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Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoint in Phase 3 Rheumatoid Arthritis Clinical Study (RaPsODY)
The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the
“Rheumatoid arthritis that remains active despite methotrexate treatment has a significant impact on a patient’s health and quality of life,” said
This rheumatoid arthritis study is the second of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the first Phase 3 study in patients with chronic plaque psoriasis were released in
“We are pleased that this second pivotal clinical study comparing CHS-0214 to Enbrel has met its primary endpoint,” said
“Etanercept transformed the treatment for many with moderate-to-severe rheumatoid arthritis and other inflammatory conditions, significantly improving patients’ quality of life,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars of
About CHS-0214, a proposed biosimilar of Enbrel® (etanercept)
CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic / bioequivalence (PK / BE) studies in healthy volunteers. In both trials, CHS-0214 demonstrated PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.
CHS-0214 was also evaluated in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. There were no clinically meaningful differences in the safety profiles of the products.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. 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. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products. For additional information, please visit www.coherus.com.
Forward Looking Statement For Coherus
To the extent that statements contained in this press release are not descriptions of historical facts regarding Coherus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the ability of Coherus to obtain regulatory approvals on its desired timelines and the potential benefits of CHS-0214. Such forward-looking statements involve substantial risks and uncertainties that relate to future events and the actual results could differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the biosimilar development process, including the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality or supply for CHS-0214 and Enbrel®, patient safety and patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the company's current and future reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2015.
About Baxalta Incorporated
Forward Looking Statement For Baxalta
This release includes forward-looking statements concerning Baxalta’s collaboration with Coherus on CHS-0214, including expectations with regard to future regulatory actions and potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond
Enbrel® is a registered trademark of Amgen, Inc.
COHERUS INVESTOR AND MEDIA CONTACT:
Keith Vendola, M.D. firstname.lastname@example.org +1 (650) 437-6239 BAXALTA INVESTOR CONTACT: Mary Kay Ladonemary.email@example.com +1 (224) 948-3371 Lorna Williamslorna.firstname.lastname@example.org +1 (224) 948-3511 BAXALTA MEDIA CONTACT: Albert Liaomedia@baxalta.com +1 (617) 834-9285