAT® right away to cure the infection and treat the symptoms. The brand has a portfolio of products, including 1-, 3- and 7-Day treatments, to suit individual women’s needs, which are scientifically proven to be safe and effective.”
Know Before You Go
* The majority of women (60 percent) have been unsure whether or not their symptoms were those of a yeast infection.
“The symptoms of a yeast infection vary greatly among individuals,” said Dr. Lenz. “The classic symptoms – thick, white and lumpy discharge, itching and burning – do not appear for all women. The important sign is always vaginal discomfort that develops out of the blue. If you are unsure, especially if you’ve never had a yeast infection, check with your doctor to make sure your symptoms aren’t actually the result of a sexually transmitted disease, bacterial infection or a combination of yeast and bacteria.”
“If your yeast infection does not clear up, contact your doctor,” adds Dr. Lenz. “Once you’ve treated the infection, long-term, preventative measures, including changes to your diet and lifestyle, can help prevent future infections.”
With 35 years of proven efficacy,MONISTAT® is the #1 Doctor Recommended over-the-counter cure that begins the cure on contact. For more information about the signs, symptoms of and treatment options for yeast infections, and to hear more from Dr. Lenz, visit www.Monistat.com.
GSK signs agreement with Lonza to secure capacity and expertise in biological manufacturing to support ongoing development of GSK’s biopharmaceuticals portfolio
GlaxoSmithKline (GSK) and Lonza today announced that they have entered into a new agreement under which Lonza will support the ongoing development of GSK’s biopharmaceutical pipeline by supplying manufacturing capacity for five early stage monoclonal antibodies.
Under the terms of the agreement, Lonza will initially manufacture clinical trial batches of five compounds currently in Phase 1 and 2 for GSK. Lonza will also provide access to flexible capacity to enable GSK to respond to future demand, dependent upon progression of molecules through late stage development and commercial launch. All other details of the agreement remain confidential.
“We believe this is a critical step in the ongoing and future success of GSK in biopharmaceuticals”, said Ian Tomlinson, Head of Biopharm Research and Development, GSK. “Our goal is to establish a portfolio of biopharmaceutical products that by 2015 consistently exceeds 20 per cent of our R&D pipeline. To make this a reality we need to ensure that we have the right resources in place, which include flexible and expert manufacturing capabilities, to enable us to ultimately create and deliver these future medicines to patients.”
To support the ongoing expansion of GSK biopharmaceuticals portfolio, GSK is continuing to progress plans to expand its own biopharmaceutical manufacturing capabilities. As part of the agreement, GSK will work with Lonza to assess options for the design, specification, location and construction of a bespoke biopharmaceutical manufacturing facility within the UK.
“We are delighted to enter into this agreement”, said Dr. Stephan Kutzer, COO of Lonza Custom Manufacturing. “To work with one of the world’s leading pharmaceutical companies on their biopharmaceutical pipeline is a great recognition of our efforts to adopt a collaborative approach with our customers. It allows joint manufacturing asset planning to ensure our customers can bring their pipeline of products to the market in an efficient and timely manner. We see this as a relationship that will bring significant benefits to both parties.”
Under the terms of the agreement, Lonza will initially manufacture clinical trial batches of five compounds currently in Phase 1 and 2 for GSK. Lonza will also provide access to flexible capacity to enable GSK to respond to future demand, dependent upon progression of molecules through late stage development and commercial launch. All other details of the agreement remain confidential.
“We believe this is a critical step in the ongoing and future success of GSK in biopharmaceuticals”, said Ian Tomlinson, Head of Biopharm Research and Development, GSK. “Our goal is to establish a portfolio of biopharmaceutical products that by 2015 consistently exceeds 20 per cent of our R&D pipeline. To make this a reality we need to ensure that we have the right resources in place, which include flexible and expert manufacturing capabilities, to enable us to ultimately create and deliver these future medicines to patients.”
To support the ongoing expansion of GSK biopharmaceuticals portfolio, GSK is continuing to progress plans to expand its own biopharmaceutical manufacturing capabilities. As part of the agreement, GSK will work with Lonza to assess options for the design, specification, location and construction of a bespoke biopharmaceutical manufacturing facility within the UK.
“We are delighted to enter into this agreement”, said Dr. Stephan Kutzer, COO of Lonza Custom Manufacturing. “To work with one of the world’s leading pharmaceutical companies on their biopharmaceutical pipeline is a great recognition of our efforts to adopt a collaborative approach with our customers. It allows joint manufacturing asset planning to ensure our customers can bring their pipeline of products to the market in an efficient and timely manner. We see this as a relationship that will bring significant benefits to both parties.”
GSK announces succession plan for Chief Financial Officer
GlaxoSmithKline plc (GSK) today announces that Julian Heslop is to retire as Chief Financial Officer and Executive Director of the company at the end of March 2011. He will be succeeded by Simon Dingemans who is appointed Chief Financial Officer designate and Executive Director effective 4 January 2011.
Simon joins GSK from Goldman Sachs where he is currently Managing Director and Partner. He has over 25 years of experience in investment banking, including most recently as leader of Goldman Sachs' European M&A business and before that as head of UK Investment Banking. During this time he has built relationships and offered strategic advice across multiple industry sectors, including pharmaceuticals and consumer healthcare. He has worked closely with GSK for many years, most recently helping to establish ViiV Healthcare, a new world-leading, specialist HIV company.
Andrew Witty, Chief Executive Officer, GlaxoSmithKline, said: “Our objective is to deliver long-term value to shareholders and, in a period of significant change for our sector, Simon’s appointment as CFO reflects the need for GSK to operate with both creativity and continued financial discipline. In joining our Executive Team, Simon will bring valuable experience and capability to support us in our strategy to grow and diversify GSK’s business through organic means and bolt-on acquisitions. He will also be responsible for delivering cost savings from our global restructuring programme and implementing further measures to simplify our operational model. I am delighted that someone of his calibre will be joining GSK.
Today’s announcement marks the culmination of a comprehensive process to ensure continued excellent leadership of our financial organisation. I would like to pay tribute to Julian, who has served GSK with distinction as CFO for the last 5 years. His integrity, diligence and outstanding technical ability have ensured that GSK has remained financially strong during a period of significant economic turmoil. His support to me, as CEO, has been tremendously valuable and I wish him well in his future endeavours.”
Simon joins GSK from Goldman Sachs where he is currently Managing Director and Partner. He has over 25 years of experience in investment banking, including most recently as leader of Goldman Sachs' European M&A business and before that as head of UK Investment Banking. During this time he has built relationships and offered strategic advice across multiple industry sectors, including pharmaceuticals and consumer healthcare. He has worked closely with GSK for many years, most recently helping to establish ViiV Healthcare, a new world-leading, specialist HIV company.
Andrew Witty, Chief Executive Officer, GlaxoSmithKline, said: “Our objective is to deliver long-term value to shareholders and, in a period of significant change for our sector, Simon’s appointment as CFO reflects the need for GSK to operate with both creativity and continued financial discipline. In joining our Executive Team, Simon will bring valuable experience and capability to support us in our strategy to grow and diversify GSK’s business through organic means and bolt-on acquisitions. He will also be responsible for delivering cost savings from our global restructuring programme and implementing further measures to simplify our operational model. I am delighted that someone of his calibre will be joining GSK.
Today’s announcement marks the culmination of a comprehensive process to ensure continued excellent leadership of our financial organisation. I would like to pay tribute to Julian, who has served GSK with distinction as CFO for the last 5 years. His integrity, diligence and outstanding technical ability have ensured that GSK has remained financially strong during a period of significant economic turmoil. His support to me, as CEO, has been tremendously valuable and I wish him well in his future endeavours.”
Maxx Medical Launches Freedom Total Knee® System In India
Maxx Medical, a Singapore based medical device company with global research and manufacturing subsidiaries in the USA, launched Freedom Total Knee® System in the country today. The Freedom knee is the first joint replacement system designed especially for the Asians. Renowned international cricketer and MP, Mr. Navjot Singh Sidhu was the guest of honor.
Addressing the press meeting, Mr. Tarak Buch, Director, Maxx Medical said, "Freedom Knee has been designed keeping in mind the specific requirements of Asian patients. Currently available knee replacement systems are based on Caucasian anatomy dimensions. Asian (Indian) anatomy is known to be significantly different from the Caucasians, and this fact has been well documented globally. Our Research Team worked for more than 5 years, using powerful computing technology and world class testing facilities to develop a system which will provide perfect fit for the Asian Knee anatomy. Freedom Knee system already has US FDA approval, CE (European approval and DCGI (India) approval. At Maxx Medical we always strive to provide implants and services that will help the patients in restoring their mobility and Pursue life!"
"In Punjab osteo-arthritis is one of the most common articular disease attacking people in the age group of 50 years and above and it is rampantly increasing. More than 50% of elderly population in Amritsar is suffering from arthritis and many of them need to undergo joint replacements surgery. Diseases like arthritis can make a person immobile with severe pain, hampering their personal and social life. This is for the first time that a company has designed a knee especially for the Asian patients. It is indeed a medical breakthrough; this knee joint system will provide minimum bone cutting which is a boon for the patients as well as surgeons as Asians are known to have less bone stock. Also, this knee provides high-flexion to carry out day today activities of the patients independently without any support." says Dr. Avtar Singh, Chief Orthopedic Surgeon, Amandeep Hospital, and Amritsar
On the occasion Mr. Navjot Singh Siddhu said, "I would like to congratulate Maxx Medical for developing such a wonderful and relevant technology. From decades we have been using various kinds of knee replacement devices but it gives me immense joy to know that there is a device which has been specifically developed for us. I am hopeful that my fellow countrymen will benefit greatly from this product."
Addressing the press meeting, Mr. Tarak Buch, Director, Maxx Medical said, "Freedom Knee has been designed keeping in mind the specific requirements of Asian patients. Currently available knee replacement systems are based on Caucasian anatomy dimensions. Asian (Indian) anatomy is known to be significantly different from the Caucasians, and this fact has been well documented globally. Our Research Team worked for more than 5 years, using powerful computing technology and world class testing facilities to develop a system which will provide perfect fit for the Asian Knee anatomy. Freedom Knee system already has US FDA approval, CE (European approval and DCGI (India) approval. At Maxx Medical we always strive to provide implants and services that will help the patients in restoring their mobility and Pursue life!"
"In Punjab osteo-arthritis is one of the most common articular disease attacking people in the age group of 50 years and above and it is rampantly increasing. More than 50% of elderly population in Amritsar is suffering from arthritis and many of them need to undergo joint replacements surgery. Diseases like arthritis can make a person immobile with severe pain, hampering their personal and social life. This is for the first time that a company has designed a knee especially for the Asian patients. It is indeed a medical breakthrough; this knee joint system will provide minimum bone cutting which is a boon for the patients as well as surgeons as Asians are known to have less bone stock. Also, this knee provides high-flexion to carry out day today activities of the patients independently without any support." says Dr. Avtar Singh, Chief Orthopedic Surgeon, Amandeep Hospital, and Amritsar
On the occasion Mr. Navjot Singh Siddhu said, "I would like to congratulate Maxx Medical for developing such a wonderful and relevant technology. From decades we have been using various kinds of knee replacement devices but it gives me immense joy to know that there is a device which has been specifically developed for us. I am hopeful that my fellow countrymen will benefit greatly from this product."
Tuesday, September 7, 2010
iBio and Fraunhofer execute business development and marketing agreement with GE Healthcare
iBio, Inc., its development collaborator, Fraunhofer USA Center for Molecular Biotechnology (CMB), and GE Healthcare, a unit of General Electric Company announced their entry into an agreement to jointly develop and globally market manufacturing solutions for biopharmaceuticals and vaccines based upon their respective proprietary technologies. Financial terms are not being disclosed.
This new business initiative combines the value of GE Healthcare’s capabilities and worldwide presence in life sciences, iBio’s highly efficient iBioLaunch™ plant-based vaccine and therapeutic protein manufacturing platform, and CMB’s advanced vaccine and molecular biology expertise.
iBioLaunch plant-based technology enables the production of vaccine and therapeutic proteins at substantially lower capital and operating costs than are possible with other technologies. GE Healthcare has developed solutions and offerings including those which enable customers to build processes and facilities based on single-use and ready-to-use technologies.
In this collaboration with iBio and CMB, GE Healthcare will supply bioprocessing products and process expertise for integration with the iBioLaunch platform. It will also support the development of products based on the IBioLaunch platform and product offering.
The manufacturing solutions covered by the agreement include product licenses, technology transfer services, design of upstream and downstream manufacturing processes; supplies of equipment, consumables and related validation support, construction of buildings, facility operations and related financial services.
“This is an exciting development in GE Healthcare’s strategy to deliver more efficient and cost-effective biopharmaceutical and vaccine manufacturing technologies,” said Nigel Darby, Vice President, Biotechnologies, GE Healthcare.
“We expect this relationship with GE Healthcare to accelerate and broaden market penetration for our technology through access to GE Healthcare’s existing relationships and its skill and experience with project implementation and process development,” said Robert B. Kay, Chairman and CEO of iBio. “This is another implementation of our model to affiliate and out-source with best-in-class collaborators like GE Healthcare and CMB as the fastest and lowest risk path to revenue growth.”
”We have already done considerable planning and work with GE Healthcare to prepare for implementation of this agreement,” said Dr. Vidadi Yusibov, Executive Director of CMB and Chief Scientific Officer of iBio. “Therefore, we expect this relationship to start quickly and continue long after its initial three-year term to provide important results for our collective customers as we combine GE Healthcare’s products, skills and relationships with the technology we developed and are implementing in our new Delaware facility.”
This new business initiative combines the value of GE Healthcare’s capabilities and worldwide presence in life sciences, iBio’s highly efficient iBioLaunch™ plant-based vaccine and therapeutic protein manufacturing platform, and CMB’s advanced vaccine and molecular biology expertise.
iBioLaunch plant-based technology enables the production of vaccine and therapeutic proteins at substantially lower capital and operating costs than are possible with other technologies. GE Healthcare has developed solutions and offerings including those which enable customers to build processes and facilities based on single-use and ready-to-use technologies.
In this collaboration with iBio and CMB, GE Healthcare will supply bioprocessing products and process expertise for integration with the iBioLaunch platform. It will also support the development of products based on the IBioLaunch platform and product offering.
The manufacturing solutions covered by the agreement include product licenses, technology transfer services, design of upstream and downstream manufacturing processes; supplies of equipment, consumables and related validation support, construction of buildings, facility operations and related financial services.
“This is an exciting development in GE Healthcare’s strategy to deliver more efficient and cost-effective biopharmaceutical and vaccine manufacturing technologies,” said Nigel Darby, Vice President, Biotechnologies, GE Healthcare.
“We expect this relationship with GE Healthcare to accelerate and broaden market penetration for our technology through access to GE Healthcare’s existing relationships and its skill and experience with project implementation and process development,” said Robert B. Kay, Chairman and CEO of iBio. “This is another implementation of our model to affiliate and out-source with best-in-class collaborators like GE Healthcare and CMB as the fastest and lowest risk path to revenue growth.”
”We have already done considerable planning and work with GE Healthcare to prepare for implementation of this agreement,” said Dr. Vidadi Yusibov, Executive Director of CMB and Chief Scientific Officer of iBio. “Therefore, we expect this relationship to start quickly and continue long after its initial three-year term to provide important results for our collective customers as we combine GE Healthcare’s products, skills and relationships with the technology we developed and are implementing in our new Delaware facility.”
GlaxoSmithKline pre-broadcast statement: BBC Panorama, 6 September 2010
GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, 'A risk worth taking?' which is scheduled to be aired this evening.
We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes. This is a chronic and serious disease that if left untreated can result in serious health problems.
Patients concerned by the programme should seek advice from their doctor and not stop their medication.
The company has not seen the programme but denies any suggestions that it has put patients at risk. We consider patient safety a priority.
Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.
We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. No other diabetes medicine introduced in the last 10 years has such an extensive safety database. The results from this research programme have been given to regulatory authorities worldwide.
Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.
Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines. We continue to believe that Avandia is safe and effective when it is prescribed appropriately.
The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data on Avandia.
The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.
In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the "secret tape the drug company would rather you didn't hear."
On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website www.gsk.com.
The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.
For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia.
We have diligently shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.
We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.
We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes. This is a chronic and serious disease that if left untreated can result in serious health problems.
Patients concerned by the programme should seek advice from their doctor and not stop their medication.
The company has not seen the programme but denies any suggestions that it has put patients at risk. We consider patient safety a priority.
Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.
We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. No other diabetes medicine introduced in the last 10 years has such an extensive safety database. The results from this research programme have been given to regulatory authorities worldwide.
Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.
Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines. We continue to believe that Avandia is safe and effective when it is prescribed appropriately.
The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data on Avandia.
The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.
In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the "secret tape the drug company would rather you didn't hear."
On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website www.gsk.com.
The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.
For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia.
We have diligently shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.
We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.
Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naïve HIV-1-infected adults.
It is estimated that 33.4 million people are living with HIV worlsudwide,[1] 2.3 million of which are in Europe.[2] Research shows that antiretrovirals have helped to extend life expectancy for people living with HIV.[3] However, new treatments are needed which suppress the replication of the virus while also minimizing the occurrence of unwanted side effects.[4]
The TMC278 filing is based on an extensive global clinical development programme involving more than 1,350 patients [5] in over 20 countries. If approved, TMC278 would help to expand the treatment options for people living with HIV.
“Thanks to advances in treatment, people with HIV are living longer than ever before, which is made possible by continuous research for new and improved treatments,” said Eric Lefebvre, Medical Director at Tibotec. “The EMA regulatory submission for TMC278 represents an important part of our ongoing commitment to HIV and to helping patients receive the treatment and care they need.”
Pending EMA approval, Tibotec will commercialize TMC278 in the European Union. Tibotec has also submitted new drug applications in the US and Canada, and regulatory submissions for TMC278 in other countries are expected in the coming months. Tibotec has entered into a license and collaboration agreement with Gilead Sciences, Inc. (Nasdaq: GILD) for the development and commercialization of a once-daily fixed-dose combination of TMC278 and Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)).
About TMC278
TMC278 is an investigational NNRTI, which blocks the reverse transcriptase, a key enzyme the HIV virus uses to replicate. The regulatory application for TMC278 is based on the 48-week results of two pivotal Phase 3 double-blind, randomized studies recently presented at the International AIDS Congress, known as ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215).5 The studies evaluated the efficacy, safety and tolerability of once-daily TMC278, in combination with two NRTIs, in treatment-naïve HIV-1-infected adults, and both reached their primary objective of demonstrating non-inferiority of TMC278 vs. efavirenz in the percentage of patients achieving an undetectable viral load (less than 50 copies/mL) at week 48 (with a maximum allowable difference of 12 percent).5 The studies showed that TMC278 demonstrated significant improvements in tolerability, with lower rates of discontinuations due to adverse events including dizziness, abnormal dreams and nightmares, and rashes.5
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. The Company’s main research and development facilities are in Beerse, Belgium, with offices in Titusville, NJ, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
About Tibotec, a division of Janssen-Cilag
Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa focusing on patients’ and healthcare providers’ specific needs in this disease domain. The company will also commercialise medicines to combat other viral diseases in the future.
About Janssen-Cilag
Janssen-Cilag is a leader in traditional and biological medicines in areas such as gastroenterology, women’s health, mental health and neurology as well as for pain, oncology, haematology and nephrology.
Tibotec Pharmaceuticals and Janssen-Cilag are subsidiaries of the Johnson & Johnson family of companies.
It is estimated that 33.4 million people are living with HIV worlsudwide,[1] 2.3 million of which are in Europe.[2] Research shows that antiretrovirals have helped to extend life expectancy for people living with HIV.[3] However, new treatments are needed which suppress the replication of the virus while also minimizing the occurrence of unwanted side effects.[4]
The TMC278 filing is based on an extensive global clinical development programme involving more than 1,350 patients [5] in over 20 countries. If approved, TMC278 would help to expand the treatment options for people living with HIV.
“Thanks to advances in treatment, people with HIV are living longer than ever before, which is made possible by continuous research for new and improved treatments,” said Eric Lefebvre, Medical Director at Tibotec. “The EMA regulatory submission for TMC278 represents an important part of our ongoing commitment to HIV and to helping patients receive the treatment and care they need.”
Pending EMA approval, Tibotec will commercialize TMC278 in the European Union. Tibotec has also submitted new drug applications in the US and Canada, and regulatory submissions for TMC278 in other countries are expected in the coming months. Tibotec has entered into a license and collaboration agreement with Gilead Sciences, Inc. (Nasdaq: GILD) for the development and commercialization of a once-daily fixed-dose combination of TMC278 and Gilead’s Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)).
About TMC278
TMC278 is an investigational NNRTI, which blocks the reverse transcriptase, a key enzyme the HIV virus uses to replicate. The regulatory application for TMC278 is based on the 48-week results of two pivotal Phase 3 double-blind, randomized studies recently presented at the International AIDS Congress, known as ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215).5 The studies evaluated the efficacy, safety and tolerability of once-daily TMC278, in combination with two NRTIs, in treatment-naïve HIV-1-infected adults, and both reached their primary objective of demonstrating non-inferiority of TMC278 vs. efavirenz in the percentage of patients achieving an undetectable viral load (less than 50 copies/mL) at week 48 (with a maximum allowable difference of 12 percent).5 The studies showed that TMC278 demonstrated significant improvements in tolerability, with lower rates of discontinuations due to adverse events including dizziness, abnormal dreams and nightmares, and rashes.5
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. The Company’s main research and development facilities are in Beerse, Belgium, with offices in Titusville, NJ, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
About Tibotec, a division of Janssen-Cilag
Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa focusing on patients’ and healthcare providers’ specific needs in this disease domain. The company will also commercialise medicines to combat other viral diseases in the future.
About Janssen-Cilag
Janssen-Cilag is a leader in traditional and biological medicines in areas such as gastroenterology, women’s health, mental health and neurology as well as for pain, oncology, haematology and nephrology.
Tibotec Pharmaceuticals and Janssen-Cilag are subsidiaries of the Johnson & Johnson family of companies.
Johnson's® Brand Launches Johnson's® Natural™ Product Line for Babies and Kids Brings Affordable, Natural Products to All Moms at Mass Retail
Introduces New Website with Educational Videos on “Baby Steps” to Natural Living
JOHNSON’S® Brand, the leading expert in baby skincare, introduces JOHNSON’S® NATURAL™, a line of products that naturally and gently care for baby’s skin and hair featuring at least 98 percent plant and fruit-derived natural ingredients. The new line supports the needs of a growing number of moms looking for natural products as part of a natural lifestyle.
JOHNSON'S® NATURAL™ product line is formulated with a unique combination of at least 98 percent naturally derived ingredients, the iconic NO MORE TEARS® formula and our ALLERFREE™ fragrance, containing subtle notes of white floral, powder and vanilla scents, which is naturally derived and free of known allergens and irritating essential oils. The line consists of five product offerings for moms with children of varying ages: JOHNSON'S® NATURAL™ HEAD-TO-TOE™ Foaming Baby Wash, JOHNSON'S® NATURAL™ Baby Shampoo, JOHNSON'S® NATURAL™ Baby Lotion, JOHNSON'S® NATURAL™ Kids 2-in-1 Kids Hand & Face Foaming Wash, and JOHNSON'S® NATURAL™ Kids 3-in-1 Shampoo, Conditioner & Body Wash.
“JOHNSON’S® is a leader in developing baby products that are mild and gentle to meet the different needs of all moms and caregivers,” says Rich Hildebrandt, group product director for JOHNSON’S® Brand. “We’re thrilled to provide moms with trusted, natural products that are affordable and available at mass retail. Not all natural products are suitable for children, but the new line by JOHNSON’S® is not only designed specifically for babies, it also won’t break the bank.”
To coincide with the launch of the new line, JOHNSON’S® is introducing a new micro site, www.johnsonsnatural.com , where moms can get information about the products and ingredients, receive coupons and view a new video series. The video series entitled “Baby Steps to a Natural Lifestyle,” showcases real moms who offer tips on how to incorporate natural living into everyday family life affordably. The videos feature real-life moms including natural lifestyle expert and author Sara Snow, prominent mommy blogger and co-founder of Cool Mom Picks Kristen Chase, and Holly Ambrose, a mom blogger who regularly works with the National Wildlife Federation.
Recognizing that part of living a natural life for moms includes the ability to introduce little ones to the great outdoors, JOHNSON’S® has teamed up with National Wildlife Federation in support of their efforts to inspire families to spend more time outdoors in nature.
“It’s never too early for moms to spend time in the outdoors with their babies and introduce them to nature at an early age,” says Meri-Margaret Deoudes, National Wildlife Federation. “We’re excited to be working with JOHNSON’S® and have them join our efforts to help parents and families connect with nature.”
The new JOHNSON’S® NATURAL™ product line is now available nationwide at food, drug and mass retail stores, and has suggested retail prices that range from $4.59 for 9 oz. to $6.49 for 18 oz.
JOHNSON'S® Brand from Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc., has a long tradition of providing pure, mild, gentle and clinically-proven products formulated especially for babies. The most trusted name in baby care, JOHNSON'S® Brand is rooted in science and has more than 115-years leadership in the industry; every product undergoes rigorous clinical assessment to ensure it meets our highest standards. JOHNSON'S® Brand takes pride in continuing to create and supply parents and healthcare professionals with the best essentials and innovations in baby care. For more information about the JOHNSON'S® Brand and its product offerings, visit www.johnsonsbaby.com.
JOHNSON’S® Brand, the leading expert in baby skincare, introduces JOHNSON’S® NATURAL™, a line of products that naturally and gently care for baby’s skin and hair featuring at least 98 percent plant and fruit-derived natural ingredients. The new line supports the needs of a growing number of moms looking for natural products as part of a natural lifestyle.
JOHNSON'S® NATURAL™ product line is formulated with a unique combination of at least 98 percent naturally derived ingredients, the iconic NO MORE TEARS® formula and our ALLERFREE™ fragrance, containing subtle notes of white floral, powder and vanilla scents, which is naturally derived and free of known allergens and irritating essential oils. The line consists of five product offerings for moms with children of varying ages: JOHNSON'S® NATURAL™ HEAD-TO-TOE™ Foaming Baby Wash, JOHNSON'S® NATURAL™ Baby Shampoo, JOHNSON'S® NATURAL™ Baby Lotion, JOHNSON'S® NATURAL™ Kids 2-in-1 Kids Hand & Face Foaming Wash, and JOHNSON'S® NATURAL™ Kids 3-in-1 Shampoo, Conditioner & Body Wash.
“JOHNSON’S® is a leader in developing baby products that are mild and gentle to meet the different needs of all moms and caregivers,” says Rich Hildebrandt, group product director for JOHNSON’S® Brand. “We’re thrilled to provide moms with trusted, natural products that are affordable and available at mass retail. Not all natural products are suitable for children, but the new line by JOHNSON’S® is not only designed specifically for babies, it also won’t break the bank.”
To coincide with the launch of the new line, JOHNSON’S® is introducing a new micro site, www.johnsonsnatural.com , where moms can get information about the products and ingredients, receive coupons and view a new video series. The video series entitled “Baby Steps to a Natural Lifestyle,” showcases real moms who offer tips on how to incorporate natural living into everyday family life affordably. The videos feature real-life moms including natural lifestyle expert and author Sara Snow, prominent mommy blogger and co-founder of Cool Mom Picks Kristen Chase, and Holly Ambrose, a mom blogger who regularly works with the National Wildlife Federation.
Recognizing that part of living a natural life for moms includes the ability to introduce little ones to the great outdoors, JOHNSON’S® has teamed up with National Wildlife Federation in support of their efforts to inspire families to spend more time outdoors in nature.
“It’s never too early for moms to spend time in the outdoors with their babies and introduce them to nature at an early age,” says Meri-Margaret Deoudes, National Wildlife Federation. “We’re excited to be working with JOHNSON’S® and have them join our efforts to help parents and families connect with nature.”
The new JOHNSON’S® NATURAL™ product line is now available nationwide at food, drug and mass retail stores, and has suggested retail prices that range from $4.59 for 9 oz. to $6.49 for 18 oz.
JOHNSON'S® Brand from Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc., has a long tradition of providing pure, mild, gentle and clinically-proven products formulated especially for babies. The most trusted name in baby care, JOHNSON'S® Brand is rooted in science and has more than 115-years leadership in the industry; every product undergoes rigorous clinical assessment to ensure it meets our highest standards. JOHNSON'S® Brand takes pride in continuing to create and supply parents and healthcare professionals with the best essentials and innovations in baby care. For more information about the JOHNSON'S® Brand and its product offerings, visit www.johnsonsbaby.com.
Friday, September 3, 2010
Roche provides update on FDA application for T-DM1
Roche announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will continue with its ongoing Phase III EMILIA registration study. Roche will continue to work with the FDA and expects a global regulatory submission of T-DM1 mid 2012.
The BLA submitted in July 2010 requested accelerated approval for T-DM1 based on the results of a single-arm Phase II study, which showed T-DM1 shrank tumors in one-third of women with advanced HER2 positive breast cancer, who had received on average seven prior medicines, including two HER2 targeted agents.
Consideration by the FDA for accelerated approval requires recognition of a defined patient population of unmet need (a life-threatening disease with limited treatment choices), for whom a medicine’s early safety and efficacy data are reasonably likely to predict clinical benefit. Following the pre-submission meeting with the FDA in March 2010, Roche concluded it was appropriate to submit a BLA for accelerated approval. In their review of the BLA, FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.
“We firmly believe in the potential of T-DM1 as a novel HER2 targeted option and remain fully committed to its ongoing development,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche.
Roche will submit the data from the amended Phase III randomized EMILIA study to support a global regulatory submission in mid 2012. The EMILIA study compares T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2 positive breast cancer whose disease has worsened after receiving initial treatment.
T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody, being studied for advanced HER2 positive breast cancer. T-DM1 attaches trastuzumab and the chemotherapy DM1 together using a stable linker, which is designed to keep T-DM1 in one piece until it reaches specific cancer cells. The antibody (trastuzumab) binds to the HER2 positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cells. Then, once T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1. Genentech licenses technology for T-DM1 under an agreement with ImmunoGen, Inc.
About studies with T-DM1 and other HER2 targeted agents
The FDA submission was based on a Phase II study known as TDM4374g, a single-arm, multi-center trial designed to assess single-agent T-DM1 in 110 women with HER2 positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2 targeted treatments (Herceptin and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane and capecitabine. The primary endpoint of the study was objective response rate (a complete or partial tumor shrinkage of at least 30 percent, determined by two tumor assessments at least 28 days apart), as measured by an independent review facility.
Results from the study were presented at the 2009 San Antonio Breast Cancer Symposium and demonstrated that T-DM1 shrank tumors in 33 percent of women with advanced HER2 positive breast cancer that had worsened following treatment with an average of seven prior medicines for metastatic disease. In the study, most side effects were mild (Grade 1-2) and similar to those observed in previous clinical trials of T-DM1. The most common adverse events of any grade were fatigue (62 percent) and nausea (37 percent). The most common severe adverse events (Grade 3 or higher) were a low level of platelets in the blood (7 percent), fatigue (5 percent) and cellulitis (4 percent). No severe cardiac-specific side effects were observed. One patient with pre-existing, non-alcoholic fatty liver disease died with liver failure. The safety results were consistent with data from earlier studies, including a proof-of-concept Phase II study (TDM4258g), which also was included in the submission to the FDA.
Several other Phase II and III trials of T-DM1, and other HER2 targeted medicines are ongoing:
* Preliminary results from a randomized Phase II study (TDM4450g) comparing T-DM1 to Herceptin (trastuzumab) in combination with docetaxel chemotherapy in people who have not been previously treated for their advanced HER2 positive breast cancer have been accepted for presentation at the European Society of Medical Oncology (ESMO) congress in Milan (Italy) in October.
* An ongoing Phase III study, MARIANNE, will compare both T-DM1 alone and T-DM1 in combination with pertuzumab to Herceptin in combination with a taxane chemotherapy in people with advanced HER2 positive breast cancer who have not been previously treated for advanced disease.
* CLEOPATRA is the pivotal registration trial with pertuzumab in combination with Herceptin and docetaxel in first-line HER2 positive metastatic breast cancer. Filing timelines remain unchanged; Roche expects a global regulatory filing of pertuzumab based on the CLEOPATRA study at the end of 2011.
Pertuzumab is a new type of targeted anti-tumor agent called a HER2 dimerisation inhibitor (HDI), which inhibits the pairing (or dimerisation) of the HER2 protein with other HER-family receptors. This pairing is responsible for initiating intracellular HER signaling. HER-signaling pathways are believed to play an important role in the growth and survival of several different cancer types. The modes of action of Herceptin and pertuzumab are believed to be synergistic. Herceptin also binds to HER2, but in a different place.
Herceptin is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumor. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2 positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2 positive breast cancer. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 740,000 patients with HER2 positive breast cancer worldwide.
The BLA submitted in July 2010 requested accelerated approval for T-DM1 based on the results of a single-arm Phase II study, which showed T-DM1 shrank tumors in one-third of women with advanced HER2 positive breast cancer, who had received on average seven prior medicines, including two HER2 targeted agents.
Consideration by the FDA for accelerated approval requires recognition of a defined patient population of unmet need (a life-threatening disease with limited treatment choices), for whom a medicine’s early safety and efficacy data are reasonably likely to predict clinical benefit. Following the pre-submission meeting with the FDA in March 2010, Roche concluded it was appropriate to submit a BLA for accelerated approval. In their review of the BLA, FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.
“We firmly believe in the potential of T-DM1 as a novel HER2 targeted option and remain fully committed to its ongoing development,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche.
Roche will submit the data from the amended Phase III randomized EMILIA study to support a global regulatory submission in mid 2012. The EMILIA study compares T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2 positive breast cancer whose disease has worsened after receiving initial treatment.
T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody, being studied for advanced HER2 positive breast cancer. T-DM1 attaches trastuzumab and the chemotherapy DM1 together using a stable linker, which is designed to keep T-DM1 in one piece until it reaches specific cancer cells. The antibody (trastuzumab) binds to the HER2 positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cells. Then, once T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1. Genentech licenses technology for T-DM1 under an agreement with ImmunoGen, Inc.
About studies with T-DM1 and other HER2 targeted agents
The FDA submission was based on a Phase II study known as TDM4374g, a single-arm, multi-center trial designed to assess single-agent T-DM1 in 110 women with HER2 positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2 targeted treatments (Herceptin and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane and capecitabine. The primary endpoint of the study was objective response rate (a complete or partial tumor shrinkage of at least 30 percent, determined by two tumor assessments at least 28 days apart), as measured by an independent review facility.
Results from the study were presented at the 2009 San Antonio Breast Cancer Symposium and demonstrated that T-DM1 shrank tumors in 33 percent of women with advanced HER2 positive breast cancer that had worsened following treatment with an average of seven prior medicines for metastatic disease. In the study, most side effects were mild (Grade 1-2) and similar to those observed in previous clinical trials of T-DM1. The most common adverse events of any grade were fatigue (62 percent) and nausea (37 percent). The most common severe adverse events (Grade 3 or higher) were a low level of platelets in the blood (7 percent), fatigue (5 percent) and cellulitis (4 percent). No severe cardiac-specific side effects were observed. One patient with pre-existing, non-alcoholic fatty liver disease died with liver failure. The safety results were consistent with data from earlier studies, including a proof-of-concept Phase II study (TDM4258g), which also was included in the submission to the FDA.
Several other Phase II and III trials of T-DM1, and other HER2 targeted medicines are ongoing:
* Preliminary results from a randomized Phase II study (TDM4450g) comparing T-DM1 to Herceptin (trastuzumab) in combination with docetaxel chemotherapy in people who have not been previously treated for their advanced HER2 positive breast cancer have been accepted for presentation at the European Society of Medical Oncology (ESMO) congress in Milan (Italy) in October.
* An ongoing Phase III study, MARIANNE, will compare both T-DM1 alone and T-DM1 in combination with pertuzumab to Herceptin in combination with a taxane chemotherapy in people with advanced HER2 positive breast cancer who have not been previously treated for advanced disease.
* CLEOPATRA is the pivotal registration trial with pertuzumab in combination with Herceptin and docetaxel in first-line HER2 positive metastatic breast cancer. Filing timelines remain unchanged; Roche expects a global regulatory filing of pertuzumab based on the CLEOPATRA study at the end of 2011.
Pertuzumab is a new type of targeted anti-tumor agent called a HER2 dimerisation inhibitor (HDI), which inhibits the pairing (or dimerisation) of the HER2 protein with other HER-family receptors. This pairing is responsible for initiating intracellular HER signaling. HER-signaling pathways are believed to play an important role in the growth and survival of several different cancer types. The modes of action of Herceptin and pertuzumab are believed to be synergistic. Herceptin also binds to HER2, but in a different place.
Herceptin is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumor. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2 positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2 positive breast cancer. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 740,000 patients with HER2 positive breast cancer worldwide.
Roche announces Operational Excellence initiative
Roche announced the launch of a Group-wide Operational Excellence initiative. In view of mounting pressures to curb healthcare costs – especially in the United States and Europe – together with recent developments in late-stage projects in the Roche pipeline, this initiative aims to adapt cost structures and accelerate productivity improvements Group-wide.
Severin Schwan, CEO of Roche, commented: “We have launched this initiative from a position of strength. By contrast with many of our competitors, we are only marginally affected by patent expiries. Furthermore, despite the recent setbacks, we have one of the strongest R&D product pipelines in the industry. We will focus our resources towards investments that will drive innovation and ensure the company’s long-term success, while at the same time protecting our profitability so as to safeguard our financial flexibility. Roche also confirms its full-year outlook for 2010.”
With tightening healthcare budgets, Roche expects that payers will increasingly allocate resources to treatments and diagnostic tools providing the highest medical value for patients. Therefore, Operational Excellence is not simply a cost-reduction effort but is above all about pro-actively setting the right priorities to ensure a successful future.
Over the months ahead, all parts of the organisation will review and analyse their respective structures and processes. Detailed decisions on the measures that will be taken and the potential impact on staffing levels will be announced before the end of the year. The Operational Excellence initiative is scheduled for implementation during 2011 and 2012.
Severin Schwan, CEO of Roche, commented: “We have launched this initiative from a position of strength. By contrast with many of our competitors, we are only marginally affected by patent expiries. Furthermore, despite the recent setbacks, we have one of the strongest R&D product pipelines in the industry. We will focus our resources towards investments that will drive innovation and ensure the company’s long-term success, while at the same time protecting our profitability so as to safeguard our financial flexibility. Roche also confirms its full-year outlook for 2010.”
With tightening healthcare budgets, Roche expects that payers will increasingly allocate resources to treatments and diagnostic tools providing the highest medical value for patients. Therefore, Operational Excellence is not simply a cost-reduction effort but is above all about pro-actively setting the right priorities to ensure a successful future.
Over the months ahead, all parts of the organisation will review and analyse their respective structures and processes. Detailed decisions on the measures that will be taken and the potential impact on staffing levels will be announced before the end of the year. The Operational Excellence initiative is scheduled for implementation during 2011 and 2012.
European Commission Issues Positive Decision for Approval of Seroquel XR
AstraZeneca announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year.
AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.
Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient's diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval.
About SEROQUEL XR
To date, SEROQUEL XR has been approved in 72 countries for schizophrenia, 57 countries for bipolar mania, 49 countries for bipolar depression, 33 countries for bipolar maintenance, 6 countries for MDD, with US receiving approval of SEROQUEL XR for the adjunctive treatment of MDD in December 2009, and 3 countries for Generalised Anxiety Disorder (GAD).
This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year.
AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.
Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient's diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval.
About SEROQUEL XR
To date, SEROQUEL XR has been approved in 72 countries for schizophrenia, 57 countries for bipolar mania, 49 countries for bipolar depression, 33 countries for bipolar maintenance, 6 countries for MDD, with US receiving approval of SEROQUEL XR for the adjunctive treatment of MDD in December 2009, and 3 countries for Generalised Anxiety Disorder (GAD).
Wednesday, September 1, 2010
"Cholera Outbreak in Afghanistan Under Control," Says UN
The cholera outbreak that started earlier this month in central Afghanistan is now under control, the United Nations and its partners reported today, stressing that early detection and collaboration among key actors were key to averting a public health crisis.
The World Health Organization (WHO) and the Ministry of Public Health (MoPH) initiated a response immediately after the outbreak began on 9 August in the Nowa district of Ghazni province.
"Early detection of diseases is tantamount to saving lives," said Peter Graaff, WHO's Representative in Afghanistan.
"Thanks to a strong disease surveillance system and close collaboration between the MoPH, UN agencies and health NGOs [non-governmental organizations] we were quickly able to limit the magnitude of the outbreak and save lives."
Afghanistan's disease early warning system (DEWS) is now operational in all 34 provinces, and includes more than 300 surveillance officers, who help to detect and respond to disease outbreaks within 48 hours.
"In 2009 alone, we were able to rapidly respond to and control 35 cholera outbreaks and treated 1,721 reported cases across 15 provinces," said WHO epidemiologist Rashida Bano.
Cholera is an acute intestinal infection picked up through contaminated food or water. It can result in diarrhoea that can lead to severe dehydration and even death without prompt treatment.
WHO donated life-saving supplies, including cholera kits and other emergency medical supplies in the wake of the outbreak earlier this month, which affected at least 130 people.
Mr. Graaff noted that one of the challenges with regard to cholera control in Afghanistan is the insecurity in parts of the country which make it difficult to carry out timely investigations and responses.
Due to security concerns involving health ministry and UN staff, WHO said that three local NGO staff members were trained in outbreak investigation, including sample collection and treatment.
WHO added that diarrhoeal diseases are endemic to Afghanistan and there is a seasonal increase from July to September. Most of the vulnerability to waterborne diseases comes from contaminated water sources, as only 23 per cent of Afghans have access to safe drinking water.
Source: United Nations
The World Health Organization (WHO) and the Ministry of Public Health (MoPH) initiated a response immediately after the outbreak began on 9 August in the Nowa district of Ghazni province.
"Early detection of diseases is tantamount to saving lives," said Peter Graaff, WHO's Representative in Afghanistan.
"Thanks to a strong disease surveillance system and close collaboration between the MoPH, UN agencies and health NGOs [non-governmental organizations] we were quickly able to limit the magnitude of the outbreak and save lives."
Afghanistan's disease early warning system (DEWS) is now operational in all 34 provinces, and includes more than 300 surveillance officers, who help to detect and respond to disease outbreaks within 48 hours.
"In 2009 alone, we were able to rapidly respond to and control 35 cholera outbreaks and treated 1,721 reported cases across 15 provinces," said WHO epidemiologist Rashida Bano.
Cholera is an acute intestinal infection picked up through contaminated food or water. It can result in diarrhoea that can lead to severe dehydration and even death without prompt treatment.
WHO donated life-saving supplies, including cholera kits and other emergency medical supplies in the wake of the outbreak earlier this month, which affected at least 130 people.
Mr. Graaff noted that one of the challenges with regard to cholera control in Afghanistan is the insecurity in parts of the country which make it difficult to carry out timely investigations and responses.
Due to security concerns involving health ministry and UN staff, WHO said that three local NGO staff members were trained in outbreak investigation, including sample collection and treatment.
WHO added that diarrhoeal diseases are endemic to Afghanistan and there is a seasonal increase from July to September. Most of the vulnerability to waterborne diseases comes from contaminated water sources, as only 23 per cent of Afghans have access to safe drinking water.
Source: United Nations
Proper Treatment of Migrants in Saudi Arabia a Must Says UN
The reported deaths of five Ethiopian migrants in a deportation facility in Saudi Arabia has refocused attention on the way asylum-seekers are treated, with the United Nations refugees agency recalling its appeal last month for the kingdom's authorities to stop sending people back strife-torn to Somalia.
"These two cases were not necessarily linked, but certainly, the five deaths in detention were deplorable," Adrian Edwards, spokesperson of the UN High Commissioner for Refugees (UNHCR) told reporters in Geneva.
Asked if an investigation will be carried out with regard to the alleged deaths of the five Ethiopians earlier this week, Mr. Edwards said he believed that the "competent authorities" were looking into the matter.
He said UNHCR had no access to any detention or deportation facilities in Saudi Arabia, adding that the agency was exploring the possibility of being allowed to screen the people in those centres to ensure that those being deported were not in the category of people in need of international protection.
In its statement on 30 July, UNHCR said that in June alone, more than 1,000 Somalis were deported from Saudi Arabia, according to reports from Mogadishu, Somalia's capital. A similar number of Somalis were returned to their country in July.
Monitoring reports indicated that most deportees said they fled Somalia due to conflict, indiscriminate violence and human rights abuses, with most coming from southern and central Somalia, which includes Mogadishu.
UNCHR considers such deportations to be incompatible with agency's guidelines on international protection needs of Somali refugees and asylum-seekers. A majority of those being sent back from Saudi Arabia are women.
In its July statement, UNHCR said that many of the people who had been sent back to Somalia from Saudi Arabia had probably come through Yemen, where most of them were immediately recognized as refugees.
Source: United Nations
"These two cases were not necessarily linked, but certainly, the five deaths in detention were deplorable," Adrian Edwards, spokesperson of the UN High Commissioner for Refugees (UNHCR) told reporters in Geneva.
Asked if an investigation will be carried out with regard to the alleged deaths of the five Ethiopians earlier this week, Mr. Edwards said he believed that the "competent authorities" were looking into the matter.
He said UNHCR had no access to any detention or deportation facilities in Saudi Arabia, adding that the agency was exploring the possibility of being allowed to screen the people in those centres to ensure that those being deported were not in the category of people in need of international protection.
In its statement on 30 July, UNHCR said that in June alone, more than 1,000 Somalis were deported from Saudi Arabia, according to reports from Mogadishu, Somalia's capital. A similar number of Somalis were returned to their country in July.
Monitoring reports indicated that most deportees said they fled Somalia due to conflict, indiscriminate violence and human rights abuses, with most coming from southern and central Somalia, which includes Mogadishu.
UNCHR considers such deportations to be incompatible with agency's guidelines on international protection needs of Somali refugees and asylum-seekers. A majority of those being sent back from Saudi Arabia are women.
In its July statement, UNHCR said that many of the people who had been sent back to Somalia from Saudi Arabia had probably come through Yemen, where most of them were immediately recognized as refugees.
Source: United Nations
Bristol-Myers Squibb and Pfizer Inc Evaluate Unmet Need in Patients with Atrial Fibrillation
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the "Hot Line" session on August 31, 2010, in Stockholm, Sweden.
Atrial fibrillation (AF) is the most common serious chronic arrhythmia, affecting about 4.5 million people in Europe and 2.2 million people in the United States.(1) Patients with AF are at five times greater risk for stroke compared with the general population.(2) Fifteen percent of all strokes are attributable to AF, and one quarter of all strokes in persons older than 80 years are attributable to AF.(1)
In addition to treatments for heart rate and rhythm, treatment guidelines recommend that AF patients at moderate to high risk of stroke receive anticoagulation therapy with a vitamin K antagonist (VKA), such as warfarin.(1) However, surveys of practice patterns in developed countries demonstrate that 40 percent to 50 percent of patients with AF who are at moderate or high risk for stroke do not receive VKA.(1) The most common reason for not treating AF patients with a VKA appears to be concern about bleeding.(1) Difficulties managing and maintaining therapeutic warfarin dosing, as well as the use of other prescription drugs that interfere with warfarin therapy are additional concerns.(1) Currently, guidelines for the management of patients with AF recommend the use of aspirin for those who cannot take oral anticoagulants.(3)
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.
Atrial fibrillation (AF) is the most common serious chronic arrhythmia, affecting about 4.5 million people in Europe and 2.2 million people in the United States.(1) Patients with AF are at five times greater risk for stroke compared with the general population.(2) Fifteen percent of all strokes are attributable to AF, and one quarter of all strokes in persons older than 80 years are attributable to AF.(1)
In addition to treatments for heart rate and rhythm, treatment guidelines recommend that AF patients at moderate to high risk of stroke receive anticoagulation therapy with a vitamin K antagonist (VKA), such as warfarin.(1) However, surveys of practice patterns in developed countries demonstrate that 40 percent to 50 percent of patients with AF who are at moderate or high risk for stroke do not receive VKA.(1) The most common reason for not treating AF patients with a VKA appears to be concern about bleeding.(1) Difficulties managing and maintaining therapeutic warfarin dosing, as well as the use of other prescription drugs that interfere with warfarin therapy are additional concerns.(1) Currently, guidelines for the management of patients with AF recommend the use of aspirin for those who cannot take oral anticoagulants.(3)
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.
A new era for patients with atrial fibrillation - Dabigatran etexilate at the forefront
The European Society of Cardiology (ESC) issued revised practice guidelines for the management of atrial fibrillation (AF), including guidance on the role of a novel oral treatment, dabigatran etexilate, for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). At the same time, Boehringer Ingelheim confirms that the U.S. Food and Drug Administration (FDA) granted a priority review designation for Boehringer Ingelheim's novel oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in AF. A priority review designation is given to new drugs that are expected to offer major advances in treatment, or provide a treatment where no adequate therapy exists. An FDA advisory committee will meet on Monday, September 20th, to review and discuss dabigatran etexilate data.
In addition to the US, the registration process for dabigatran etexilate is underway in Europe, Japan and other countries. The company expects to receive a marketing authorization for dabigatran etexilate in first countries by end of 2010 or beginning of 2011.
RE-LY® study
All applications, including the FDA New Drug Application (NDA) are based on the results of the pivotal Phase III RE-LY® study (Randomized Evaluation of Long-term anticoagulant therapY), published in the New England Journal of Medicine in August 2009, comparing the efficacy and safety of two doses of dabigatran etexilate with warfarin (titrated to INR 2.0 to 3.0) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.(1)
Results from RE-LY ®, the largest AF study completed to date, showed that in patients with AF, dabigatran etexilate 150mg b.i.d. significantly reduced the risk of stroke and systemic embolism by 34% compared to warfarin, with comparable rates of major bleeding. Dabigatran etexilate 110mg b.i.d. demonstrated similar reductions in stroke and systemic embolism while delivering a reduction in major bleeding rates compared to warfarin. Additionally, both doses showed a significant reduction in haemorrhagic stroke and a significant reduction in life threatening, intracranial and total bleeding compared to warfarin.(1)
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim said, "Boehringer Ingelheim has a long term commitment to the treatment and prevention of stroke. The decision by the US FDA to grant a priority designation review is an important step in making dabigatran etexilate available for patients with atrial fibrillation to prevent them from strokes."
New practice guidelines on atrial fibrillation
Gregory Lip, Professor of cardiovascular medicine at University of Birmingham Centre for Cardiovascular Sciences, UK and a member of the Task Force writing group for the new ESC Guidelines for the management of atrial fibrillation commented, "The updated guidelines reflect the high need for novel treatments in the prevention of atrial-fibrillation related stroke. Both the personal and economic burden of AF-related stroke is high. Consideration of new prevention therapies will improve the overall standard of care."
Limitations of current therapy
Well-controlled vitamin K antagonist (VKA) therapy (warfarin), currently used for the prevention of stroke in atrial fibrillation, is highly effective in reducing the risk of stroke by approximately two-thirds(2), but is associated with an increased risk of bleeding as well as several limitations. Drug-drug and food interactions as well as the requirement for frequent monitoring result in only about 50% of eligible patients receiving VKA therapy(3) with fewer than half of these controlled within the therapeutic INR range.(4)
Stroke is more likely to be severe and fatal in patients with AF, and those who survive face persistent neurological deficits, persistent disability and poorer functional performance.(5,6)
According to Professor Jonas Oldgren, Associate Professor of Cardiology, Uppsala Clinical Research Centre (which furthermore was one of the coordinating centres in RE-LY®), "Dabigatran etexilate is the first treatment to significantly reduce stroke in patients with atrial fibrillation across all risk groups, when compared to well-controlled warfarin. This novel direct thrombin inhibitor could represent a very important advance in the prevention of stroke in patients with AF for both healthcare professionals and patients alike."
Dr. Oldgren referred to a sub-group analysis presented at this year's American College of Cardiology's annual congress in March, which assessed the rate of stroke and systemic embolism in patients defined as being at low, moderate or high risk of such events by the validated stroke risk stratification score, CHADS 2. The results of this analysis showed that dabigatran etexilate 150mg significantly reduced the number of strokes in patients with AF, irrespective of a patient’s risk profile. Dabigatran etexilate 110mg b.i.d. was associated with significantly lower major bleeding events and both dabigatran doses showed significantly lower intracranial bleeding rates when compared to well-controlled warfarin.(7)
RE-LY® is the largest AF study ever completed (18,113 patients) investigating dabigatran etexilate vs. well controlled warfarin. RE-LY® included patients with at least one risk factor of stroke, representative of a real-world setting. In addition, 50% of enrolled patients were naïve to previous oral anticoagulants, a population who may reflect a more realistic experience with anticoagulants, as they are more likely to represent the patient group with the highest percentages outside of the therapeutic INR range.(1,8)
Up to three million people worldwide suffer strokes related to AF each year,(9-11) which tend to be especially severe and disabling,(10) with half of people dying within one year.(12) Therefore, there is an clear medical need for an effective and safe anticoagulant, without the multiple limitations of VKA therapy.
About RE-LY®
RE-LY® (Randomized Evaluation of Long term anticoagulant therapy) was a global, phase III, randomized trial of 18,113 patients enrolled in over 900 centres in 44 countries, investigating whether dabigatran etexilate (2 blinded doses) is as effective as well controlled warfarin with target INR of 2.0-3.0 for stroke prevention. Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.
The primary endpoint of the trial was incidence of stroke (including haemorrhagic) or systemic embolism. Secondary outcome measures included all-cause death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).
Compared to well controlled warfarin, dabigatran etexilate showed in the trial:(1)
* Significant reduction in the risk of stroke and systemic embolism – including haemorrhagic strokes with dabigatran etexilate 150 mg bid
* Significantly lower major bleeding events with dabigatran etexilate 110 mg bid
* Significantly lower life threatening and intracranial bleeding with both doses
* Significant reduction in vascular mortality with dabigatran etexilate 150 mg bid.
About AF and stroke
AF is the most common heart rhythm condition, affecting around 1% of the total population, rising to 10% in people over the age of 80.(13) A total of 6.3 million people in the US, Japan, Germany, Italy, France, UK and Spain were living with AF in 2007 and this is expected to increase to 7.5 million by 2017 primarily due to the ageing population.(14) People with AF are at increased risk of blood clots, which raises stroke risk by five times.(15,16) Up to 3 million people worldwide suffer strokes related to AF each year. 10-12 Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%), with resultant societal costs and burden to the healthcare system.(9) AF alone is associated with a cost of up to €13.5 billion across the European Union. 15 Warfarin is the current standard of care for reducing stroke in patients with AF. It is highly effective when patients blood clotting value is maintained within the narrow therapeutic INR range of 2.0-3.0 as in a clinical trial setting. 17 However in clinical practice, due to the well-known limitations with warfarin only 51% of diagnosed patients with AF at risk of stroke receive warfarin(3) and fewer than half of these are controlled within the narrow therapeutic range.(4)
About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs) (18) targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.
Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
Dabigatran etexilate has already been approved in 75 countries under the trademark Pradaxa® for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.
About the dabigatran etexilate clinical trial programme
Boehringer Ingelheim's clinical trial program to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:
* Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgeries
* Treatment of acute VTE
* Secondary prevention of VTE
* Secondary prevention of cardiac events in patients with acute coronary syndrome (ACS)
* Stroke prevention in atrial fibrillation (AF).
In addition to the US, the registration process for dabigatran etexilate is underway in Europe, Japan and other countries. The company expects to receive a marketing authorization for dabigatran etexilate in first countries by end of 2010 or beginning of 2011.
RE-LY® study
All applications, including the FDA New Drug Application (NDA) are based on the results of the pivotal Phase III RE-LY® study (Randomized Evaluation of Long-term anticoagulant therapY), published in the New England Journal of Medicine in August 2009, comparing the efficacy and safety of two doses of dabigatran etexilate with warfarin (titrated to INR 2.0 to 3.0) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.(1)
Results from RE-LY ®, the largest AF study completed to date, showed that in patients with AF, dabigatran etexilate 150mg b.i.d. significantly reduced the risk of stroke and systemic embolism by 34% compared to warfarin, with comparable rates of major bleeding. Dabigatran etexilate 110mg b.i.d. demonstrated similar reductions in stroke and systemic embolism while delivering a reduction in major bleeding rates compared to warfarin. Additionally, both doses showed a significant reduction in haemorrhagic stroke and a significant reduction in life threatening, intracranial and total bleeding compared to warfarin.(1)
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim said, "Boehringer Ingelheim has a long term commitment to the treatment and prevention of stroke. The decision by the US FDA to grant a priority designation review is an important step in making dabigatran etexilate available for patients with atrial fibrillation to prevent them from strokes."
New practice guidelines on atrial fibrillation
Gregory Lip, Professor of cardiovascular medicine at University of Birmingham Centre for Cardiovascular Sciences, UK and a member of the Task Force writing group for the new ESC Guidelines for the management of atrial fibrillation commented, "The updated guidelines reflect the high need for novel treatments in the prevention of atrial-fibrillation related stroke. Both the personal and economic burden of AF-related stroke is high. Consideration of new prevention therapies will improve the overall standard of care."
Limitations of current therapy
Well-controlled vitamin K antagonist (VKA) therapy (warfarin), currently used for the prevention of stroke in atrial fibrillation, is highly effective in reducing the risk of stroke by approximately two-thirds(2), but is associated with an increased risk of bleeding as well as several limitations. Drug-drug and food interactions as well as the requirement for frequent monitoring result in only about 50% of eligible patients receiving VKA therapy(3) with fewer than half of these controlled within the therapeutic INR range.(4)
Stroke is more likely to be severe and fatal in patients with AF, and those who survive face persistent neurological deficits, persistent disability and poorer functional performance.(5,6)
According to Professor Jonas Oldgren, Associate Professor of Cardiology, Uppsala Clinical Research Centre (which furthermore was one of the coordinating centres in RE-LY®), "Dabigatran etexilate is the first treatment to significantly reduce stroke in patients with atrial fibrillation across all risk groups, when compared to well-controlled warfarin. This novel direct thrombin inhibitor could represent a very important advance in the prevention of stroke in patients with AF for both healthcare professionals and patients alike."
Dr. Oldgren referred to a sub-group analysis presented at this year's American College of Cardiology's annual congress in March, which assessed the rate of stroke and systemic embolism in patients defined as being at low, moderate or high risk of such events by the validated stroke risk stratification score, CHADS 2. The results of this analysis showed that dabigatran etexilate 150mg significantly reduced the number of strokes in patients with AF, irrespective of a patient’s risk profile. Dabigatran etexilate 110mg b.i.d. was associated with significantly lower major bleeding events and both dabigatran doses showed significantly lower intracranial bleeding rates when compared to well-controlled warfarin.(7)
RE-LY® is the largest AF study ever completed (18,113 patients) investigating dabigatran etexilate vs. well controlled warfarin. RE-LY® included patients with at least one risk factor of stroke, representative of a real-world setting. In addition, 50% of enrolled patients were naïve to previous oral anticoagulants, a population who may reflect a more realistic experience with anticoagulants, as they are more likely to represent the patient group with the highest percentages outside of the therapeutic INR range.(1,8)
Up to three million people worldwide suffer strokes related to AF each year,(9-11) which tend to be especially severe and disabling,(10) with half of people dying within one year.(12) Therefore, there is an clear medical need for an effective and safe anticoagulant, without the multiple limitations of VKA therapy.
About RE-LY®
RE-LY® (Randomized Evaluation of Long term anticoagulant therapy) was a global, phase III, randomized trial of 18,113 patients enrolled in over 900 centres in 44 countries, investigating whether dabigatran etexilate (2 blinded doses) is as effective as well controlled warfarin with target INR of 2.0-3.0 for stroke prevention. Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.
The primary endpoint of the trial was incidence of stroke (including haemorrhagic) or systemic embolism. Secondary outcome measures included all-cause death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).
Compared to well controlled warfarin, dabigatran etexilate showed in the trial:(1)
* Significant reduction in the risk of stroke and systemic embolism – including haemorrhagic strokes with dabigatran etexilate 150 mg bid
* Significantly lower major bleeding events with dabigatran etexilate 110 mg bid
* Significantly lower life threatening and intracranial bleeding with both doses
* Significant reduction in vascular mortality with dabigatran etexilate 150 mg bid.
About AF and stroke
AF is the most common heart rhythm condition, affecting around 1% of the total population, rising to 10% in people over the age of 80.(13) A total of 6.3 million people in the US, Japan, Germany, Italy, France, UK and Spain were living with AF in 2007 and this is expected to increase to 7.5 million by 2017 primarily due to the ageing population.(14) People with AF are at increased risk of blood clots, which raises stroke risk by five times.(15,16) Up to 3 million people worldwide suffer strokes related to AF each year. 10-12 Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%), with resultant societal costs and burden to the healthcare system.(9) AF alone is associated with a cost of up to €13.5 billion across the European Union. 15 Warfarin is the current standard of care for reducing stroke in patients with AF. It is highly effective when patients blood clotting value is maintained within the narrow therapeutic INR range of 2.0-3.0 as in a clinical trial setting. 17 However in clinical practice, due to the well-known limitations with warfarin only 51% of diagnosed patients with AF at risk of stroke receive warfarin(3) and fewer than half of these are controlled within the narrow therapeutic range.(4)
About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs) (18) targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.
Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
Dabigatran etexilate has already been approved in 75 countries under the trademark Pradaxa® for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.
About the dabigatran etexilate clinical trial programme
Boehringer Ingelheim's clinical trial program to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:
* Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgeries
* Treatment of acute VTE
* Secondary prevention of VTE
* Secondary prevention of cardiac events in patients with acute coronary syndrome (ACS)
* Stroke prevention in atrial fibrillation (AF).
Monday, August 30, 2010
Novartis drug Tasigna® approved in Switzerland after fast-track review for treatment of patients with newly diagnosed Ph+ CML
The Swiss health authority Swissmedic has granted approval for Tasigna® (nilotinib) 300 mg twice daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna is the first new therapeutic option for newly diagnosed patients since the introduction of Glivec® (imatinib)*, providing a major advance for patients with this blood cancer.
The approval of Tasigna came after being designated for a fast track review by Swissmedic based on positive findings at 12 months from a pivotal Phase III trial, ENESTnd, demonstrating superiority to the standard of care Glivec in achieving molecular and cytogenetic response and delaying cancer progression. In June of this year, these findings were published in The New England Journal of Medicine[1] and 18-month median data were presented at the 2010 annual meeting of the American Society of Clinical Oncology.
The US Food and Drug Administration approved Tasigna in the first-line indication in June. Other regulatory submissions are under review worldwide.
"Switzerland was the first country to approve Tasigna in 2007 for its original indication as a second-line treatment after Glivec. Now, with this approval of Tasigna as a first-line treatment, we are pleased to offer newly diagnosed CML patients a new and even more effective option for delaying disease progression," said Hervé Hoppenot, President, Novartis Oncology.
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML[2,3]. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec[4].
In its pivotal head-to-head trial, Tasigna surpassed Glivec in key measures of treatment efficacy, as has been previously reported. Tasigna eliminated Bcr-Abl faster than Glivec, resulting in lower rates of cancer progression even after only 12 months of therapy[1]. Deep reduction of Bcr-Abl, known as a major molecular response, is considered to be an important therapeutic milestone associated with good long-term outcomes for patients with Ph+ CML[5-7]. Treatment with Tasigna led to higher rates of both major molecular response and complete cytogenetic response (elimination of the Philadelphia chromosome that is the hallmark of the cancer) compared with Glivec[1] at 12 months.
The randomized, open-label, multicenter ENESTnd trial (also known as Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) compared the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase[1]. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase.
At 12 months, two patients on the nilotinib arm progressed to either accelerated phase or blast crisis while 11 patients on the imatinib arm progressed to either accelerated phase or blast crisis. In the study, Tasigna was well tolerated. Fewer patients discontinued due to adverse events from the Tasigna 300 mg twice daily arm of the study compared to the Glivec 400 mg once daily arm. The ENESTnd trial is ongoing.
The approval of Tasigna came after being designated for a fast track review by Swissmedic based on positive findings at 12 months from a pivotal Phase III trial, ENESTnd, demonstrating superiority to the standard of care Glivec in achieving molecular and cytogenetic response and delaying cancer progression. In June of this year, these findings were published in The New England Journal of Medicine[1] and 18-month median data were presented at the 2010 annual meeting of the American Society of Clinical Oncology.
The US Food and Drug Administration approved Tasigna in the first-line indication in June. Other regulatory submissions are under review worldwide.
"Switzerland was the first country to approve Tasigna in 2007 for its original indication as a second-line treatment after Glivec. Now, with this approval of Tasigna as a first-line treatment, we are pleased to offer newly diagnosed CML patients a new and even more effective option for delaying disease progression," said Hervé Hoppenot, President, Novartis Oncology.
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML[2,3]. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Glivec[4].
In its pivotal head-to-head trial, Tasigna surpassed Glivec in key measures of treatment efficacy, as has been previously reported. Tasigna eliminated Bcr-Abl faster than Glivec, resulting in lower rates of cancer progression even after only 12 months of therapy[1]. Deep reduction of Bcr-Abl, known as a major molecular response, is considered to be an important therapeutic milestone associated with good long-term outcomes for patients with Ph+ CML[5-7]. Treatment with Tasigna led to higher rates of both major molecular response and complete cytogenetic response (elimination of the Philadelphia chromosome that is the hallmark of the cancer) compared with Glivec[1] at 12 months.
The randomized, open-label, multicenter ENESTnd trial (also known as Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) compared the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase[1]. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase.
At 12 months, two patients on the nilotinib arm progressed to either accelerated phase or blast crisis while 11 patients on the imatinib arm progressed to either accelerated phase or blast crisis. In the study, Tasigna was well tolerated. Fewer patients discontinued due to adverse events from the Tasigna 300 mg twice daily arm of the study compared to the Glivec 400 mg once daily arm. The ENESTnd trial is ongoing.
NICE Snub to Glivec, a Rare Cancer Drug
The National Institute for Health and Clinical Excellence (Nice), a health supervisory body, has stated that the cancer drug, Glivec (imatinib), recommended for treating gastrointestinal stromal tumours (GIST) would no longer be used on NHS, as it failed to possess evidences regarding its long-term effectiveness.
In the UK, every year 900 people get affected with GSIT lying within the ages 50 and 60. Glivec is prescribed for such patients who cannot be treated with surgery.
Nice reviewed the use of the said drug for patients whose tumour has been removed and for those who have chances of getting affected by tumour again. No significant results came up and Glivec didn’t show any solid evidences of prolonging life. It didn’t even determine a specific time-frame for which it should be taken. It was also found out that the drug is ineffective if it is used after the recurrence of the cancer.
The drug would face another appraisal in 2011, when more evidences will get revealed.
"At around £19,500 per patient per year, this is an expensive drug, and we need to be more confident about how well it works and what its side-effects are before we consider recommending it for use in the NHS”, said Andrew Dillon, Chief Executive of Nice.
Earlier, Nice also refused the use of drug Avastin for people with later stage of bowel cancer, which increases patients’ life by six weeks if given along with chemotherapy and costs £21,000 per patient.
In the UK, every year 900 people get affected with GSIT lying within the ages 50 and 60. Glivec is prescribed for such patients who cannot be treated with surgery.
Nice reviewed the use of the said drug for patients whose tumour has been removed and for those who have chances of getting affected by tumour again. No significant results came up and Glivec didn’t show any solid evidences of prolonging life. It didn’t even determine a specific time-frame for which it should be taken. It was also found out that the drug is ineffective if it is used after the recurrence of the cancer.
The drug would face another appraisal in 2011, when more evidences will get revealed.
"At around £19,500 per patient per year, this is an expensive drug, and we need to be more confident about how well it works and what its side-effects are before we consider recommending it for use in the NHS”, said Andrew Dillon, Chief Executive of Nice.
Earlier, Nice also refused the use of drug Avastin for people with later stage of bowel cancer, which increases patients’ life by six weeks if given along with chemotherapy and costs £21,000 per patient.
Walking Enhances Brain Function: Study
Even moderate exercise
- like walking - can enhance the connectivity of important brain circuits, combat declines in brain function associated with aging and increase performance on cognitive tasks, say researchers.
In the study, researchers found that moderate walking three times per week for a year increased brain connectivity and brain function in older adults.
The study followed 65 adults, aged 59 to 80, who joined a walking group or stretching and toning group for a year.
All of the participants were sedentary before the study, reporting less than two episodes of physical activity lasting 30 minutes or more in the previous six months. The researchers also measured brain activity in 32 younger (18- to 35-year-old) adults.
Rather than focusing on specific brain structures, the study looked at activity in brain regions that function together as networks.
"Almost nothing in the brain gets done by one area - it's more of a circuit," said University of Illinois psychology professor and Beckman Institute Director Art Kramer, who led the study with kinesiology and community health professor Edward McAuley and doctoral student Michelle Voss.
"These networks can become more or less connected. In general, as we get older, they become less connected, so we were interested in the effects of fitness on connectivity of brain networks that show the most dysfunction with age."
Neuroscientists have identified several distinct brain circuits. Perhaps the most intriguing is the default mode network (DMN), which dominates brain activity when a person is least engaged with the outside world - either passively observing something or simply daydreaming.
- like walking - can enhance the connectivity of important brain circuits, combat declines in brain function associated with aging and increase performance on cognitive tasks, say researchers.
In the study, researchers found that moderate walking three times per week for a year increased brain connectivity and brain function in older adults.
The study followed 65 adults, aged 59 to 80, who joined a walking group or stretching and toning group for a year.
All of the participants were sedentary before the study, reporting less than two episodes of physical activity lasting 30 minutes or more in the previous six months. The researchers also measured brain activity in 32 younger (18- to 35-year-old) adults.
Rather than focusing on specific brain structures, the study looked at activity in brain regions that function together as networks.
"Almost nothing in the brain gets done by one area - it's more of a circuit," said University of Illinois psychology professor and Beckman Institute Director Art Kramer, who led the study with kinesiology and community health professor Edward McAuley and doctoral student Michelle Voss.
"These networks can become more or less connected. In general, as we get older, they become less connected, so we were interested in the effects of fitness on connectivity of brain networks that show the most dysfunction with age."
Neuroscientists have identified several distinct brain circuits. Perhaps the most intriguing is the default mode network (DMN), which dominates brain activity when a person is least engaged with the outside world - either passively observing something or simply daydreaming.
Cost of Vaccines
Vaccines are non-scheduled drugs and not covered under the price control category of drugs under the provisions of Drugs (Prices Control) Oder, 1995 (DPCO, 95). The manufacturers fix the prices by themselves without seeking the approval of National Pharmaceutical Pricing Authority (NPPA). However, NPPA, as a part of price monitoring activity, regularly examines the movement in prices of non-scheduled formulations. The monthly reports of ORG IMS and the information furnished by individual manufacturers are utilized for the purpose of monitoring prices of non-scheduled formulations. Wherever a price increase beyond 10% per annum (20% before 01.04.2007) is noticed, the manufacturer is asked to bring down the price voluntarily failing which, subject to prescribed conditions action is initiated under paragraph 10(b) of the DPCO, 1995 for fixing the price of the formulation in public interest. This is an ongoing process.
Thursday, August 26, 2010
CGHS-Apollo Dialysis Center to be a Precursor of Standalone Dialysis Units First of its kind PPP Initiative to be Inaugurated tomorrow
In a pioneering initiative and first of its kind in Central Government Health Scheme(CGHS), Minister of Health and Family Welfare Shri Ghulam Nabi Azad will inaugurate a standalone haemodialysis centre at Sadiq Nagar CGHS Wellness centre, here tomorrow. This pilot project shall be a testing pad in CGHS before such units are rolled out at District Level under the National Program for control of Diabetes. This is being started as a pilot project in collaboration with M/S Alliance Medicorp (India) Limited, Chennai a JV company of Apollo Health and Lifestyle Ltd. (Apollo Group of Hospitals) under Public Private partnership. Secretary (Health) Ms K Sujatha Rao, Director General Health Services Dr R K Shrivastava and Chairman Apollo group Sh Pratap Chander Reddy will be present on the occasion.
Currently in India dialysis units are set up within hospitals mainly due to shortage of nephrologists leading to scarcity of dialysis units. CGHS beneficiaries often suffer hardship for dialysis as demand far exceeds the supply. CGHS refers quite a few of its beneficiaries to private empanelled hospitals. In Delhi around 40 – 50 patients require dialysis per day. Further in years to come, need for dialysis is likely to go up in view of prevalent diseases like diabetes and hypertension which lead to chronic Kidney disease and renal failure. Therefore Public Health sector shall have to cater to significantly increased demand for dialysis and concept of standalone dialysis has been looked into for meeting this demand. In this model dialysis unit is not located in a hospital and therefore eliminating the need of availability of Nephrologist round the clock as Dialysis station is manned by trained medical and paramedical staff under the overall supervision of Nephrologists who ensure quality control as per laid down protocol. Without exploring the possibility of commissioning standalone dialysis units it may never be possible to meet this demand . While identifying a private partner Apollo Hospitals scored better in overall support mechanism of Nephrologist, Human Resources, Referral, Complications Management, Performance Report and Grievance Redressal. Chronic renal failure is a disease where patient’s kidneys are either compromised or stop functioning and are unable to clear toxic wastes from the body. Dialysis is regarded as a "holding measure" until a renal transplant can be performed, or sometimes as the only lifelong supportive measure in those for whom a transplant would be inappropriate.
A space of 2400 sq. ft. covered area has been renovated to suit the requirements for providing state of art dialysis facility .It shall have a capacity to dialyze up to 21 cases of Chronic Renal Failure per day with seven functional Dialysis machines (and an additional stand by machine) and shall be operational from 7 A.M. to 8 P.M. for 310 days in a year. If maximally utilized it shall be able to undertake 6510 dialysis per year.
Dialysis machine works on the principle of the diffusion (Waste removal) of solutes and ultra filtration(Fluid Removal) across a semi permeable membrane .a thin layer of material that contains various sized holes, or pores through which smaller solutes and fluid pass through but blood cells, and large proteins can’t). Substances in water tend to move from an area of high concentration to an area of low concentration Blood flows by one side of a semi-permeable membrane, and a dialysate (dialysis fluid), flows by the opposite side .this counter current being beneficial for removal of urea and creatinine accumulation of which in blood are life threatening.
This joint venture would fruitfully cater to the need of maintenance haemodialysis of CGHS beneficiaries by in house management of such patients. This center would be extremely beneficial to CGHS patients of chronic renal failure by providing timely haemodialysis and mitigate suffering thereby improving the quality of life and productivity. This center shall also reduce dependence of CGHS on private empanelled hospitals and government hospitals.
Currently in India dialysis units are set up within hospitals mainly due to shortage of nephrologists leading to scarcity of dialysis units. CGHS beneficiaries often suffer hardship for dialysis as demand far exceeds the supply. CGHS refers quite a few of its beneficiaries to private empanelled hospitals. In Delhi around 40 – 50 patients require dialysis per day. Further in years to come, need for dialysis is likely to go up in view of prevalent diseases like diabetes and hypertension which lead to chronic Kidney disease and renal failure. Therefore Public Health sector shall have to cater to significantly increased demand for dialysis and concept of standalone dialysis has been looked into for meeting this demand. In this model dialysis unit is not located in a hospital and therefore eliminating the need of availability of Nephrologist round the clock as Dialysis station is manned by trained medical and paramedical staff under the overall supervision of Nephrologists who ensure quality control as per laid down protocol. Without exploring the possibility of commissioning standalone dialysis units it may never be possible to meet this demand . While identifying a private partner Apollo Hospitals scored better in overall support mechanism of Nephrologist, Human Resources, Referral, Complications Management, Performance Report and Grievance Redressal. Chronic renal failure is a disease where patient’s kidneys are either compromised or stop functioning and are unable to clear toxic wastes from the body. Dialysis is regarded as a "holding measure" until a renal transplant can be performed, or sometimes as the only lifelong supportive measure in those for whom a transplant would be inappropriate.
A space of 2400 sq. ft. covered area has been renovated to suit the requirements for providing state of art dialysis facility .It shall have a capacity to dialyze up to 21 cases of Chronic Renal Failure per day with seven functional Dialysis machines (and an additional stand by machine) and shall be operational from 7 A.M. to 8 P.M. for 310 days in a year. If maximally utilized it shall be able to undertake 6510 dialysis per year.
Dialysis machine works on the principle of the diffusion (Waste removal) of solutes and ultra filtration(Fluid Removal) across a semi permeable membrane .a thin layer of material that contains various sized holes, or pores through which smaller solutes and fluid pass through but blood cells, and large proteins can’t). Substances in water tend to move from an area of high concentration to an area of low concentration Blood flows by one side of a semi-permeable membrane, and a dialysate (dialysis fluid), flows by the opposite side .this counter current being beneficial for removal of urea and creatinine accumulation of which in blood are life threatening.
This joint venture would fruitfully cater to the need of maintenance haemodialysis of CGHS beneficiaries by in house management of such patients. This center would be extremely beneficial to CGHS patients of chronic renal failure by providing timely haemodialysis and mitigate suffering thereby improving the quality of life and productivity. This center shall also reduce dependence of CGHS on private empanelled hospitals and government hospitals.
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