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Takeda Announces Completion of the Post-Marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS

-- No overall statistically significant increased risk of bladder cancer in patients ever exposed to pioglitazone in a completed 10-year epidemiological study

OSAKA, Japan, Aug. 29, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour, and Welfare (MHLW) / the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).1,2 This study was a 10-year epidemiology study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), and was designed to investigate whether patients exposed to pioglitazone were at an increased risk of bladder cancer.1 Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.2

The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer.2 Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone.

In the five-year interim analysis published in Diabetes Care, a statistically significant increased risk among patients who used pioglitazone for two or more years was observed.1 However, the 10-year final analysis did not show any statistically significant findings of increased risk of bladder cancer with long term use of pioglitazone.2 The data will be shared with additional regulatory authorities in accordance with local requirements around the world, and final results will be submitted for publication in 2014.   

"The completion of this long-term study is a milestone in the history of pioglitazone," said Tom Harris, head, global regulatory affairs, Takeda. "The results of the study provide reassurance with regard to the use of pioglitazone and the risk of bladder cancer and further support the positive benefit risk profile of the product."

About Pioglitazone

Pioglitazone is approved as an agent to treat patients with Type 2 diabetes mellitus in more than ­­­100 countries world-wide. More than 27,000 subjects have been included in clinical trials, and globally the total patient-years of exposure since first launch (1999) is estimated to be in excess of more than 29 million. Pioglitazone as a treatment of Type 2 diabetes mellitus at the recommended doses provides a valuable treatment option, and has a well established safety profile. The benefits of good glycemic control associated with Type 2 diabetes mellitus outweigh the risks associated with therapy which are appropriately communicated and managed by the current product labelling.

Pioglitazone is a thiazolidinedione for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise.

Unlike many oral antidiabetic drugs, pioglitazone is not an insulin secretagogue. Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism. Therefore, pioglitazone is a medication that depends on the presence of insulin for its mechanism of action, and it decreases insulin resistance in muscle and the liver, resulting in increased insulin-dependent glucose disposal as well as decreased hepatic glucose output.

Clinical studies demonstrate that pioglitazone improves insulin sensitivity in insulin-resistant patients. Pioglitazone enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal and improves hepatic sensitivity to insulin. In patients with Type 2 diabetes, the decreased insulin resistance produced by pioglitazone results in lower plasma glucose concentrations, lower plasma insulin concentrations, and lower HbA1c values. In controlled clinical trials, pioglitazone had an additive effect on glycemic control when used in combination with sulfonylurea, metformin, or insulin.

Important Safety Information

Contraindications

Initiation of ACTOS is contraindicated in patients with NYHA Class III or IV heart failure.

ACTOS is contraindicated in patients with known hypersensitivity to pioglitazone or any of its excipients so as to avoid inducing a potentially serious hypersensitivity reaction.

Warnings and Precautions

Fluid retention and cardiac failure: Thiazolidinediones, including ACTOS, can cause dose-dependent fluid retention, which may exacerbate or precipitate heart failure. After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, discontinuation of ACTOS must be considered. ACTOS should be used with caution in patients with cardiac dysfunction whose physical activity is markedly limited. Combination use with insulin may increase risk.

Hepatic effects: Post-marketing reports of hepatitis and hepatic dysfunction have been received. Very rarely these reports have involved hepatic failure, with and without a fatal outcome, although causality has not been established. Obtain liver tests before starting ACTOS and periodically thereafter. Pioglitazone therapy should not be initiated in patients with increased liver enzyme levels (ALT> 2.5x upper limit of normal) or with any other evidence of liver disease. Existing pioglitazone therapy should be discontinued if ALT levels are persistently higher than 3x the upper limit of normal, and symptoms suggesting hepatic dysfunction should cause the liver enzymes to be checked. Pending the results of laboratory investigations, the decision as to whether pioglitazone therapy should continue must be based on clinical judgment; in the presence of jaundice, drug therapy should be discontinued.

Weight gain: Weight gain was observed in clinical trials and has been seen in post-marketing experience with pioglitazone, so patient weight should be closely monitored.

Fractures: An increased incidence of bone fracture has been noted in female patients.

Bladder cancer: Some data suggest there may be an increased risk of bladder cancer in ACTOS users and also that the risk increases with duration of use. Do not use ACTOS in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria or urinary urgency as these may be due to bladder cancer.

Hypoglycemia: When ACTOS is used with insulin, a sulfonylurea or other oral hypoglycemic agents, hypoglycemia may occur.

Ovulation: Ovulation in premenopausal anovulatory women or women with polycystic ovarian syndrome may occur with ACTOS.

Macular edema: Post-marketing reports of new-onset or worsening diabetic macular edema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone. Physicians should consider the possibility of macular edema if a patient reports decreased visual activity.

Drug interactions: Use of ACTOS with CYP2C8 inducers or strong inhibitors may require dose adjustment.

Please refer to the Summary of Product Characteristics (SmPC) for ACTOS before prescribing.

ACTOS should be used according to the indication, posology and method of administration described in the SmPC.

Please consult with your local regulatory agency for approved labeling in your country.

About Type 2 diabetes

  • In 2013, 382 million people worldwide were living with Type 2 diabetes. By 2035 this number is expected to rise to 592 million.3
  • In 2013, the number of people with diabetes in Europe was estimated to be 56 million.4
  • The number of Type 2 diabetes patients is increasing in every country.3
  • In 2013, one in 10 deaths in adults in Europe was attributed to diabetes, representing over 600,000 people.3
  • Estimates indicate that more than EUR 108 billion* was spent on healthcare due to diabetes in the European region in 2013, accounting for over one-quarter of global healthcare expenditures due to diabetes.3
  • Because of the increasingly complex nature of this disease, all patients require treatment to be individualized to their needs.5 Each patient responds differently to medications, and healthcare providers often must combine multiple treatment options to help patients manage their disease.

*Based on conversion of USD 147 billion,3 where 1 EUR = 1.36035 USD as of 21 July 2014.

About Takeda's Diabetes Business

Takeda's heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, and developments of other fixed-dose combinations. The company's strong, diverse diabetes portfolio and available medications mark important milestones in Takeda's ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:

Elissa J. Johnsen
+1-224-554-3185  
elissa.johnsen@takeda.com

References

[1] Lewis, JD., Ferrara, A., Peng, T., et al. The Risk of Bladder Cancer Among Diabetic Patients Treated with Pioglitazone: Interim Report of a Longitudinal Cohort Study. Diabetes Care 24, April 2011 34:4 923-929.

[2] Takeda Data on File. 2014. 

[3] International Diabetes Federation. IDF Atlas, sixth edition. Last accessed July 10, 2014. Available at: http://www.idf.org/diabetesatlas.

[4] International Diabetes Federation. Diabetes: Facts and figures. Last accessed July 10, 2014. Available at: http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures.

[5] Inzucchi SE, Bergenstal RM et al. Management of Hyperglycaemia in Type 2 Diabetes: A Patient-Centred Approach. Diabetes Care. 2012:35: (6):1364-1379.


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Coherus Announces CHS-1420 (Investigational Adalimumab Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study

-- Company To Pursue Next Stage of Development

REDWOOD CITY, California, Aug. 15, 2014  /PRNewswire/ -- Coherus BioSciences, Inc. ("Coherus") today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects. The parallel-group, single-dose study met the criteria for clinical PK similarity on all three required, prospectively defined, PK endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), with all three geometric mean ratios fully within the 90% confidence interval from 80% to 125%. Both agents were well tolerated and there were no differential safety findings observed between the two agents in this study.

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"An essential global regulatory requirement is the completion of a clinical study directly comparing the originator and our biosimilar candidate establishing PK similarity," said Barbara Finck, M.D., Chief Medical Officer of Coherus. "We are pleased to have achieved robust results which we believe represents a significant reduction in development program risk."

"Adalimumab is a very complex molecule. Achieving this clinical milestone further validates Coherus' development platform and demonstrates our ability to advance biosimilars across our portfolio," said Denny Lanfear, President and Chief Executive Officer of Coherus.

About Coherus BioSciences, Inc.
Coherus is a late-stage clinical biologics platform company focused on the global biosimilar market. Headquartered in the San Francisco Bay Area and composed of a team of industry veterans with decades of experience in pioneering biologics companies, our goal is to become a global leader in the biosimilar market by leveraging our team's collective expertise in key areas such as process science, analytical characterization, protein production and clinical-regulatory development. Coherus' commercialization partnerships include global pharmaceutical companies in Europe, Asia and Latin America.

Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. For additional information, please visit www.coherus.com.

Coherus BioSciences Contact
Beth Jimison
+1-650-649-3526
bjimison@coherus.com

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Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma

DARMSTADT, Germany, July 29, 2014 /PRNewswire/ --

  • First patient begins treatment in an international Phase II study investigating the efficacy and safety of MSB0010718C in patients with metastatic Merkel cell carcinoma (mMCC) 
  • mMCC is a rare and aggressive skin cancer lacking effective treatments  
  • MSB0010718C is also currently being explored in a seven cohort Phase I clinical trial for the treatment of solid tumors that aims to recruit 590 patients 

Merck Serono, the biopharmaceutical division of Merck, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). This multicenter, single-arm, open-label study is being conducted in patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin tumor,[1],[2] who have previously received one line of chemotherapy. It is expected to recruit 84 patients across Asia Pacific, Australia, Europe and North America. The primary endpoint of the study is overall response.

The PD-L1/PD-1 pathway is implicated as a major mechanism by which tumors evade elimination by the immune system.[3] The PD-L1 molecule is expressed in many cancer types, including mMCC.[3],[4] MSB0010718C, which blocks the interaction of PD-L1 with its receptor PD-1, may have the potential to restore effective anti-tumor T-cell responses and thereby to inhibit tumor growth.

Immune mechanisms are implicated in the pathogenesis of MCC, with an increased risk observed in immunosuppressed individuals.[5] MCC also is associated with the presence of the Merkel cell polyomavirus, which may have a role in tumor formation.[6] Globally, the incidence of MCC is increasing, and outcomes for patients with this disease are poor.[1],[2] Therefore, new treatment approaches are required to improve the outcome of patients with this type of cancer.

"We believe that modulating the immune system by targeting PD-L1 represents a promising new approach in the treatment of this aggressive cancer, especially considering that many of the predisposing factors for mMCC seem to be related to functional disruptions of the immune system," said Helen Sabzevari, Senior Vice President of Immuno-Oncology at Merck Serono. "Our anti-PD-L1 compound may present a potential new approach for the treatment of mMCC patients. The initiation of this Phase II study is an important milestone, as we endeavor to help those suffering from mMCC, a devastating disease with significant unmet need."

In addition to this new study in mMCC, MSB0010718C is currently being explored in a Phase I clinical trial for the treatment of solid tumors. The study aims to recruit 590 patients and has enrolled 422 patients to date. On June 1, 2014, Merck Serono presented initial data from this dose escalation study in solid tumors at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago.[7] This study is currently recruiting patients into expansion cohorts in seven cancer types: castrate-resistant prostate cancer, colorectal cancer, gastric/gastroesophageal cancer, melanoma, metastatic breast cancer, non-small cell lung cancer and ovarian cancer.

References 

  1. Hughes MP, et al. Curr Dermatol Rep 2014;3:46-53.
  2. Kaae J, et al. J Natl Cancer Inst 2010;102(11):793-801.
  3. Lipson EJ, et al. Cancer Immunol Res 2013;1(1):54-63.
  4. McDermott DF and Atkins MB. Cancer Med 2013; 2(5):662-73.
  5. Bhatia S, et al. Curr Oncol Rep 2011;13(6):488-97.
  6. Feng H, et al. Science 2008;319(5866):1096-100.
  7. Heery CR, et al. J Clin Oncol 2014;32:5(Suppl.) Abstract No. 3064.

About MSB0010718C 

MSB0010718C is an investigational fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses.

About Merkel cell carcinoma (MCC) 

MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings. MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, arms, legs, and trunk. Risk factors for MCC include sun exposure and having a weak immune system (i.e., solid-organ transplant recipients, people with HIV/AIDS and people with other cancers, such as chronic lymphocytic leukemia, are at higher risk). Caucasian males over age 50 are at increased risk.

MCC tends to metastasize at an early stage, spreading initially to nearby lymph nodes, and then potentially to more distant areas in the body, including other lymph nodes or areas of skin, lungs, brain, bones, or other organs.

Current treatment options for MCC include surgery, radiation and chemotherapy. Treatment for metastatic or Stage IV MCC is generally palliative.

About Merck Serono 

Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.

Merck is the world's oldest pharmaceutical and chemical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day.

Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

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TransCelerate Selects Cognizant to Develop a Clinical Trials Collaboration Platform

TEANECK, N.J., July 24, 2014 /PRNewswire/ -- Cognizant (NASDAQ: CTSH) today announced that it has been selected by TransCelerate BioPharma Inc., a non-profit organization with membership representation from 19 major pharmaceutical companies, to develop a first-of-its-kind, subscription-based platform that will transform the way clinical sites collaborate with pharmaceutical companies on clinical trials. TransCelerate BioPharma Inc. is dedicated to making the research and development process more efficient across the pharmaceutical industry.                         

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The Shared Investigator Platform, which will be built as an 'industry utility', will enable the pharmaceutical industry to bring standardization and consistency to clinical trials. Investigator platforms are often deployed by each pharmaceutical company resulting in clinical sites using multiple environments, introducing complexity and risk. By bringing together clinical sites and sponsors spread across the world on a common platform, pharmaceutical companies can run clinical trials more efficiently and accelerate the development of new medicines.

The new platform will enhance organizational productivity by providing investigators and site staff with a central, single access point to clinical trial information, enhancing accuracy, and reducing study start-up time. It will also help pharmaceutical companies to improve quality, regulatory compliance, process visibility, and capacity, while reducing investigator efforts related to training, document exchange, and support. In the future, the platform may provide regulators with an efficient electronic audit process and better insight into clinical trials.

"This collaboration is an important part of TransCelerate's strategy to improve clinical trial processes in order to bring innovative new medicines to patients faster," said Jackie Kent, Senior Director, Clinical Development Information and Optimization, Eli Lilly & Co., and Shared Investigator Platform Leader, TransCelerate. "The Shared Investigator Platform will benefit sites by simplifying processes, and reducing time and effort spent on standard study activities. TransCelerate conducted a comprehensive selection process for this initiative and Cognizant provided the key attributes required for this unique partnership. We anticipate an overall improvement in the quality of studies and the data generated from the Shared Investigator Platform initiative."

"We are pleased to partner with TransCelerate to build this first-of-a-kind platform, which will help maximize the potential of technology-based collaboration and provide better medicines to patients, greater efficiency to clinical sites, and superior business outcomes to pharmaceutical sponsors," said Bhaskar Sambasivan, Vice President of Cognizant's Life Sciences practice. "Streamlining the clinical trials process will enable TransCelerate's member companies to not only speed up drug development, but also drive innovation in improving patient health. We are making a significant commitment and investment in this strategic relationship, and will leverage our industry expertise and technology capabilities to ensure that the proprietary platform, built as an industry utility, delivers optimal value. We will also seek inputs from end-users to continually enhance the platform."

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International team sheds new light on biology underlying schizophrenia

CAMBRIDGE, Mass., July 22, 2014 /PRNewswire/ -- As part of a multinational, collaborative effort, researchers from the Broad Institute, Massachusetts General Hospital (MGH), and scores of other institutions from all over the world have helped identify over 100 locations in the human genome associated with the risk of developing schizophrenia in what is the largest genomic study published on any psychiatric disorder to date. The findings, which are published online in Nature, point to biological mechanisms and pathways that may underlie schizophrenia, and could lead to new approaches to treating the disorder, which has seen little innovation in drug development in more than 60 years.

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Schizophrenia, a debilitating psychiatric disorder that affects approximately 1 out of every 100 people worldwide, is characterized by hallucinations, paranoia, and a breakdown of thought processes, and often emerges in the teens and early 20s. Its lifetime impact on individuals and society is high, both in terms of years of healthy life lost to disability and in terms of financial cost, with studies estimating the cost of schizophrenia at over $60 billion annually in the U.S. alone.

Despite the pressing need for treatment, medications currently on the market treat only one of the symptoms of the disorder (psychosis), and do not address the debilitating cognitive symptoms of schizophrenia. In part, treatment options are limited because the biological mechanisms underlying schizophrenia have not been understood. The sole drug target for existing treatments was found serendipitously, and no medications with fundamentally new mechanisms of action have been developed since the 1950s.

In the genomics era, research has focused on the genetic underpinnings of schizophrenia because of the disorder's high heritability. Previous studies have revealed the complexity of the disease (with evidence suggesting that it is caused by the combined effects of many genes), and roughly two dozen genomic regions have been found to be associated with the disorder. The new study confirms those earlier findings, and expands our understanding of the genetic basis of schizophrenia and its underlying biology. 

"By studying the genome, we are getting a better handle on the genetic variations that are making people vulnerable to psychiatric disease," said Tom Insel, director of the National Institute of Mental Health, which helped fund the study. "Through the wonders of genomic technology, we are in a period in which, for the first time, we are beginning to understand many of the players at the molecular and cellular level."

In the genome-wide association study (GWAS) published in Nature, the authors looked at over 80,000 genetic samples from schizophrenia patients and healthy volunteers and found 108 specific locations in the human genome associated with risk for schizophrenia.  Eighty-three of those loci had not previously been linked to the disorder.

"In just a few short years, by analyzing tens of thousands of samples, our consortium has moved from identifying only a handful of loci associated with schizophrenia, to finding so many that we can see patterns among them," said first author Stephan Ripke, a scientist at the Broad's Stanley Center for Psychiatric Research and the Analytical and Translational Genetics Unit at MGH. "We can group them into identifiable pathways -- which genes are known to work together to perform specific functions in the brain. This is helping us to understand the biology of schizophrenia."

The study implicates genes expressed in brain tissue, particularly those related to neuronal and synaptic function. These include genes that are active in pathways controlling synaptic plasticity -- a function essential to learning and memory -- and pathways governing postsynaptic activity, such as voltage-gated calcium channels, which are involved in signaling between cells in the brain.

Additionally, the researchers found a smaller number of genes associated with schizophrenia that are active in the immune system, a discovery that offers some support for a previously hypothesized link between schizophrenia and immunological processes. The study also found an association between the disorder and the region of the genome that holds DRD2 -- the gene that produces the dopamine receptor targeted by all approved medications for schizophrenia -- suggesting that other loci uncovered in the study may point to additional therapeutic targets.

"The fact that we were able to detect genetic risk factors on this massive scale shows that schizophrenia can be tackled by the same approaches that have already transformed our understanding of other diseases," said the paper's senior author Michael O'Donovan, deputy director of the MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff University School of Medicine. 'The wealth of new findings have the potential to kick-start the development of new treatments in schizophrenia, a process which has stalled for the last 60 years."

The study is the result of several years of work by the Schizophrenia Working Group of the Psychiatric Genomics Consortium (PGC, http://pgc.unc.edu), an international, multi-institutional collaboration founded in 2007 to conduct broad-scale analyses of genetic data for psychiatric disease. One-third of the samples used in the study were genotyped at the Broad Institute, but a total of 55 datasets from more than 40 different contributors were needed to conduct the analysis.

"This level of cooperation between institutions is absolutely essential," said Steve Hyman, director of the Broad's Stanley Center for Psychiatric Research and Distinguished Service Professor of Stem Cell and Regenerative Biology at Harvard University. "Because of the genetic complexity of schizophrenia and other psychiatric disorders, we need a large sample size to conduct this type of research.  If we are to continue elucidating the biology of psychiatric disease through genomic research, we must continue to work together."

The 80,000 samples used in this study represent all of the genotyped datasets for schizophrenia that the consortium has amassed to date. The PGC is currently genotyping new samples to further study schizophrenia and additional psychiatric diseases, including autism and bipolar disorder.   

Core funding for the Psychiatric Genomics Consortium comes from the U.S. National Institute of Mental Health (NIMH), along with numerous grants from governmental and charitable organizations, as well as philanthropic donations. Work conducted at the Stanley Center for Psychiatric Research was funded by the Stanley Medical Research Institute, Merck Research Laboratories, the Herman Foundation, and philanthropic donations.

Paper cited:

Schizophrenia Working Group of the Psychiatric Genomics Consortium. "Biological insights from 108 schizophrenia-associated genetic loci." Nature. July 22, 2014. DOI: 10.1038/nature13595.

About GWAS
Genome-wide association studies (GWAS) examine the frequency of common variations within the human genome to determine which locations in the genome may be linked to a specific phenotype, or trait (usually, a disease). To study these variations, researchers scan strategically selected sites of the genome that are known to vary considerably across the population, taking note of single nucleotide polymorphisms (SNPs) -- single-letter variations in the genetic code. SNPs found to be significantly more common in people with a trait than in those without are considered to be "associated" with that phenotype. Where the associated SNP resides in the genome can provide valuable clues about the genes and mechanisms that may be contributing to the phenotype being studied.

About the Broad Institute of MIT and Harvard
The Eli and Edythe L. Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods and data openly to the entire scientific community.

Founded by MIT, Harvard and its affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to http://www.broadinstitute.org.


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Coherus Announces Initiation Of Phase 3 Trial Of CHS-0214 (Investigational Etanercept Biosimilar) In Chronic Plaque Psoriasis (RaPsOdy)

REDWOOD CITY, Calif., July 16, 2014 /PRNewswire/ -- Coherus BioSciences, Inc. announced the start of its Phase 3 trial of CHS-0214, a proposed biosimilar of etanercept (Enbrel®), in chronic plaque psoriasis (the RaPsOdy trial). This announcement follows the recent initiation of a Phase 3 trial of CHS-0214 in rheumatoid arthritis. The Phase 3 psoriasis trial is a 48-week, randomized, double-blind, active-control, parallel-group, multicenter, global study in subjects with active, chronic plaque psoriasis who are naïve to systemic biologic therapy. The study will seek to demonstrate biosimilarity between CHS-0214 and Enbrel® in terms of efficacy, safety and immunogenicity. The primary efficacy endpoint is based on percent improvement in the Psoriasis Area and Severity Index (PASI) at 12 weeks.

"The initiation of the Phase 3 RaPsOdy trial is an important step toward our goal of increasing access to biosimilar etanercept for patients worldwide," said Barbara Finck, M.D., Chief Medical Officer of Coherus. "It represents a pivotal study in the global clinical development for CHS-0214 and, if positive, will provide support for our marketing applications in Europe, the United States, and a number of other countries."

"Based on our evaluation of the analytical, nonclinical and clinical pharmacokinetic similarity of this molecule, we believe that this molecule has met our rigorous internal criteria for initiating our second Phase 3 trial in 2014," said Denny Lanfear, Coherus Chief Executive Officer. "In concert with our partner Baxter, we are pleased to advance this product into late-stage development."

"With two late-stage trials now underway in partnership with Coherus, we are advancing our collective goals to develop and deliver high quality biologic alternatives that address patient needs," said Ludwig Hantson, Ph.D., president of Baxter BioScience.

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