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Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY)
“We are pleased with this positive clinical outcome,” said
“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said
The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. 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.
“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars,
The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.
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 met PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.
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 approval from the
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
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