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The results are in
REDWOOD CITY, Calif., & BANNOCKBURN, Ill.—Coherus BioSciences, Inc. and Baxalta Incorporated today announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone. The study continues as planned until Week 52.
In other news concerning Baxalta, the Wall Street Journal and others reported that after a tumultuous courtship, Bannockburn, Ill.-based Baxalta has finally said yes to Dublin-based Shire's $32 billion merger proposal.
In July 2015, Shire approached Baxalta about an acquisition. Baxalta had just spun-off from Baxter International on July 1, 2015. Baxalta declined the offer. In early August, Shire publicly revealed the offer in hopes of pressuring the Baxalta board and shareholders into considering the deal. Finally, it appears, Baxalta has said yes.
As if to underscore its desirability as a biosimilar-focused takeover prospect, in the Baxalta-Coherus Phase 3 study results just reported, the primary efficacy endpoint was the proportion of subjects achieving ACR20 (20 percent improvement according to the American College of Rheumatology criteria) at Week 24. The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products.
“Rheumatoid arthritis that remains active despite methotrexate treatment has a significant impact on a patient’s health and quality of life,” said Barbara Finck, M.D., chief medical officer of Coherus. “If approved, CHS-0214 has the potential to expand access and treatment options for patients with moderate-to-severe rheumatoid arthritis and other inflammatory diseases for which etanercept is indicated.”
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 November 2015 and showed that this first study also met its primary endpoints.
“We are pleased that this second pivotal clinical study comparing CHS-0214 to Enbrel has met its primary endpoint,” said Denny Lanfear, president and CEO of Coherus. “We look forward to advancing this product to registration in various territories in 2016.”
“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 Baxalta. “This important clinical milestone, adding to previously-announced positive data in patients with chronic plaque psoriasis, brings us one step closer to expanding treatment options for patients.”
CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic /bioequivalence (PK/BE) studies in healthy volunteers. In bot 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 percent 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.
Coherus is a leading 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.