Navigation Links
Coherus Announces CHS-0214 (Proposed Etanercept Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study
Date:10/28/2013

REDWOOD CITY, Calif., Oct. 28, 2013 /PRNewswire/ -- 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.

Coherus Biosciences Contact
George Montgomery
(650) 649-3530 
gmontgomery@coherus.com



'/>"/>
SOURCE Coherus BioSciences
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Valeant Pharmaceuticals Announces Settlement Agreement With Anacor
2. Regulus Announces Significant Progress in Strategic Alliance with AstraZeneca and Selection of a New Pre-Clinically Validated microRNA Oncology Target
3. The Society of Pharmaceutical and Biotech Trainers Announces John Sjovall as New Board President
4. Volcano Announces Upcoming Data Presentations from Large-Scale Studies on Physiology and Imaging Technologies at TCT 2013
5. Comprehensive Care Corporation Announces Extension of $5 Million Credit Facility
6. VirtualScopics Board of Directors Appoints Eric Converse Interim Chief Executive Officer, Announces Resignation of Jeff Markin
7. MEI Pharma Announces Pricing of Public Offering of Common Stock
8. Sorrento Therapeutics Announces Pricing of Public Offering of 4,150,000 Shares of Common Stock and Listing on NASDAQ
9. Lilly announces Tapiero retiring; Zulueta promoted to senior vice president and president of Emerging Markets
10. Webcast Alert: Heska Announces Third Quarter 2013 Earnings Conference Call Webcast
11. IRIDEX Announces Third Quarter 2013 Conference Call and Release Date
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... WILLIAMSBURG, Va. , Feb. 5, 2016  ivWatch, a ... a Virginia Outstanding STEM Award granted by Governor Terry ... for Science Innovation on February 25th at an event to ... . The STEM award honors professionals and business that ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... Feb. 5, 2016 Aethlon Medical, Inc. (Nasdaq: ... and CEO, will be presenting at Source Capital Group,s 2016 ... NY at 2:15 p.m. ET on Wednesday, February ... Panel discussion taking place at 3:15 p.m. ET. ... one hour after the conclusion of the live event. The ...
(Date:2/5/2016)... India , February 5, 2016 ... a new market research report "Fetal (Labor & Delivery) ... & Antepartum), Warmer, Incubator, Pulse Oximeter, Phototherapy/Jaundice Management Devices, ... published by MarketsandMarkets, This report studies the global market ... market is estimated at USD 6.28 Billion in 2015 ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... The American public tends to feel uncomfortable about ... than regular municipal or well water. The recent experience with lead contaminated water in ... a long way toward increasing public acceptance of recycled waste water as drinking water. ...
(Date:2/5/2016)... ... February 05, 2016 , ... Give To Cure today ... for and donate to Give To Cure’s campaign that is crowdfunding clinical trials to ... make and share payments through a smart device. In 2015 alone, Venmo processed $7.5 ...
(Date:2/5/2016)... ... 05, 2016 , ... Pivot Point Consulting, a leading national ... & Services for HIT Implementation Support & Staffing report with an outstanding score ... by healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Justin Scott and Dr. Lydia ... No Cost Dental Day to individuals in need. The event is scheduled to take ... Cost Dental Day is to provide dental care to community members in need. Each ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Ben Amini, ... it is now welcoming orthodontist, Dr. Amanda Cheng, to the practice. With the ... oral health care, including general dentistry, cosmetic treatments, periodontics, implant dentistry , ...
Breaking Medicine News(10 mins):