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.
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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.
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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.
Sunday, September 26, 2010
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."
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