Company To Pursue Next Stage of Development as Part of Collaboration with Daiichi Sankyo and Baxter
REDWOOD CITY, CA, USA I October 28, 2013 I Coherus Biosciences, Inc. today announced that its proposed etanercept biosimilar molecule, CHS-0214, an investigational drug, met the primary endpoint of clinical pharmacokinetic (PK) similarity to Enbrel® in a confirmatory clinical study in healthy subjects meeting US, EU, and Japanese regulatory requirements for clinical PK similarity.
Coherus recently announced an agreement with Baxter International, Inc. to develop and commercialize a biosimilar of the etanercept molecule for Europe, Canada, Brazil, and other markets. The company has an existing development collaboration with Daiichi Sankyo in Japan.
The two-period, cross-over study met the study acceptance criteria for clinical PK similarity on all three required 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 to infinity (AUC0-inf). The geometric mean ratios were 98% of CHS-0214 to Enbrel® and were fully within the pre-specified regulatory bounds for the 90% confidence interval for Cmax, AUC0-t,and AUC0-inf.
“This confirmatory clinical PK study is one of two clinical studies required for filing a biosimilar marketing application across most regulatory jurisdictions. We are pleased to have had such robust results, and in the very near future, we plan to start the second required pivotal study to demonstrate similar safety and efficacy to support eventual regulatory approval and licensure,” said Barbara Finck, MD, Chief Medical Officer of Coherus.
“Etanercept is a very complex and challenging molecule. Achieving this milestone demonstrates that Coherus’ scientific and development capabilities enable us to compete successfully in the global biosimilars market across our portfolio,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
About Coherus Biosciences
Coherus Biosciences is a clinical stage, biosimilar biologics company headquartered in the San Francisco Bay Area. The Company was founded by a group of biotech pioneers brought together by the shared vision of using their expertise and knowledge to increase global patient access to high quality, life changing biologic medications. From conceptualization to commercialization, Coherus’ unique business model leverages a strategic consortium of key service providers aligned through ownership and shared incentives. Coherus’ global partnerships include top tier biopharma companies in Europe, Asia, and Latin America who are pursuing the integrated development and commercialization of products representing over $35 billion in current global sales. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, and they have the potential to reduce costs and expand patient access. For additional information, please visit www.coherus.com.
About Baxter International, Inc.
Baxter International, Inc., through its subsidiaries, develops, manufactures, and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals, and biotechnology to create products that advance patient care worldwide.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a “Hybrid Business Model,” which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit www.daiichisankyo.com.
SOURCE: Coherus Biosciences
Post Views: 113
Company To Pursue Next Stage of Development as Part of Collaboration with Daiichi Sankyo and Baxter
REDWOOD CITY, CA, USA I October 28, 2013 I Coherus Biosciences, Inc. today announced that its proposed etanercept biosimilar molecule, CHS-0214, an investigational drug, met the primary endpoint of clinical pharmacokinetic (PK) similarity to Enbrel® in a confirmatory clinical study in healthy subjects meeting US, EU, and Japanese regulatory requirements for clinical PK similarity.
Coherus recently announced an agreement with Baxter International, Inc. to develop and commercialize a biosimilar of the etanercept molecule for Europe, Canada, Brazil, and other markets. The company has an existing development collaboration with Daiichi Sankyo in Japan.
The two-period, cross-over study met the study acceptance criteria for clinical PK similarity on all three required 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 to infinity (AUC0-inf). The geometric mean ratios were 98% of CHS-0214 to Enbrel® and were fully within the pre-specified regulatory bounds for the 90% confidence interval for Cmax, AUC0-t,and AUC0-inf.
“This confirmatory clinical PK study is one of two clinical studies required for filing a biosimilar marketing application across most regulatory jurisdictions. We are pleased to have had such robust results, and in the very near future, we plan to start the second required pivotal study to demonstrate similar safety and efficacy to support eventual regulatory approval and licensure,” said Barbara Finck, MD, Chief Medical Officer of Coherus.
“Etanercept is a very complex and challenging molecule. Achieving this milestone demonstrates that Coherus’ scientific and development capabilities enable us to compete successfully in the global biosimilars market across our portfolio,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
About Coherus Biosciences
Coherus Biosciences is a clinical stage, biosimilar biologics company headquartered in the San Francisco Bay Area. The Company was founded by a group of biotech pioneers brought together by the shared vision of using their expertise and knowledge to increase global patient access to high quality, life changing biologic medications. From conceptualization to commercialization, Coherus’ unique business model leverages a strategic consortium of key service providers aligned through ownership and shared incentives. Coherus’ global partnerships include top tier biopharma companies in Europe, Asia, and Latin America who are pursuing the integrated development and commercialization of products representing over $35 billion in current global sales. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, and they have the potential to reduce costs and expand patient access. For additional information, please visit www.coherus.com.
About Baxter International, Inc.
Baxter International, Inc., through its subsidiaries, develops, manufactures, and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals, and biotechnology to create products that advance patient care worldwide.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a “Hybrid Business Model,” which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit www.daiichisankyo.com.
SOURCE: Coherus Biosciences
Post Views: 113
