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.
Monday, August 30, 2010
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.
Sanofi-aventis and Merck appoint Raul Kohan as CEO for the new Animal Health joint venture
Sanofi-aventis and Merck & Co., Inc. announced today that Raul E. Kohan will be
appointed Chief Executive Officer of their proposed Animal Health joint venture. Sanofi-aventis and
Merck - known as MSD outside the United States and Canada - intend to combine Merial with
Intervet/Schering-Plough, to create a new global leader in Animal Health to be called Merial-Intervet.
Mr. Kohan is currently President of Intervet/Schering-Plough, Merck's Animal Health business. He
will commence his new responsibilities when the new joint venture is approved by regulatory
authorities and closes, which is expected to occur in the first quarter of 2011. The formation of this
new animal health joint venture is subject to execution of final agreements, antitrust review in the
United States, Europe and other countries, as well as other customary closing conditions.
“Raul Kohan will head this new leader in Animal Health”, said Christopher A. Viehbacher, Chief
Executive Officer of sanofi-aventis. “The talents, products and expertise of both companies are very
complementary and will create a company with greater geographical and market coverage. As a
result, we expect the new Merial-Intervet joint venture to drive significant growth”.
“Raul brings a wealth of animal health and global pharmaceutical industry experience," said Richard
T. Clark, Merck Chairman and Chief Executive Officer. “We're pleased that Raul will lead the
integration of the two companies while continuing to deliver global growth momentum. The new joint
venture will have one of the broadest portfolios of animal health products and services in
pharmaceuticals and biologics to meet the needs of millions of customers."
Raul Kohan is Executive Vice President and President, Global Animal Health, Merck. He joined
Schering-Plough in 1984 and has since held positions of increasing responsibility. He served as
Deputy Head of Animal Health and Senior Vice President, Corporate Excellence and Administrative
Services for Schering-Plough Corporation. Previously, Kohan’s responsibilities included overseeing
the company's Global Specialty Operations group, which comprised Animal Health and Consumer
Health Care for Schering-Plough. Kohan graduated from the General San Martin Military Academy,
Argentina, and holds an M.B.A. degree in economics from the University of Buenos Aires.
2
José Barella, the current Executive Chairman of Merial, will continue his role until the transaction
closes. Thus, he will work closely with Mr. Kohan and will contribute significantly to the transition and
creation of the new combined Animal Health business. Mr. Barella joined Merial in 2001 and became
Chief Operating Officer in 2005 and head of business operations with responsibilities for all
commercial activities for Merial globally, including sales and marketing for both the companion animal
and production animal businesses, and the commercial functions that support them. He was named
Merial's Executive Chairman in 2007 with responsibility for executing global strategy and through his
leadership grew the company to be an industry leader.
The new Merial-Intervet joint venture will offer a broader portfolio of animal health products and
services in pharmaceuticals and biologics, as well as, the ability to capitalize on growth opportunities
in all fields and countries around the world.
The worldwide animal health market reached $19 billion in 2008. Products for companion animals
accounted for 40 percent of total sales while products for production animals accounted for the
remaining 60 percent of total sales. This market is expected to grow at around 5 percent per year
over the next 5 years, driven by a growing demand for animal proteins, as well as a strong consumer
needs for companion animal health care.
Merial and Intervet/Schering-Plough will continue to operate independently until the closing of the tranction.
appointed Chief Executive Officer of their proposed Animal Health joint venture. Sanofi-aventis and
Merck - known as MSD outside the United States and Canada - intend to combine Merial with
Intervet/Schering-Plough, to create a new global leader in Animal Health to be called Merial-Intervet.
Mr. Kohan is currently President of Intervet/Schering-Plough, Merck's Animal Health business. He
will commence his new responsibilities when the new joint venture is approved by regulatory
authorities and closes, which is expected to occur in the first quarter of 2011. The formation of this
new animal health joint venture is subject to execution of final agreements, antitrust review in the
United States, Europe and other countries, as well as other customary closing conditions.
“Raul Kohan will head this new leader in Animal Health”, said Christopher A. Viehbacher, Chief
Executive Officer of sanofi-aventis. “The talents, products and expertise of both companies are very
complementary and will create a company with greater geographical and market coverage. As a
result, we expect the new Merial-Intervet joint venture to drive significant growth”.
“Raul brings a wealth of animal health and global pharmaceutical industry experience," said Richard
T. Clark, Merck Chairman and Chief Executive Officer. “We're pleased that Raul will lead the
integration of the two companies while continuing to deliver global growth momentum. The new joint
venture will have one of the broadest portfolios of animal health products and services in
pharmaceuticals and biologics to meet the needs of millions of customers."
Raul Kohan is Executive Vice President and President, Global Animal Health, Merck. He joined
Schering-Plough in 1984 and has since held positions of increasing responsibility. He served as
Deputy Head of Animal Health and Senior Vice President, Corporate Excellence and Administrative
Services for Schering-Plough Corporation. Previously, Kohan’s responsibilities included overseeing
the company's Global Specialty Operations group, which comprised Animal Health and Consumer
Health Care for Schering-Plough. Kohan graduated from the General San Martin Military Academy,
Argentina, and holds an M.B.A. degree in economics from the University of Buenos Aires.
2
José Barella, the current Executive Chairman of Merial, will continue his role until the transaction
closes. Thus, he will work closely with Mr. Kohan and will contribute significantly to the transition and
creation of the new combined Animal Health business. Mr. Barella joined Merial in 2001 and became
Chief Operating Officer in 2005 and head of business operations with responsibilities for all
commercial activities for Merial globally, including sales and marketing for both the companion animal
and production animal businesses, and the commercial functions that support them. He was named
Merial's Executive Chairman in 2007 with responsibility for executing global strategy and through his
leadership grew the company to be an industry leader.
The new Merial-Intervet joint venture will offer a broader portfolio of animal health products and
services in pharmaceuticals and biologics, as well as, the ability to capitalize on growth opportunities
in all fields and countries around the world.
The worldwide animal health market reached $19 billion in 2008. Products for companion animals
accounted for 40 percent of total sales while products for production animals accounted for the
remaining 60 percent of total sales. This market is expected to grow at around 5 percent per year
over the next 5 years, driven by a growing demand for animal proteins, as well as a strong consumer
needs for companion animal health care.
Merial and Intervet/Schering-Plough will continue to operate independently until the closing of the tranction.
Change in environment sparks stem cell cross-over
EU-funded scientists have discovered that stem cells from one of the immune system's main organs can be reprogrammed to form hair follicle stem cells. The key lies in altering the environment in which the cells are grown. These results demonstrate that it is possible to alter stem cells without genetic manipulation. Details of the study are published in Nature.
Ectoderm, endoderm and mesoderm are the three germ layers that develop as an embryo grows. Over time, these layers form the basis of skin and nerves (ectoderm) of the gut, liver, pancreas, thymus and other organs (endoderm), and of muscle, bones and blood (mesoderm).
Scientists have always thought that the boundaries that define these layers could not be crossed. However, results from this latest study now demonstrate that the boundaries are much more versatile, and that stem cells that switch layers can produce startling results.
The team from Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland and the University of Edinburgh in the UK has shown that cells originating in one germ layer (in this case, thymus stem cells originating from the endoderm) can be developed into cells associated with one of the other two layers (skin stem cells originating from the ectoderm).
To determine their findings, the scientists grew stem cells from the thymus - an important organ of the immune system - using the conditions required for growing hair follicle skin stem cells. They found that the transplanted cells maintained skin and hair for more than 12 months, which was significantly more than hair follicle stem cells produced under natural conditions. Gradually, the cells' genetic markers remarkably began to resemble those of hair follicle stem cells.
This means that a surrounding environment can reprogramme stem cells to generate tissues that, under normal circumstances, would not be possible. Just like stem cells from the thymus (previously thought to be less versatile than other cells), the findings suggest that the cross-over could extend to other organs. This would represent a major breakthrough in the field of organ transplantation and regeneration, and could help many people including burn victims.
Dr Clare Blackburn from the University of Edinburgh explained that it is not just that a latent capacity is triggered when these stem cells come into contact with skin, but rather they "change track - expressing different genes and becoming more potent". She added that further research could determine whether other microenvironments (beyond just skin) would produce a similar result.
This research was supported by the EU's Sixth Framework Programme (FP6) and Seventh Framework Programme (FP7) as part of the work of three projects: EUROSTEMCELL ('European consortium for stem cell research'), which received EUR 11.91 million under FP6's 'Life sciences, genomics and biotechnology for health' Thematic area; EUROSYSTEM ('European consortium for systematic stem cell biology'), which received EUR 12 million under FP7's Health Theme; and OPTISTEM ('Optimization of stem cell therapy for clinical trials of degenerative skin and muscle diseases'), which received EUR 11.99 million also under FP7's Health Theme.
* Nature, http://www.nature.com
* Ecole Polytechnique Fédérale de Lausanne (EPFL), http://www.epfl.ch
* University of Edinburgh, http://www.ed.ac.uk
Ectoderm, endoderm and mesoderm are the three germ layers that develop as an embryo grows. Over time, these layers form the basis of skin and nerves (ectoderm) of the gut, liver, pancreas, thymus and other organs (endoderm), and of muscle, bones and blood (mesoderm).
Scientists have always thought that the boundaries that define these layers could not be crossed. However, results from this latest study now demonstrate that the boundaries are much more versatile, and that stem cells that switch layers can produce startling results.
The team from Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland and the University of Edinburgh in the UK has shown that cells originating in one germ layer (in this case, thymus stem cells originating from the endoderm) can be developed into cells associated with one of the other two layers (skin stem cells originating from the ectoderm).
To determine their findings, the scientists grew stem cells from the thymus - an important organ of the immune system - using the conditions required for growing hair follicle skin stem cells. They found that the transplanted cells maintained skin and hair for more than 12 months, which was significantly more than hair follicle stem cells produced under natural conditions. Gradually, the cells' genetic markers remarkably began to resemble those of hair follicle stem cells.
This means that a surrounding environment can reprogramme stem cells to generate tissues that, under normal circumstances, would not be possible. Just like stem cells from the thymus (previously thought to be less versatile than other cells), the findings suggest that the cross-over could extend to other organs. This would represent a major breakthrough in the field of organ transplantation and regeneration, and could help many people including burn victims.
Dr Clare Blackburn from the University of Edinburgh explained that it is not just that a latent capacity is triggered when these stem cells come into contact with skin, but rather they "change track - expressing different genes and becoming more potent". She added that further research could determine whether other microenvironments (beyond just skin) would produce a similar result.
This research was supported by the EU's Sixth Framework Programme (FP6) and Seventh Framework Programme (FP7) as part of the work of three projects: EUROSTEMCELL ('European consortium for stem cell research'), which received EUR 11.91 million under FP6's 'Life sciences, genomics and biotechnology for health' Thematic area; EUROSYSTEM ('European consortium for systematic stem cell biology'), which received EUR 12 million under FP7's Health Theme; and OPTISTEM ('Optimization of stem cell therapy for clinical trials of degenerative skin and muscle diseases'), which received EUR 11.99 million also under FP7's Health Theme.
* Nature, http://www.nature.com
* Ecole Polytechnique Fédérale de Lausanne (EPFL), http://www.epfl.ch
* University of Edinburgh, http://www.ed.ac.uk
Tuesday, August 24, 2010
Scientists find 95 genetic variants associated with heart disease risk factor
An international team of scientists has identified 95 genetic variants associated with high blood cholesterol and triglyceride levels which are major risk factors for coronary heart disease. The study, published in the journal Nature and funded in part by the EU, could lead to novel ways of preventing and treating heart disease.
Coronary heart disease is a leading cause of death worldwide. Abnormal levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C, or 'bad' cholesterol), high-density lipoprotein cholesterol (HDL-C) and triglycerides are all known to be major risk factors for heart disease and represent important drug targets.
In their paper, the scientists describe how they carried out a genome-wide association study (GWAS), scanning the genomes of 100,000 people of European descent and looking for changes in the genetic material that are associated with changes in lipid levels.
"Although blood concentrations of cholesterol and triglycerides have long between known as risk factors for cardiovascular disease, the extent to which genetics contributes to those concentrations and just how alterations in the underlying genes leads to the development of disease has been incredibly difficult to piece together," explained Dr Sekar Kathiresan of Massachusetts General Hospital in the US.
The researchers' analyses uncovered 95 genetic variants, 59 of which were previously unknown. According to the team, taken together the 95 variants 'explain 10%-12% of the total variance (representing 25%-30% of the genetic variance'.
Many of the variants are located in genes known to be linked to lipid levels and heart disease. "Closer scrutiny of the gene loci revealed genetic variants which we know offer a molecular target for cholesterol-lowering drugs," commented Professor Thomas Meitinger of the German Research Center for Environmental Health.
The scientists also scanned the genomes of thousands of people of East Asian, south Asian and African American descent. This revealed that the majority of the variants are shared across diverse ethnic groups.
"The new findings point us to specific genetic signposts that allow us to understand more fully why many people from all walks of life have abnormal levels of cholesterol and other blood lipids that lead to heart disease," said Christopher O'Donnell of the National Institutes of Health (NIH) in the US. "What's really exciting about this work is that we are moving from discovery to understanding brand-new information about how genes alter the lipids that contribute to heart disease."
As well as shedding light on the genetic causes of abnormal lipid levels, and, by extension, heart disease risk, the study validates the use of GWAS involving ever larger numbers of people. Previous studies of the genetic factors behind high lipid levels involved 20,000 people, and some had suggested that carrying out larger studies would result in no new variants or variants whose effect is so small as to be of negligible interest from a biological or clinical point of view.
"It is often argued that large-scale meta-analyses with more than 100,000 test subjects have little significance for the biology of complex diseases," said Professor H.-Erich Wichmann of the German Research Center for Environmental Health. "Our study impressively refutes this assertion. On the contrary, some of the newly discovered gene loci have clear biological and clinical relevance."
EU support for the work came from several projects. The ENGAGE (European network for genetic and genomic epidemiology) project is financed through the Health Theme of the Seventh Framework Programme (FP7). INGENIOUS HYPERCARE (Integrated genomics, clinical research and care in hypertension), DIABESITY (Novel molecular drug targets for obesity and type 2 diabetes) and EUROSPAN (European special populations research network: quantifying and harnessing genetic variation for gene discovery) are all funded under the 'Life sciences, genomics and biotechnology for health' Thematic area of the Sixth Framework Programme (FP6). Finally, the GENOMEUTWIN (Genome-wide analyses of European twin and population cohorts to identify genes in common diseases) project was supported under the 'Quality of life and management of the living resources' programme of the EU's Fifth Framework Programme (FP5).
Coronary heart disease is a leading cause of death worldwide. Abnormal levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C, or 'bad' cholesterol), high-density lipoprotein cholesterol (HDL-C) and triglycerides are all known to be major risk factors for heart disease and represent important drug targets.
In their paper, the scientists describe how they carried out a genome-wide association study (GWAS), scanning the genomes of 100,000 people of European descent and looking for changes in the genetic material that are associated with changes in lipid levels.
"Although blood concentrations of cholesterol and triglycerides have long between known as risk factors for cardiovascular disease, the extent to which genetics contributes to those concentrations and just how alterations in the underlying genes leads to the development of disease has been incredibly difficult to piece together," explained Dr Sekar Kathiresan of Massachusetts General Hospital in the US.
The researchers' analyses uncovered 95 genetic variants, 59 of which were previously unknown. According to the team, taken together the 95 variants 'explain 10%-12% of the total variance (representing 25%-30% of the genetic variance'.
Many of the variants are located in genes known to be linked to lipid levels and heart disease. "Closer scrutiny of the gene loci revealed genetic variants which we know offer a molecular target for cholesterol-lowering drugs," commented Professor Thomas Meitinger of the German Research Center for Environmental Health.
The scientists also scanned the genomes of thousands of people of East Asian, south Asian and African American descent. This revealed that the majority of the variants are shared across diverse ethnic groups.
"The new findings point us to specific genetic signposts that allow us to understand more fully why many people from all walks of life have abnormal levels of cholesterol and other blood lipids that lead to heart disease," said Christopher O'Donnell of the National Institutes of Health (NIH) in the US. "What's really exciting about this work is that we are moving from discovery to understanding brand-new information about how genes alter the lipids that contribute to heart disease."
As well as shedding light on the genetic causes of abnormal lipid levels, and, by extension, heart disease risk, the study validates the use of GWAS involving ever larger numbers of people. Previous studies of the genetic factors behind high lipid levels involved 20,000 people, and some had suggested that carrying out larger studies would result in no new variants or variants whose effect is so small as to be of negligible interest from a biological or clinical point of view.
"It is often argued that large-scale meta-analyses with more than 100,000 test subjects have little significance for the biology of complex diseases," said Professor H.-Erich Wichmann of the German Research Center for Environmental Health. "Our study impressively refutes this assertion. On the contrary, some of the newly discovered gene loci have clear biological and clinical relevance."
EU support for the work came from several projects. The ENGAGE (European network for genetic and genomic epidemiology) project is financed through the Health Theme of the Seventh Framework Programme (FP7). INGENIOUS HYPERCARE (Integrated genomics, clinical research and care in hypertension), DIABESITY (Novel molecular drug targets for obesity and type 2 diabetes) and EUROSPAN (European special populations research network: quantifying and harnessing genetic variation for gene discovery) are all funded under the 'Life sciences, genomics and biotechnology for health' Thematic area of the Sixth Framework Programme (FP6). Finally, the GENOMEUTWIN (Genome-wide analyses of European twin and population cohorts to identify genes in common diseases) project was supported under the 'Quality of life and management of the living resources' programme of the EU's Fifth Framework Programme (FP5).
Pharma Marketing 2010 - Frankfurt
30 September 2010, Frankfurt, Germany.
Pharma Marketing 2010 in Frankfurt provides a key platform for Europe's pharmaceutical industry stakeholders, such as yourself, to discover how best to tackle the key challenges of a price-sensitive and increasingly competitive and rapidly changing market.
This event offers the perfect setting for industry peers to present their ideas and successes directly to key decision makers from leading pharmaceutical companies. At this meeting you will meet and interact with senior level marketing executives, through a number of one-on-one meetings and networking activities.
They will discuss the challenges and strategies used to enhance online communication, customer relationship, strengthen brand awareness and improve profitability in marketing. This is your one-stop-shop to the most up to date online marketing strategies, regulatory low down, measuring ROI, analytical tools and more such as:
5 reasons why Pharma should not do E-marketing
The successful commercialisation of a pharma brand start with an effective launch
Forecasting is easy, communication is difficult
Achieving Launch Excellence in a Challenging Pharma Marketplace
The Doctor - Patient - Pharma: a triangle about a patient's health improvement.
Balancing "old" and "new" marketing strategies
Brand Management
Why Online Belongs to the Pharma Marketing Mix
Joins some of the experts like:
IMS heath, Director commercial effectiveness EMEA
UCB Pharma, Head of eStrategies
Novartis Oncology Region Europe, Regional Brand Leader
Eli Lilly, Director Human Resources
Astellas Pharma,Marketing Director
Genzyme, Associate Director Global Commercial Effectiveness and Development
AstraZneca, VP Global Marketing
Allergan, Director Consumer Marketing
Google, Industry Head
And many more ...
Who should attend?
This conference is designed to attract key decision makers from the Pharmaceutical industry: Presidents, Managing Directors, Country Managers, General Managers, Vice Presidents, Regional Directors/ Heads, Directors, Department Heads, Managers.
For further information and registration, please visit:
http://nwbg.eu/all-events/pharma-marketing-2010/
Pharma Marketing 2010 in Frankfurt provides a key platform for Europe's pharmaceutical industry stakeholders, such as yourself, to discover how best to tackle the key challenges of a price-sensitive and increasingly competitive and rapidly changing market.
This event offers the perfect setting for industry peers to present their ideas and successes directly to key decision makers from leading pharmaceutical companies. At this meeting you will meet and interact with senior level marketing executives, through a number of one-on-one meetings and networking activities.
They will discuss the challenges and strategies used to enhance online communication, customer relationship, strengthen brand awareness and improve profitability in marketing. This is your one-stop-shop to the most up to date online marketing strategies, regulatory low down, measuring ROI, analytical tools and more such as:
5 reasons why Pharma should not do E-marketing
The successful commercialisation of a pharma brand start with an effective launch
Forecasting is easy, communication is difficult
Achieving Launch Excellence in a Challenging Pharma Marketplace
The Doctor - Patient - Pharma: a triangle about a patient's health improvement.
Balancing "old" and "new" marketing strategies
Brand Management
Why Online Belongs to the Pharma Marketing Mix
Joins some of the experts like:
IMS heath, Director commercial effectiveness EMEA
UCB Pharma, Head of eStrategies
Novartis Oncology Region Europe, Regional Brand Leader
Eli Lilly, Director Human Resources
Astellas Pharma,Marketing Director
Genzyme, Associate Director Global Commercial Effectiveness and Development
AstraZneca, VP Global Marketing
Allergan, Director Consumer Marketing
Google, Industry Head
And many more ...
Who should attend?
This conference is designed to attract key decision makers from the Pharmaceutical industry: Presidents, Managing Directors, Country Managers, General Managers, Vice Presidents, Regional Directors/ Heads, Directors, Department Heads, Managers.
For further information and registration, please visit:
http://nwbg.eu/all-events/pharma-marketing-2010/
Sunday, August 22, 2010
New Colorectal Cancer Screening Coverage to Drive US Gastrointestinal Endoscopy Device Market to Almost $2.2 Billion by 2014
WALTHAM, Mass.: -- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, new coverage instituted under the Patient Protection and Affordable Care Act of 2010 will remove the financial disincentives associated with colorectal cancer screening for a large segment of the US population. As a result of these changes in reimbursement, a growing number of colorectal cancer screening procedures will be performed through 2014, driving sales of many gastrointestinal endoscopy devices, including videoscopes and biopsy forceps.
Under the health care act, all new health insurance policies must cover preventative exams, including colonoscopies, without charging out-of-pocket fees such as copayments or deductibles. All Medicare patients will therefore have colorectal cancer screening colonoscopies fully covered as of January 1, 2011. This expanded coverage of colorectal cancer screening procedures will increase the number of colonoscopies performed over the next five years. Sales of devices used in the procedures, such as colonoscopes and biopsy forceps, will also rise to meet this growing demand for colorectal cancer screening. Although colonoscopy volumes dipped in 2009 during the recession, they are climbing again and will continue to rise as increased medical insurance coverage encourages more Americans to undergo screening.
"At the height of the economic downturn, many Americans declined to undergo colorectal cancer screening because they lost insurance coverage for it or they felt that paying for a diagnostic procedure when they did not have any symptoms was not a priority for them in economically uncertain times," said Sara Scharf, Ph D, Analyst at MRG. "As this new coverage is put in place,
patients will increasingly get screened for colorectal cancer.
"MRG's new report, US Markets for Gastrointestinal Endoscopy Devices 2010, now includes more segments
competitor coverage, and insights into trends than ever before. The report provides a thorough analysis of procedural trending, emerging markets, competing and complementary procedures, and revenue growth for the major gastrointestinal endoscopy devices in the US, including videoscopes, enteral feeding devices, endoscopic retrograde cholangiopancreatography devices, hemostasis devices, biopsy forceps, stents, virtual colonoscopy systems, esophageal dilation balloons, capsule endoscopes, polypectomy snares, and retrieval devices. For the first time, this report includes market analyses of enteral feeding giving sets, nasogastric tubes, colonic and duodenal stents, and Barrett's esophagus ablation devices.
Under the health care act, all new health insurance policies must cover preventative exams, including colonoscopies, without charging out-of-pocket fees such as copayments or deductibles. All Medicare patients will therefore have colorectal cancer screening colonoscopies fully covered as of January 1, 2011. This expanded coverage of colorectal cancer screening procedures will increase the number of colonoscopies performed over the next five years. Sales of devices used in the procedures, such as colonoscopes and biopsy forceps, will also rise to meet this growing demand for colorectal cancer screening. Although colonoscopy volumes dipped in 2009 during the recession, they are climbing again and will continue to rise as increased medical insurance coverage encourages more Americans to undergo screening.
"At the height of the economic downturn, many Americans declined to undergo colorectal cancer screening because they lost insurance coverage for it or they felt that paying for a diagnostic procedure when they did not have any symptoms was not a priority for them in economically uncertain times," said Sara Scharf, Ph D, Analyst at MRG. "As this new coverage is put in place,
patients will increasingly get screened for colorectal cancer.
"MRG's new report, US Markets for Gastrointestinal Endoscopy Devices 2010, now includes more segments
competitor coverage, and insights into trends than ever before. The report provides a thorough analysis of procedural trending, emerging markets, competing and complementary procedures, and revenue growth for the major gastrointestinal endoscopy devices in the US, including videoscopes, enteral feeding devices, endoscopic retrograde cholangiopancreatography devices, hemostasis devices, biopsy forceps, stents, virtual colonoscopy systems, esophageal dilation balloons, capsule endoscopes, polypectomy snares, and retrieval devices. For the first time, this report includes market analyses of enteral feeding giving sets, nasogastric tubes, colonic and duodenal stents, and Barrett's esophagus ablation devices.
Daily Intake of 'Yakult' Is Efficacious in Reducing Incidence of Acute Diarrhea in Young Children
YAKULT HONSHA CO., LTD. announced on August 20 that its collaborative study on the incidence of acute diarrhea with the National Institute of Cholera and Enteric Diseases in Kolkata, India, showed that daily intake of "Yakult" is efficacious in reducing the incidence of diarrhea in young children.
An unprecedented large-scale study, involving 3,585 children residing in an urban slum community in Kolkata, was conducted. As a result, "Yakult" was shown to be efficacious in reducing the incidence of acute diarrhea in young children and the difference was statistically significant. The demonstration that the continued intake of "Yakult" is effective in improving the gastrointestinal symptoms of the general public strongly corroborates the significance of drinking "Yakult."
These results were published on the "Epidemiology and Infection" website and the ePub is available on PubMed.
YAKULT HONSHA is engaged in research on probiotics, which refer to living microorganisms that confer a benefit on the host (people, etc.) by improving the balance of intestinal flora. A representative probiotic strain is Lactobacillus casei strain Shirota (YIT9029), which, in addition to an intestinal regulation action, has been verified in many published papers to have immunoregulatory actions such as helping to suppress the recurrence of superficial bladder cancer and reduce allergy symptoms. Hereafter, YAKULT HONSHA will continue to actively promote research on utilizing the remarkable power of microorganisms for the benefit of people's health.
The number of children aged 5 years and under that die annually throughout the world is 8.80 million, and the country that has the most deaths is India (approximately 1.83 million children per year). It is reported that diarrhea is the cause in 13% of the deaths in children aged 5 years and under in India (Black RE et al, Lancet. 2010. 375: 1969-1987).
ble-blind randomized controlled field trial involving 3,585 children aged between 1 and 5 years was carried out in Kolkata, India. The participating children were given either "Yakult" or a placebo drink daily for 12 weeks to observe the incidence of acute diarrhea and pathogenic microbes in the stool.
The results showed that the proportion of children suffering from diarrhea was significantly lower in the "Yakult" group (608 out of 1,802) compared to the placebo group (674 out of 1,783). Moreover, the incidence of diarrhea was lower in the "Yakult" group (0.88/child/year) compared to the placebo group (1.029/child/year) and the difference was statistically significant (p less than 0.01). The analysis of pathogenic bacterial, viral and parasitic agents in the children with diarrhea resulted in the lower detection rate of Aeromonas spp and Cryptosporidium spp in the Yakult group compared to the placebo group.
*The placebo drink did not contain Lactobacillus casei strain Shirota. The taste and color of both the placebo drink and "Yakult" were similar. By comparing the effects of intake of each drink, the efficacy of "Yakult" can be scientifically measured.
An unprecedented large-scale study, involving 3,585 children residing in an urban slum community in Kolkata, was conducted. As a result, "Yakult" was shown to be efficacious in reducing the incidence of acute diarrhea in young children and the difference was statistically significant. The demonstration that the continued intake of "Yakult" is effective in improving the gastrointestinal symptoms of the general public strongly corroborates the significance of drinking "Yakult."
These results were published on the "Epidemiology and Infection" website and the ePub is available on PubMed.
YAKULT HONSHA is engaged in research on probiotics, which refer to living microorganisms that confer a benefit on the host (people, etc.) by improving the balance of intestinal flora. A representative probiotic strain is Lactobacillus casei strain Shirota (YIT9029), which, in addition to an intestinal regulation action, has been verified in many published papers to have immunoregulatory actions such as helping to suppress the recurrence of superficial bladder cancer and reduce allergy symptoms. Hereafter, YAKULT HONSHA will continue to actively promote research on utilizing the remarkable power of microorganisms for the benefit of people's health.
The number of children aged 5 years and under that die annually throughout the world is 8.80 million, and the country that has the most deaths is India (approximately 1.83 million children per year). It is reported that diarrhea is the cause in 13% of the deaths in children aged 5 years and under in India (Black RE et al, Lancet. 2010. 375: 1969-1987).
ble-blind randomized controlled field trial involving 3,585 children aged between 1 and 5 years was carried out in Kolkata, India. The participating children were given either "Yakult" or a placebo drink daily for 12 weeks to observe the incidence of acute diarrhea and pathogenic microbes in the stool.
The results showed that the proportion of children suffering from diarrhea was significantly lower in the "Yakult" group (608 out of 1,802) compared to the placebo group (674 out of 1,783). Moreover, the incidence of diarrhea was lower in the "Yakult" group (0.88/child/year) compared to the placebo group (1.029/child/year) and the difference was statistically significant (p less than 0.01). The analysis of pathogenic bacterial, viral and parasitic agents in the children with diarrhea resulted in the lower detection rate of Aeromonas spp and Cryptosporidium spp in the Yakult group compared to the placebo group.
*The placebo drink did not contain Lactobacillus casei strain Shirota. The taste and color of both the placebo drink and "Yakult" were similar. By comparing the effects of intake of each drink, the efficacy of "Yakult" can be scientifically measured.
Saturday, August 21, 2010
Pharmacy's online service helps care homes improve their support for residents
Pharmacy Plus launched its new Online Service, the service which is freely available to all its customers offers a unique online tool that provides care homes with data and analysis relating to individual patients medication history and drug usage, to enable them to offer improved and personalised care to all their residents.
The more homes use the online system the more they are able to reduce patient risks, as the online data provides care staff and GPs working together, with a very powerful tool to monitor and intervene in the treatment of residents. The result is a reduction in the number of patients who have to be admitted as emergency cases to hospital.
Tariq Muhammad, MD of Pharmacy Plus says, "Part of the inspiration for us to further improve our online service was the introduction of the new CQC Outcomes framework which comes into force on 1st October 2010. Pharmacy Plus believes the changes are on the whole positive and will provide a good opportunity for homes to demonstrate the quality of their service delivery to residents. However, we do feel care homes may require support, such as that offered by our Online Service, to ensure the necessary processes are in place so they are able to meet the new CQC outcomes, especially Outcome 9 - Medicines Management."
The current Pharmacy Plus Online Service is already valued and regularly used by most of its care home customers. However recognizing how much more could be delivered via online services, the company has redeveloped the site to incorporate many new features and functions. As well as giving access to prescription information for each resident in the care home, the new online service will provide statistics, resources, reports, audits and many interactive features. For example homes will be able to record patient reviews that have been carried out and record any interventions that have been made, all this is done using a secure connection between the Care Home and Pharmacy Plus.
Tariq Muhammad goes on to say that, "Over the last few months we have carefully considered how we could more effectively support each care home and also specifically help them to achieve their CQC Outcomes. After lengthy deliberation amongst all our pharmacists we have concluded that we could best do this by creating a set of guidelines, (which explain clearly what the care home needs to do) and show homes how they should use Pharmacy Plus online services to help meet them.
No other Pharmacy does or indeed can provide this type of service to their care home customers, one that helps enable their dedicated staff to deliver the best possible service to residents."
The new website will be available for Pharmacy Plus customers on the company website, for further information, visit www.pharmacyplus.co.uk.
The more homes use the online system the more they are able to reduce patient risks, as the online data provides care staff and GPs working together, with a very powerful tool to monitor and intervene in the treatment of residents. The result is a reduction in the number of patients who have to be admitted as emergency cases to hospital.
Tariq Muhammad, MD of Pharmacy Plus says, "Part of the inspiration for us to further improve our online service was the introduction of the new CQC Outcomes framework which comes into force on 1st October 2010. Pharmacy Plus believes the changes are on the whole positive and will provide a good opportunity for homes to demonstrate the quality of their service delivery to residents. However, we do feel care homes may require support, such as that offered by our Online Service, to ensure the necessary processes are in place so they are able to meet the new CQC outcomes, especially Outcome 9 - Medicines Management."
The current Pharmacy Plus Online Service is already valued and regularly used by most of its care home customers. However recognizing how much more could be delivered via online services, the company has redeveloped the site to incorporate many new features and functions. As well as giving access to prescription information for each resident in the care home, the new online service will provide statistics, resources, reports, audits and many interactive features. For example homes will be able to record patient reviews that have been carried out and record any interventions that have been made, all this is done using a secure connection between the Care Home and Pharmacy Plus.
Tariq Muhammad goes on to say that, "Over the last few months we have carefully considered how we could more effectively support each care home and also specifically help them to achieve their CQC Outcomes. After lengthy deliberation amongst all our pharmacists we have concluded that we could best do this by creating a set of guidelines, (which explain clearly what the care home needs to do) and show homes how they should use Pharmacy Plus online services to help meet them.
No other Pharmacy does or indeed can provide this type of service to their care home customers, one that helps enable their dedicated staff to deliver the best possible service to residents."
The new website will be available for Pharmacy Plus customers on the company website, for further information, visit www.pharmacyplus.co.uk.
Teen Bloggers Outraged By America's Obesity Problem
Teenagers are extremely concerned about America's relationship to food. In a national writing contest for high school students hosted by StageofLife.com, a blogging and writing resource for teens, high school students were asked, "Do we have an obligation to take better care of ourselves by making changes in the way we eat and/or buy and consume food?"
Teens from all 50 states visited the writing contest page and scores participated by submitting an essay. As a whole, the teen bloggers passionately spoke out on a variety of ills tied to the 21st century food industry. Topics ranged from customer observations by a student working at a fast food chicken restaurant to insights that lower-income families often don't have the education, incentive or money to eat healthy.
"Lower socioeconomic groups aren't looking to spend a ton of money at Whole Foods when they can easily go to the nearest fast-food restaurant and pick up the same amount for a lot less," wrote one teen blogger.
Could there be some hope?
StageofLife.com's education and curriculum consultant, Rebecca Thiegs, M. Ed., an honors Language Arts teacher at Red Lion Area Senior High School in Red Lion, PA, thinks so,
"Popular TV shows like NBC's 'Biggest Loser' pull in millions of viewers, and books like Michael Pollan's Food Rules fly off the shelves. Even independent film documentaries like 'Food, Inc.' and 'Super Size Me' now push the conversation of America's unhealthy relationship with food into the mainstream consciousness."
Unfortunately, the truth is that obesity in America is nearing an epidemic, and young people are caught in the crossfire. According to the Journal of the American Medical Association, 32% of US children are overweight and the Robert Wood Johnson Foundation states the nation is now in danger of raising the first generation of American children who will live sicker and die younger than their parents' generation.
In an effort to fight these trends, StageofLife.com released new lesson plans on its education resources page for junior high and high school teachers that provide writing prompts encouraging teenagers to think about their relationship to food and the traditions around the family dining room table. Eating habits develop at home and the website wants to start a dialogue between teens and their parents.
But lesson plans for teachers aren't the only tools being used to help spread the word on the problem. High school senior, Audrey Keathley from Milton Academy in New York, NY was the StageofLife.com winner for the food essay blog contest and she felt a personal responsibility to share her viewpoint,
"I entered the writing contest because I had something to say about this topic...I encourage more students to try putting their writing out there, because chances are somebody, somewhere is going to want to hear what you have to say."
That's StageofLife.com's hope. That students will continue to share their voice and weigh in on real topics that concern them, their community and the world at large.
The August 2010 StageofLife.com writing contest for high school students tackles the subject of improving education. The writing prompt asks teens, "What suggestion(s) do you have to make a positive change at your school or with the educational system as a whole?"
It's a big question, but dozens of the blog entries have already begun to appear. Teen writers must submit their essays through the site by August 31. Rules, details and the submission button can be found at StageofLife.com. Winners receive a gift certificate from Shutterfly.com, SWAG from StageofLife.com, and Featured Writer status on the website.
About Stage of Life(TM): StageofLife.com is a free, grassroots project hosting blogs, information and resources for teens, Gen Y, Gen X, and Baby Boomer generations. Its specialized content includes lesson plan ideas for Language Arts teachers, monthly writing contests for high school students and college students as well as baby story writing contests. In its My Life Rewards® program, site visitors have access to a wide collection of direct merchant partnerships, sponsors and coupon offers giving money saving discounts as StageofLife.com helps provide "Rewards for Life's Journey®."
Teens from all 50 states visited the writing contest page and scores participated by submitting an essay. As a whole, the teen bloggers passionately spoke out on a variety of ills tied to the 21st century food industry. Topics ranged from customer observations by a student working at a fast food chicken restaurant to insights that lower-income families often don't have the education, incentive or money to eat healthy.
"Lower socioeconomic groups aren't looking to spend a ton of money at Whole Foods when they can easily go to the nearest fast-food restaurant and pick up the same amount for a lot less," wrote one teen blogger.
Could there be some hope?
StageofLife.com's education and curriculum consultant, Rebecca Thiegs, M. Ed., an honors Language Arts teacher at Red Lion Area Senior High School in Red Lion, PA, thinks so,
"Popular TV shows like NBC's 'Biggest Loser' pull in millions of viewers, and books like Michael Pollan's Food Rules fly off the shelves. Even independent film documentaries like 'Food, Inc.' and 'Super Size Me' now push the conversation of America's unhealthy relationship with food into the mainstream consciousness."
Unfortunately, the truth is that obesity in America is nearing an epidemic, and young people are caught in the crossfire. According to the Journal of the American Medical Association, 32% of US children are overweight and the Robert Wood Johnson Foundation states the nation is now in danger of raising the first generation of American children who will live sicker and die younger than their parents' generation.
In an effort to fight these trends, StageofLife.com released new lesson plans on its education resources page for junior high and high school teachers that provide writing prompts encouraging teenagers to think about their relationship to food and the traditions around the family dining room table. Eating habits develop at home and the website wants to start a dialogue between teens and their parents.
But lesson plans for teachers aren't the only tools being used to help spread the word on the problem. High school senior, Audrey Keathley from Milton Academy in New York, NY was the StageofLife.com winner for the food essay blog contest and she felt a personal responsibility to share her viewpoint,
"I entered the writing contest because I had something to say about this topic...I encourage more students to try putting their writing out there, because chances are somebody, somewhere is going to want to hear what you have to say."
That's StageofLife.com's hope. That students will continue to share their voice and weigh in on real topics that concern them, their community and the world at large.
The August 2010 StageofLife.com writing contest for high school students tackles the subject of improving education. The writing prompt asks teens, "What suggestion(s) do you have to make a positive change at your school or with the educational system as a whole?"
It's a big question, but dozens of the blog entries have already begun to appear. Teen writers must submit their essays through the site by August 31. Rules, details and the submission button can be found at StageofLife.com. Winners receive a gift certificate from Shutterfly.com, SWAG from StageofLife.com, and Featured Writer status on the website.
About Stage of Life(TM): StageofLife.com is a free, grassroots project hosting blogs, information and resources for teens, Gen Y, Gen X, and Baby Boomer generations. Its specialized content includes lesson plan ideas for Language Arts teachers, monthly writing contests for high school students and college students as well as baby story writing contests. In its My Life Rewards® program, site visitors have access to a wide collection of direct merchant partnerships, sponsors and coupon offers giving money saving discounts as StageofLife.com helps provide "Rewards for Life's Journey®."
Friday, August 20, 2010
FDA Proposes Withdrawal of Low Blood Pressure Drug
The U.S. Food and Drug Administration proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities.
Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.
"We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product."
The FDA issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. This is the first time the agency has issued such a notice for a drug approved under the FDA's accelerated approval regulations. Shire, the maker of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.
Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.
Under accelerated approval, a drug company may obtain approval of a drug used to treat a serious or life-threatening disease or condition based upon a surrogate endpoint. A surrogate endpoint is a clinical marker, such as a positive effect on blood pressure, believed to predict actual clinical benefits such as improved survival or decreased severity of the disease.
Drug companies that obtain approval under this program are required to conduct additional clinical trials after approval to confirm the drug's benefit. If those trials fail to confirm clinical benefit to patients, or if the companies do not pursue the required confirmatory trials with due diligence, the FDA can withdraw approval of the drug using expedited procedures.
According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.
The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.
Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities.
Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.
"We've worked continuously with the drug companies to obtain additional data showing the drug's clinical benefits to patients," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research. "Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product."
The FDA issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. This is the first time the agency has issued such a notice for a drug approved under the FDA's accelerated approval regulations. Shire, the maker of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.
Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.
Under accelerated approval, a drug company may obtain approval of a drug used to treat a serious or life-threatening disease or condition based upon a surrogate endpoint. A surrogate endpoint is a clinical marker, such as a positive effect on blood pressure, believed to predict actual clinical benefits such as improved survival or decreased severity of the disease.
Drug companies that obtain approval under this program are required to conduct additional clinical trials after approval to confirm the drug's benefit. If those trials fail to confirm clinical benefit to patients, or if the companies do not pursue the required confirmatory trials with due diligence, the FDA can withdraw approval of the drug using expedited procedures.
According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.
The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.
Bees Warm Up With A Drink, Too
When we venture out on a cool morning, nothing energises our body like a nice warm drink and new research reveals that bees also use the same idea when they're feeling cold.
A study by internationally renowned insect scientists Drs Melanie Norgate and Adrian Dyer shows that bees also like to keep winter at bay with a warm drink.
The Monash University research, published in the prestigious journal PLoS One, has shown that important pollinators of many of our flowers, native Australian stingless bees, warm up their bodies by having a 'hot' drink on a cool day - or a 'cool' drink in warmer weather.
Working with collaborators from Monash University and the CSIRO, the researchers showed that at a range of ambient temperatures (23-30°C) bees displayed a significant preference for feeding from artificial flowers that presented nectar-like solution that was warmer than the ambient temperature.
"The bees perceived warmth as an important reward in addition to the nutritious nectar that they collect from flowers. However, surprisingly for the research team, when the ambient temperature reached 34°C, the bees began preferring a cooler feeder," Dr Dyer said.
"The study showed that just as a person might choose which type of drink to have depending on the weather, the bees also made a decision on their drink, based on what flowers might offer nectar at the ideal temperature for the particular climatic conditions."
The researchers then measured the body temperature of bees after they had ingested warm liquid nectar.
"The bees' preference for warm liquid was then examined by using special infrared cameras that recorded the body temperature of bees whilst resting, flying, or drinking nectar of different temperatures. The thermal images revealed an interesting pattern as the warm nectar helped bees maintain a body temperature (30-34°C) that is likely to be required by insects to maintain active flight," Dr Dyer.
"Choosing nectar of various temperatures appears to be a novel behavioural mechanism bees use to maintain the most suitable body temperature for flight," Dr Norgate said.
Future work will concentrate on understanding what flower features enable plants to modulate the temperature of their flowers to present rewards to pollinating insects, and how this may be important for the distribution of flowers in different regions where climatic conditions like temperature are variable or changing.
A study by internationally renowned insect scientists Drs Melanie Norgate and Adrian Dyer shows that bees also like to keep winter at bay with a warm drink.
The Monash University research, published in the prestigious journal PLoS One, has shown that important pollinators of many of our flowers, native Australian stingless bees, warm up their bodies by having a 'hot' drink on a cool day - or a 'cool' drink in warmer weather.
Working with collaborators from Monash University and the CSIRO, the researchers showed that at a range of ambient temperatures (23-30°C) bees displayed a significant preference for feeding from artificial flowers that presented nectar-like solution that was warmer than the ambient temperature.
"The bees perceived warmth as an important reward in addition to the nutritious nectar that they collect from flowers. However, surprisingly for the research team, when the ambient temperature reached 34°C, the bees began preferring a cooler feeder," Dr Dyer said.
"The study showed that just as a person might choose which type of drink to have depending on the weather, the bees also made a decision on their drink, based on what flowers might offer nectar at the ideal temperature for the particular climatic conditions."
The researchers then measured the body temperature of bees after they had ingested warm liquid nectar.
"The bees' preference for warm liquid was then examined by using special infrared cameras that recorded the body temperature of bees whilst resting, flying, or drinking nectar of different temperatures. The thermal images revealed an interesting pattern as the warm nectar helped bees maintain a body temperature (30-34°C) that is likely to be required by insects to maintain active flight," Dr Dyer.
"Choosing nectar of various temperatures appears to be a novel behavioural mechanism bees use to maintain the most suitable body temperature for flight," Dr Norgate said.
Future work will concentrate on understanding what flower features enable plants to modulate the temperature of their flowers to present rewards to pollinating insects, and how this may be important for the distribution of flowers in different regions where climatic conditions like temperature are variable or changing.
Potential HIV Drug Keeps Virus Out Of Cell.
Following up a pioneering 2007 proof-of-concept study, a University of Utah biochemist and colleagues have developed a promising new anti-HIV drug candidate, PIE12-trimer, that prevents HIV from attacking human cells.
Michael S. Kay, M.D., Ph.D., associate professor of biochemistry in the University of Utah School of Medicine and senior author of the study published Wednesday, Aug. 18, 2010, online by the Journal of Virology, is raising funds to begin animal safety studies, followed by human clinical trials in two to three years. Kay believes PIE12-trimer is ideally suited for use as a vaginal microbicide (topically applied drug) to prevent HIV infection. His research group is particularly focused on preventing the spread of HIV in Africa, which has an estimated two-thirds of the world's 33 million HIV patients according to the World Health Organization.
"We believe that PIE12-trimer could provide a major new weapon in the arsenal against HIV/AIDS. Because of its ability to block the virus from infecting new cells, PIE12-trimer has the potential to work as a microbicide to prevent people from contracting HIV and as a treatment for HIV infected people. HIV can develop resistance rapidly to existing drugs, so there is a constant need to develop new drugs in hopes of staying ahead of the virus." Kay said.
PIE12-trimer was designed with a unique "resistance capacitor" that provides it with a strong defense against the emergence of drug-resistant viruses.
Peptide drugs have great therapeutic potential, but are often hampered by their rapid degradation in the body. D-peptides are mirror-image versions of natural peptides that cannot be broken down, potentially leading to higher potency and longevity in the body. Despite these potential advantages, no D-peptides have yet been developed.
PIE12-trimer consists of three D-peptides (PIE12) linked together that block a "pocket" on the surface of HIV critical for HIV's gaining entry into the cell. "Clinical trials will determine if PIE12-trimer is as effective in humans as it is in the lab," Kay said.
Across the world, HIV occurs in many different strains and has the ability to mutate to resist drugs aimed at stopping it. Due to the high conservation of the pocket region across strains, PIE12-trimer worked against all major HIV strains worldwide, from Southeast Asia and South America to the United States and Africa.
To help advance toward human clinical trials, Kay and co-authors Brett D. Welch, Ph.D., and Debra M. Eckert, Ph.D., research assistant professor of biochemistry, formed a company, Kayak Biosciences, which is owned by the University of Utah Research Foundation. If PIE12-trimer proves to be an effective and safe drug against HIV, the same D-Peptide drug design principles can be applied against other viruses, according to Kay. Approval of the first D-peptide drug would also greatly stimulate development of other D-peptide drugs.
Michael S. Kay, M.D., Ph.D., associate professor of biochemistry in the University of Utah School of Medicine and senior author of the study published Wednesday, Aug. 18, 2010, online by the Journal of Virology, is raising funds to begin animal safety studies, followed by human clinical trials in two to three years. Kay believes PIE12-trimer is ideally suited for use as a vaginal microbicide (topically applied drug) to prevent HIV infection. His research group is particularly focused on preventing the spread of HIV in Africa, which has an estimated two-thirds of the world's 33 million HIV patients according to the World Health Organization.
"We believe that PIE12-trimer could provide a major new weapon in the arsenal against HIV/AIDS. Because of its ability to block the virus from infecting new cells, PIE12-trimer has the potential to work as a microbicide to prevent people from contracting HIV and as a treatment for HIV infected people. HIV can develop resistance rapidly to existing drugs, so there is a constant need to develop new drugs in hopes of staying ahead of the virus." Kay said.
PIE12-trimer was designed with a unique "resistance capacitor" that provides it with a strong defense against the emergence of drug-resistant viruses.
Peptide drugs have great therapeutic potential, but are often hampered by their rapid degradation in the body. D-peptides are mirror-image versions of natural peptides that cannot be broken down, potentially leading to higher potency and longevity in the body. Despite these potential advantages, no D-peptides have yet been developed.
PIE12-trimer consists of three D-peptides (PIE12) linked together that block a "pocket" on the surface of HIV critical for HIV's gaining entry into the cell. "Clinical trials will determine if PIE12-trimer is as effective in humans as it is in the lab," Kay said.
Across the world, HIV occurs in many different strains and has the ability to mutate to resist drugs aimed at stopping it. Due to the high conservation of the pocket region across strains, PIE12-trimer worked against all major HIV strains worldwide, from Southeast Asia and South America to the United States and Africa.
To help advance toward human clinical trials, Kay and co-authors Brett D. Welch, Ph.D., and Debra M. Eckert, Ph.D., research assistant professor of biochemistry, formed a company, Kayak Biosciences, which is owned by the University of Utah Research Foundation. If PIE12-trimer proves to be an effective and safe drug against HIV, the same D-Peptide drug design principles can be applied against other viruses, according to Kay. Approval of the first D-peptide drug would also greatly stimulate development of other D-peptide drugs.
H1N1 in post-pandemic period.Director-General's opening statement at virtual press conference 10 August 2010
he world is no longer in phase 6 of influenza pandemic alert. We are now moving into the post-pandemic period. The new H1N1 virus has largely run its course.
These are the views of members of the Emergency Committee, which was convened earlier today by teleconference.
The Committee based its assessment on the global situation, as well as reports from several countries that are now experiencing influenza. I fully agree with the Committee’s advice.
As we enter the post-pandemic period, this does not mean that the H1N1 virus has gone away. Based on experience with past pandemics, we expect the H1N1 virus to take on the behaviour of a seasonal influenza virus and continue to circulate for some years to come.
In the post-pandemic period, localized outbreaks of different magnitude may show significant levels of H1N1 transmission. This is the situation we are observing right now in New Zealand, and may see elsewhere.
In fact, the actions of health authorities in New Zealand, and also in India, in terms of vigilance, quick detection and treatment, and recommended vaccination, provide a model of how other countries may need to respond in the immediate post-pandemic period.
Globally, the levels and patterns of H1N1 transmission now being seen differ significantly from what was observed during the pandemic. Out-of-season outbreaks are no longer being reported in either the northern or southern hemisphere. Influenza outbreaks, including those primarily caused by the H1N1 virus, show an intensity similar to that seen during seasonal epidemics.
During the pandemic, the H1N1 virus crowded out other influenza viruses to become the dominant virus. This is no longer the case. Many countries are reporting a mix of influenza viruses, again as is typically seen during seasonal epidemics.
Recently published studies indicate that 20–40% of populations in some areas have been infected by the H1N1 virus and thus have some level of protective immunity. Many countries report good vaccination coverage, especially in high-risk groups, and this coverage further increases community-wide immunity.
Pandemics, like the viruses that cause them, are unpredictable. So is the immediate post-pandemic period. There will be many questions, and we will have clear answers for only some. Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period.
Based on available evidence and experience from past pandemics, it is likely that the virus will continue to cause serious disease in younger age groups, at least in the immediate post-pandemic period. Groups identified during the pandemic as at higher risk of severe or fatal illness will probably remain at heightened risk, though hopefully the number of such cases will diminish.
In addition, a small proportion of people infected during the pandemic, including young and healthy people, developed a severe form of primary viral pneumonia that is not typically seen during seasonal epidemics and is especially difficult and demanding to treat. It is not known whether this pattern will change during the post-pandemic period, further emphasizing the need for vigilance.
As I said, pandemics are unpredictable and prone to deliver surprises. No two pandemics are ever alike. This pandemic has turned out to be much more fortunate than what we feared a little over a year ago.
This time around, we have been aided by pure good luck. The virus did not mutate during the pandemic to a more lethal form. Widespread resistance to oseltamivir did not develop. The vaccine proved to be a good match with circulating viruses and showed an excellent safety profile.
Thanks to extensive preparedness and support from the international community, even countries with very weak health systems were able to detect cases and report them promptly.
Had things gone wrong in any of these areas, we would be in a very different situation today.
I will be happy to answer your questions.
These are the views of members of the Emergency Committee, which was convened earlier today by teleconference.
The Committee based its assessment on the global situation, as well as reports from several countries that are now experiencing influenza. I fully agree with the Committee’s advice.
As we enter the post-pandemic period, this does not mean that the H1N1 virus has gone away. Based on experience with past pandemics, we expect the H1N1 virus to take on the behaviour of a seasonal influenza virus and continue to circulate for some years to come.
In the post-pandemic period, localized outbreaks of different magnitude may show significant levels of H1N1 transmission. This is the situation we are observing right now in New Zealand, and may see elsewhere.
In fact, the actions of health authorities in New Zealand, and also in India, in terms of vigilance, quick detection and treatment, and recommended vaccination, provide a model of how other countries may need to respond in the immediate post-pandemic period.
Globally, the levels and patterns of H1N1 transmission now being seen differ significantly from what was observed during the pandemic. Out-of-season outbreaks are no longer being reported in either the northern or southern hemisphere. Influenza outbreaks, including those primarily caused by the H1N1 virus, show an intensity similar to that seen during seasonal epidemics.
During the pandemic, the H1N1 virus crowded out other influenza viruses to become the dominant virus. This is no longer the case. Many countries are reporting a mix of influenza viruses, again as is typically seen during seasonal epidemics.
Recently published studies indicate that 20–40% of populations in some areas have been infected by the H1N1 virus and thus have some level of protective immunity. Many countries report good vaccination coverage, especially in high-risk groups, and this coverage further increases community-wide immunity.
Pandemics, like the viruses that cause them, are unpredictable. So is the immediate post-pandemic period. There will be many questions, and we will have clear answers for only some. Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period.
Based on available evidence and experience from past pandemics, it is likely that the virus will continue to cause serious disease in younger age groups, at least in the immediate post-pandemic period. Groups identified during the pandemic as at higher risk of severe or fatal illness will probably remain at heightened risk, though hopefully the number of such cases will diminish.
In addition, a small proportion of people infected during the pandemic, including young and healthy people, developed a severe form of primary viral pneumonia that is not typically seen during seasonal epidemics and is especially difficult and demanding to treat. It is not known whether this pattern will change during the post-pandemic period, further emphasizing the need for vigilance.
As I said, pandemics are unpredictable and prone to deliver surprises. No two pandemics are ever alike. This pandemic has turned out to be much more fortunate than what we feared a little over a year ago.
This time around, we have been aided by pure good luck. The virus did not mutate during the pandemic to a more lethal form. Widespread resistance to oseltamivir did not develop. The vaccine proved to be a good match with circulating viruses and showed an excellent safety profile.
Thanks to extensive preparedness and support from the international community, even countries with very weak health systems were able to detect cases and report them promptly.
Had things gone wrong in any of these areas, we would be in a very different situation today.
I will be happy to answer your questions.
Wednesday, August 18, 2010
Granules India Posts Revenue of Rs.109.3 Cr. for Q1 FY11 - Revenue of Rs.109.33 Cr. - Net profit of Rs.1.92 Cr. - Standalone turnover at Rs.90.51 Cr.
Granules India Ltd., a vertically integrated formulation manufacturer, announced financial results for its fiscal year 2011, first quarter ended June 30, 2010. On a consolidated basis, Granules posted revenue of Rs.109.33 Cr. and a net profit of Rs.1.92 Cr.
Net Sales: Rs.109.33 Cr, as compared to the same period last year at Rs.105.92 Cr.
Net Profit: Rs.1.92 Cr, as compared to the same period last year at Rs.8.68 Cr.
EPS: Basic EPS was Rs.0.96 as compared to the same period last year at Rs.4.33.
On a standalone basis, the Company achieved sales of Rs.90.51 Cr. and a net profit of Rs.1.90 Cr.
"Granules continues to show resilient growth despite a challenging environment. While we grew revenue, profit after tax was adversely affected due to restatement of foreign currency debt. We had to write off an amount of Rs.1.87 cr. in the current year as compared to a gain of Rs.4.45 cr. in the previous year. The company also incurred a bad debt write-off that reduced profit before taxes by Rs.1.80 Cr. Excluding the one-time write-off and a non-cash foreign exchange charge, our profit before tax margin would have been 6.36% as compared to 5.16% in the previous year. From an operations standpoint, this was an important quarter for the Company because we received U.S. FDA approval for our Metformin abbreviated new drug application (ANDA). This is an important milestone as we continue to strengthen our formulation unit." said C. Krishna Prasad, Managing Director of Granules.
Granules India Ltd. is a vertically integrated formulation manufacturer. The Company is a large-scale manufacturer of Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs), which are distributed in over 50 countries. The Company's operations and logistics expertise along with its scale allow Granules to provide customers high quality products across the pharmaceutical manufacturing value chain at a cost-effective price.
Net Sales: Rs.109.33 Cr, as compared to the same period last year at Rs.105.92 Cr.
Net Profit: Rs.1.92 Cr, as compared to the same period last year at Rs.8.68 Cr.
EPS: Basic EPS was Rs.0.96 as compared to the same period last year at Rs.4.33.
On a standalone basis, the Company achieved sales of Rs.90.51 Cr. and a net profit of Rs.1.90 Cr.
"Granules continues to show resilient growth despite a challenging environment. While we grew revenue, profit after tax was adversely affected due to restatement of foreign currency debt. We had to write off an amount of Rs.1.87 cr. in the current year as compared to a gain of Rs.4.45 cr. in the previous year. The company also incurred a bad debt write-off that reduced profit before taxes by Rs.1.80 Cr. Excluding the one-time write-off and a non-cash foreign exchange charge, our profit before tax margin would have been 6.36% as compared to 5.16% in the previous year. From an operations standpoint, this was an important quarter for the Company because we received U.S. FDA approval for our Metformin abbreviated new drug application (ANDA). This is an important milestone as we continue to strengthen our formulation unit." said C. Krishna Prasad, Managing Director of Granules.
Granules India Ltd. is a vertically integrated formulation manufacturer. The Company is a large-scale manufacturer of Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs), which are distributed in over 50 countries. The Company's operations and logistics expertise along with its scale allow Granules to provide customers high quality products across the pharmaceutical manufacturing value chain at a cost-effective price.
Xenon Pharmaceuticals Initiates a Phase 2 Clinical Trial in Post Herpetic Neuralgia (PHN) for Topical XEN402.
Xenon Pharmaceuticals Inc. announced today that it has initiated a phase 2 clinical trial evaluating its novel topical XEN402 therapy for the treatment of PHN.
XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability phase 1 study in normal human volunteers. The product was well tolerated and achieved good drug concentrations in the skin. Topical XEN402 is being developed by Xenon for painful neuropathic disorders such as PHN and targets the sodium channel sub-type Nav1.7. This target is highly expressed in sensory nerve endings and its expression has been shown to be up-regulated in chronic painful conditions such as PHN.
"This is an important step forward in the development of topical XEN402," said Xenon President & CEO, Dr. Simon Pimstone. "This is a truly unique product built on our genetic studies that showed Nav1.7 deficient humans are completely unable to feel pain. By treating pain locally at its source through Nav1.7 block, topical XEN402 could be a very effective and safe treatment option. Our pre-clinical data show excellent efficacy with topical XEN402 in multiple inflammatory and neuropathic pain models when compared to other topical agents and additive effects to existing oral pain treatments. We are excited by these findings as the product could eventually treat multiple chronic painful conditions. This progress signifies another example of Xenon transitioning its target discovery engine to human proof-of-concept trials."
Xenon's VP, Clinical Development, Dr. Paul Goldberg referred to topical XEN402 as a "potentially transformative therapy as leading agents have significant side effects and often leave many patients still in pain. As such there is a large unmet medical need for a novel analgesic that is both effective and safe. We see topical XEN402 being used both a
s a monotherapy and as an adjuvant agent as well," he added.
Xenon expects to conclude the phase 2 trial in Q1, 2011 with top-line data available in Q2, 2011.
XEN402 has been developed by Xenon as a topical ointment formulation and recently concluded a 21-day cumulative dose safety tolerability phase 1 study in normal human volunteers. The product was well tolerated and achieved good drug concentrations in the skin. Topical XEN402 is being developed by Xenon for painful neuropathic disorders such as PHN and targets the sodium channel sub-type Nav1.7. This target is highly expressed in sensory nerve endings and its expression has been shown to be up-regulated in chronic painful conditions such as PHN.
"This is an important step forward in the development of topical XEN402," said Xenon President & CEO, Dr. Simon Pimstone. "This is a truly unique product built on our genetic studies that showed Nav1.7 deficient humans are completely unable to feel pain. By treating pain locally at its source through Nav1.7 block, topical XEN402 could be a very effective and safe treatment option. Our pre-clinical data show excellent efficacy with topical XEN402 in multiple inflammatory and neuropathic pain models when compared to other topical agents and additive effects to existing oral pain treatments. We are excited by these findings as the product could eventually treat multiple chronic painful conditions. This progress signifies another example of Xenon transitioning its target discovery engine to human proof-of-concept trials."
Xenon's VP, Clinical Development, Dr. Paul Goldberg referred to topical XEN402 as a "potentially transformative therapy as leading agents have significant side effects and often leave many patients still in pain. As such there is a large unmet medical need for a novel analgesic that is both effective and safe. We see topical XEN402 being used both a
s a monotherapy and as an adjuvant agent as well," he added.
Xenon expects to conclude the phase 2 trial in Q1, 2011 with top-line data available in Q2, 2011.
6 Million Children in Desperate Need - Deadly water-borne diseases threaten child survival
UNICEF warned today that serious funding shortfalls are jeopardizing its humanitarian operation in Pakistan. UNICEF is extremely concerned at the lack of funds for its water and sanitation operation, with millions of children at risk from water-borne diseases.
"Providing clean water and adequate sanitation is key to the survival of millions of flood-affected people in Pakistan. In terms of numbers of people needing life-saving assistance, this emergency is bigger than the Tsunami, Haiti, and the last Pakistan earthquake put together," said UNICEF Representative in Pakistan, Martin Mogwanja.
"UNICEF is currently providing enough clean water for 1.3 million people every day, but millions more need the same services. We urgently need to scale up the distribution of water. If we are not able to do so because of lack of funding, water-borne diseases such as cholera, diarrhea and dysentery will spread and begin killing affected populations, especially children, already weak and vulnerable to disease and malnutrition," added Mogwanja.
The Government of Pakistan estimates 20 million people overall have been hit by the flood crises, and according to the United Nations at least 15 million people have been seriously affected, half of whom are children.
"It is unbearable to think that six million kids in immediate danger may not get clean water, nutrition and shelter because of a funding shortage," said President and CEO of the U.S. Fund for UNICEF Caryl Stern. "UNICEF is completely dependent on voluntary donations; if we don't raise funds, we can't respond to this emergency. Please help us get word out, and please donate whatever you can to help us meet the need. Even a dollar will be put to good use and help save lives."
UNICEF is concerned that the floods have hit "the poorest of the poor," those least able to survive the present harsh conditions. The top concerns are water-borne diseases, acute respiratory infections, skin diseases and malnutrition rates, already dangerously high in many flood-affected regions of Pakistan.
Polio is endemic and measles still a threat, says UNICEF, which, together with WHO and Government, is carrying out polio and measles vaccinations at relief centers. UNICEF is also supplying oral rehydration solution, a home based treatment for diarrhea, but notes that this treatment is also in short supply due to funding constraints.
"Providing clean water and adequate sanitation is key to the survival of millions of flood-affected people in Pakistan. In terms of numbers of people needing life-saving assistance, this emergency is bigger than the Tsunami, Haiti, and the last Pakistan earthquake put together," said UNICEF Representative in Pakistan, Martin Mogwanja.
"UNICEF is currently providing enough clean water for 1.3 million people every day, but millions more need the same services. We urgently need to scale up the distribution of water. If we are not able to do so because of lack of funding, water-borne diseases such as cholera, diarrhea and dysentery will spread and begin killing affected populations, especially children, already weak and vulnerable to disease and malnutrition," added Mogwanja.
The Government of Pakistan estimates 20 million people overall have been hit by the flood crises, and according to the United Nations at least 15 million people have been seriously affected, half of whom are children.
"It is unbearable to think that six million kids in immediate danger may not get clean water, nutrition and shelter because of a funding shortage," said President and CEO of the U.S. Fund for UNICEF Caryl Stern. "UNICEF is completely dependent on voluntary donations; if we don't raise funds, we can't respond to this emergency. Please help us get word out, and please donate whatever you can to help us meet the need. Even a dollar will be put to good use and help save lives."
UNICEF is concerned that the floods have hit "the poorest of the poor," those least able to survive the present harsh conditions. The top concerns are water-borne diseases, acute respiratory infections, skin diseases and malnutrition rates, already dangerously high in many flood-affected regions of Pakistan.
Polio is endemic and measles still a threat, says UNICEF, which, together with WHO and Government, is carrying out polio and measles vaccinations at relief centers. UNICEF is also supplying oral rehydration solution, a home based treatment for diarrhea, but notes that this treatment is also in short supply due to funding constraints.
Tuesday, August 17, 2010
EVA BIO TRADE X PVT LTD ANNOUNCES A JV WITH LAMAR NATURAL PRODUCTS PVT LTD (CIPLA)
Eva Bio Trade X Pvt Ltd. is one of the leading pharmaceutical companies and provides high quality, affordable and innovative solutions in medicines and treatment. The company which is an initiative of Prashant Chaudhary and Ajay Kumar Mehra was started a year back.
The duo together has now announced a joint venture with Lamar Natural Products Pvt Ltd (Cipla). The pharmaceutical products are manufactured by Cipla and its allies Lamar in different categories that range from lifestyle, men, women, to child care segments.
Eva Bio Trade X Pvt. Ltd. will be the marketing partner for these products in India. Lamar Natural products Pvt. Ltd. (Cipla) will be taking care of the production while Eva Bio Trade X will explore the marketing possibilities. In addition, Eva Bio Trade X Pvt. Ltd. will establish the network of supply chain management and marketing team across the country. Priority of both the organizations is to create a strong presence in OTC & FMCG segment.
Present at the press conference Shonal Lulla, MD, Lamar Natural Products Pvt. Ltd (Cipla) shared, "All the products are exported to 180 countries and are now being launched in India under the joint venture of "Eva Bio Trade X Pvt Ltd" along with Lamar Natural Products Pvt. Ltd(Cipla) which is a renowned pharmaceuticals corporate".
With a plan to achieve a target of Rs 100 cr in the first year of its operation, Prashant Chaudhary, Director, Eva Bio Trade X said, "Eva Bio Trade X envisions bringing into India some specialized products for the mass. All the products will carry premium benefits at affordable price for the mass. The main objective of the company is to make premium quality products reach to the mass through their professional network of distribution and marketing. The company also foresees to open a gateway to many multinational brands/companies. Eva is also working on some social cause projects and plans to come out with some concrete solution".
Ajay Kumar Mehra, Director, further added, "We at Eva express its sincere thanks to likeminded people joining in this venture. Our Company is very much committed to provide high returns to its distribution team mates specially C&F s from all over the country. And also assures good return of the money to their customers. The main objective will remain to provide true value of money to its customers, distributors and its associated people."
Products by Eva Bio Trade X Pvt Ltd.
Hygiene care products include wet wipes, toilet wipes, and teeth wipes
Pain care products include rapid relief sprays for sprained muscles, medicines for sore throat, and throat inflammation
Nutraceuticals products include medicines that help in strengthening weak bones, anti-diabetic, and anti-ageing medicines
The duo together has now announced a joint venture with Lamar Natural Products Pvt Ltd (Cipla). The pharmaceutical products are manufactured by Cipla and its allies Lamar in different categories that range from lifestyle, men, women, to child care segments.
Eva Bio Trade X Pvt. Ltd. will be the marketing partner for these products in India. Lamar Natural products Pvt. Ltd. (Cipla) will be taking care of the production while Eva Bio Trade X will explore the marketing possibilities. In addition, Eva Bio Trade X Pvt. Ltd. will establish the network of supply chain management and marketing team across the country. Priority of both the organizations is to create a strong presence in OTC & FMCG segment.
Present at the press conference Shonal Lulla, MD, Lamar Natural Products Pvt. Ltd (Cipla) shared, "All the products are exported to 180 countries and are now being launched in India under the joint venture of "Eva Bio Trade X Pvt Ltd" along with Lamar Natural Products Pvt. Ltd(Cipla) which is a renowned pharmaceuticals corporate".
With a plan to achieve a target of Rs 100 cr in the first year of its operation, Prashant Chaudhary, Director, Eva Bio Trade X said, "Eva Bio Trade X envisions bringing into India some specialized products for the mass. All the products will carry premium benefits at affordable price for the mass. The main objective of the company is to make premium quality products reach to the mass through their professional network of distribution and marketing. The company also foresees to open a gateway to many multinational brands/companies. Eva is also working on some social cause projects and plans to come out with some concrete solution".
Ajay Kumar Mehra, Director, further added, "We at Eva express its sincere thanks to likeminded people joining in this venture. Our Company is very much committed to provide high returns to its distribution team mates specially C&F s from all over the country. And also assures good return of the money to their customers. The main objective will remain to provide true value of money to its customers, distributors and its associated people."
Products by Eva Bio Trade X Pvt Ltd.
Hygiene care products include wet wipes, toilet wipes, and teeth wipes
Pain care products include rapid relief sprays for sprained muscles, medicines for sore throat, and throat inflammation
Nutraceuticals products include medicines that help in strengthening weak bones, anti-diabetic, and anti-ageing medicines
Global Health Trax Debuts New Liquid Fiber Dietary Supplements for Improved Digestive Health
Global Health Trax, Inc., a leading nutraceutical manufacturer, has added to its lineup of digestive health products with the debut of Clarifiber™ and Yummy Fiber™ for kids featuring a smooth, clear fiber in a highly absorbable liquid form. The new liquid fiber dietary supplements join the ranks of ThreeLac, the company’s top-selling, original probiotic that, for over a decade, has fostered intestinal health with beneficial microflora.
“I highly recommend the use of a quality fiber product such as Clarifiber when taking probiotics because it assists in the removal of bad bacteria die-off,” said Dr. Gary Shima, MD, of the Health and Wellness Institute in San Marcos, Calif. “Additionally, the proprietary blend in Clarifiber contains ingredients that actually benefit the growth of beneficial bacteria in your colon.”
Clarifiber is a 100% natural proprietary fiber supplement blend developed and manufactured by Global Health Trax. The clear, tasteless, gluten-free product is easy to consume, as it can be combined with any food or liquid. Yummy Fiber is a clear liquid fiber supplement with a mild fruit flavor for kids. A 100% natural fiber source containing seven grams of dietary fiber, the supplement can be taken by itself or mixed in with kids’ favorite foods and drinks, such as juice, yogurt or applesauce. Both Clarifiber and Yummy Fiber are specifically formulated to enhance probiotic regimens, supporting overall digestive and intestinal health maintenance.
For more information and to purchase Global Health Trax’s digestive health products, visit http://www.ghthealth.com. Global Health Trax strongly recommends that consumers consult their healthcare provider to discuss which supplements are best for them.
“I highly recommend the use of a quality fiber product such as Clarifiber when taking probiotics because it assists in the removal of bad bacteria die-off,” said Dr. Gary Shima, MD, of the Health and Wellness Institute in San Marcos, Calif. “Additionally, the proprietary blend in Clarifiber contains ingredients that actually benefit the growth of beneficial bacteria in your colon.”
Clarifiber is a 100% natural proprietary fiber supplement blend developed and manufactured by Global Health Trax. The clear, tasteless, gluten-free product is easy to consume, as it can be combined with any food or liquid. Yummy Fiber is a clear liquid fiber supplement with a mild fruit flavor for kids. A 100% natural fiber source containing seven grams of dietary fiber, the supplement can be taken by itself or mixed in with kids’ favorite foods and drinks, such as juice, yogurt or applesauce. Both Clarifiber and Yummy Fiber are specifically formulated to enhance probiotic regimens, supporting overall digestive and intestinal health maintenance.
For more information and to purchase Global Health Trax’s digestive health products, visit http://www.ghthealth.com. Global Health Trax strongly recommends that consumers consult their healthcare provider to discuss which supplements are best for them.
Lilly Halts Development Of Semagacestat for Alzheimer's Disease.
Eli Lilly and Company will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.
The company's decision does not affect the ongoing clinical trials of solanezumab, Lilly's other compound in Phase III trials as a potential Alzheimer's treatment. While both drugs focus on amyloid-beta proteins, which are believed to play a critical role in Alzheimer's disease, they have different mechanisms of action. Lilly also has two other compounds in earlier stages of clinical development; those studies are not affected by today's announcement.
In two pivotal Phase III trials, semagacestat was compared with placebo in more than 2,600 patients with mild-to-moderate Alzheimer's disease. Lilly has now reviewed data from a pre-planned interim analysis of semagacestat studies. This interim analysis showed that, as expected, cognition and the ability to complete activities of daily living of placebo-treated patients worsened. However, by these same measures, patients treated with semagacestat worsened to a statistically significantly greater degree than those treated with placebo. In addition, data showed semagacestat is associated with an increased risk of skin cancer compared with those who received placebo.
"This is disappointing news for the millions of Alzheimer's patients and their families worldwide who anxiously await a successful treatment for this devastating illness," said Jan M. Lundberg, Ph.D., Executive Vice President, Science and Technology, and President, Lilly Research Laboratories. "This is a setback, but Lilly's commitment to beating Alzheimer's will not waver."
Lilly is instructing clinical trial investigators for all semagacestat studies to contact study participants as soon as possible and tell them to immediately stop taking the study drug they have received. Study participants or caregivers should call their study physician to schedule their next appointment. Lilly has appropriately informed regulatory agencies and is providing instructions to investigators outlining the process for finalizing the studies.
Lilly's clinical team will continue to gather and evaluate data from these studies, and will publish the results for the benefit of future Alzheimer's research. Although dosing with semagacestat is being stopped, Lilly plans to continue collecting safety data, including cognitive scores, for at least six months through regularly scheduled follow-up visits with study physicians and modifications of the existing Phase III protocols. These additional follow-up visits will help to answer a number of important questions, including whether the differences between patients who received semagacestat and those who received placebo will continue after semagacestat has been discontinued. Other smaller short-term studies will be stopped and participants will receive appropriate follow-up.
The decision to halt development of semagacestat is expected to result in a third-quarter charge to earnings of approximately $.03 to $.04 per share. The company confirmed its previous 2010 earnings per share guidance range of $4.44 to $4.59 on a reported basis, or $4.50 to $4.65 on a non-GAAP basis.
"We are clearly disappointed by the results we are announcing today. However, Lilly's innovation strategy, based on advancing a pipeline of nearly 70 molecules currently in clinical development, does not rest on the success or failure of any single compound," said John C. Lechleiter Ph.D., Lilly's chairman and chief executive officer. "Pharmaceutical research always carries risk, as these results show. But it offers as well the potential for tremendous reward for millions of patients who await new medicines. Despite this and other recent setbacks, Eli Lilly and Company remains financially strong and is even more determined to prevail in our quest to provide new treatments for Alzheimer's and other serious diseases."
About Alzheimer's disease
Alzheimer's disease is a fatal form of dementia that causes progressive decline in memory and other aspects of cognition. It occurs when billions of neurons in the brain begin dying prematurely. Researchers don't know exactly what causes it, but the leading hypothesis is that amyloid beta plaques play an important role.
About semagacestat
Semagacestat is an oral agent designed to reduce the body's production of amyloid beta plaques, which scientists believe play an important role in causing Alzheimer's disease. Semagacestat is believed to block the activity of gamma secretase, an enzyme that is essential to the body's production of amyloid beta plaques. The compound's safety and efficacy are being tested in two Phase III clinical trials called IDENTITY and IDENTITY-2.
About the IDENTITY trials
IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) and IDENTITY-2 are Lilly's Phase III placebo-controlled trials studying semagacestat, a gamma-secretase inhibitor being investigated as a potential treatment to slow the progression of mild to moderate Alzheimer's disease. Both Phase III trials are fully enrolled, with more than 2,600 patients from 31 countries, and include a treatment period of approximately 21 months. An open-label extension study (IDENTITY-XT) is available to all participants completing either study.
All study participants had to be at least 55 years old and meet the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, with certain assessment scores indicating mild to moderate Alzheimer's disease. Patients with more advanced Alzheimer's disease were not included in the studies.
Use of approved treatments for Alzheimer's disease (including donepezil (Aricept), rivastigmine (Exelon), galantamine (Razadyne, RazadyneER), tacrine (Cognex) and memantine (Namenda)) is permitted during the study, provided that such medications had been given for at least 4 months and the dose had been unchanged for 2 months before study participants first received their study drug.
The primary objective of both IDENTITY trials was to determine whether semagacestat given orally would slow the decline associated with Alzheimer 's disease as compared with placebo. The study protocol calls for this to be evaluated periodically for 21 months after initiation of treatment for most patients. A participant's cognition and function are assessed using two 2 co-primary endpoints:
the Alzheimer's disease Assessment Scale - Cognitive subscore (referred to as the ADAS-Cog11); and
the Alzheimer's disease Cooperative Study - Activities of Daily Living Inventory (Referred to as the ADCS-ADL).
The company's decision does not affect the ongoing clinical trials of solanezumab, Lilly's other compound in Phase III trials as a potential Alzheimer's treatment. While both drugs focus on amyloid-beta proteins, which are believed to play a critical role in Alzheimer's disease, they have different mechanisms of action. Lilly also has two other compounds in earlier stages of clinical development; those studies are not affected by today's announcement.
In two pivotal Phase III trials, semagacestat was compared with placebo in more than 2,600 patients with mild-to-moderate Alzheimer's disease. Lilly has now reviewed data from a pre-planned interim analysis of semagacestat studies. This interim analysis showed that, as expected, cognition and the ability to complete activities of daily living of placebo-treated patients worsened. However, by these same measures, patients treated with semagacestat worsened to a statistically significantly greater degree than those treated with placebo. In addition, data showed semagacestat is associated with an increased risk of skin cancer compared with those who received placebo.
"This is disappointing news for the millions of Alzheimer's patients and their families worldwide who anxiously await a successful treatment for this devastating illness," said Jan M. Lundberg, Ph.D., Executive Vice President, Science and Technology, and President, Lilly Research Laboratories. "This is a setback, but Lilly's commitment to beating Alzheimer's will not waver."
Lilly is instructing clinical trial investigators for all semagacestat studies to contact study participants as soon as possible and tell them to immediately stop taking the study drug they have received. Study participants or caregivers should call their study physician to schedule their next appointment. Lilly has appropriately informed regulatory agencies and is providing instructions to investigators outlining the process for finalizing the studies.
Lilly's clinical team will continue to gather and evaluate data from these studies, and will publish the results for the benefit of future Alzheimer's research. Although dosing with semagacestat is being stopped, Lilly plans to continue collecting safety data, including cognitive scores, for at least six months through regularly scheduled follow-up visits with study physicians and modifications of the existing Phase III protocols. These additional follow-up visits will help to answer a number of important questions, including whether the differences between patients who received semagacestat and those who received placebo will continue after semagacestat has been discontinued. Other smaller short-term studies will be stopped and participants will receive appropriate follow-up.
The decision to halt development of semagacestat is expected to result in a third-quarter charge to earnings of approximately $.03 to $.04 per share. The company confirmed its previous 2010 earnings per share guidance range of $4.44 to $4.59 on a reported basis, or $4.50 to $4.65 on a non-GAAP basis.
"We are clearly disappointed by the results we are announcing today. However, Lilly's innovation strategy, based on advancing a pipeline of nearly 70 molecules currently in clinical development, does not rest on the success or failure of any single compound," said John C. Lechleiter Ph.D., Lilly's chairman and chief executive officer. "Pharmaceutical research always carries risk, as these results show. But it offers as well the potential for tremendous reward for millions of patients who await new medicines. Despite this and other recent setbacks, Eli Lilly and Company remains financially strong and is even more determined to prevail in our quest to provide new treatments for Alzheimer's and other serious diseases."
About Alzheimer's disease
Alzheimer's disease is a fatal form of dementia that causes progressive decline in memory and other aspects of cognition. It occurs when billions of neurons in the brain begin dying prematurely. Researchers don't know exactly what causes it, but the leading hypothesis is that amyloid beta plaques play an important role.
About semagacestat
Semagacestat is an oral agent designed to reduce the body's production of amyloid beta plaques, which scientists believe play an important role in causing Alzheimer's disease. Semagacestat is believed to block the activity of gamma secretase, an enzyme that is essential to the body's production of amyloid beta plaques. The compound's safety and efficacy are being tested in two Phase III clinical trials called IDENTITY and IDENTITY-2.
About the IDENTITY trials
IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) and IDENTITY-2 are Lilly's Phase III placebo-controlled trials studying semagacestat, a gamma-secretase inhibitor being investigated as a potential treatment to slow the progression of mild to moderate Alzheimer's disease. Both Phase III trials are fully enrolled, with more than 2,600 patients from 31 countries, and include a treatment period of approximately 21 months. An open-label extension study (IDENTITY-XT) is available to all participants completing either study.
All study participants had to be at least 55 years old and meet the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, with certain assessment scores indicating mild to moderate Alzheimer's disease. Patients with more advanced Alzheimer's disease were not included in the studies.
Use of approved treatments for Alzheimer's disease (including donepezil (Aricept), rivastigmine (Exelon), galantamine (Razadyne, RazadyneER), tacrine (Cognex) and memantine (Namenda)) is permitted during the study, provided that such medications had been given for at least 4 months and the dose had been unchanged for 2 months before study participants first received their study drug.
The primary objective of both IDENTITY trials was to determine whether semagacestat given orally would slow the decline associated with Alzheimer 's disease as compared with placebo. The study protocol calls for this to be evaluated periodically for 21 months after initiation of treatment for most patients. A participant's cognition and function are assessed using two 2 co-primary endpoints:
the Alzheimer's disease Assessment Scale - Cognitive subscore (referred to as the ADAS-Cog11); and
the Alzheimer's disease Cooperative Study - Activities of Daily Living Inventory (Referred to as the ADCS-ADL).
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