Daiichi Sankyo said today it was ending its co-development in Japan with Coherus BioSciences of a biosimilar to Amgen’s marketed drug Enbrel® (etanercept) for rheumatoid arthritis, ending a five-year-old partnership by the companies.

The decision came three weeks after the FDA rejected Coherus’ Biologics License Application for a copycat biologic to Amgen’s Neulasta® (pegfilgrastim) in the U.S., leading to Coherus laying off 30% of its workforce.

The Enbrel biosimilar CHS-0214 met its primary endpoint of equivalence with Enbrel in rheumatoid arthritis as well as in psoriasis, following Phase III trials in November 2015 and January 2016, respectively, Coherus disclosed in its Form 10-K annual report for 2016, filed March 14.

Today in a terse statement, the Japanese pharma said the partnership was ending “due to the fact that a commercial manufacturing process to enable the feasible supply of CHS-0214 in Japan cannot be established at this time.”

Outside Japan, Coherus holds rights to CHS-0214. Coherus is still developing CHS-0214 for Europe, with a filing targeted for the second half of this year, according to its website. However, Coherus acknowledged that it does not expect to commercialize the Enbrel biosimilar in the U.S. until patents for the originator drug expire in 2028 and 2029, “assuming these patents are valid and enforceable.”

Enbrel was one of two drugs for which Coherus and Daiich Sankyo agreed in 2012 to create biosimilars in Japan and other Asian countries; the other was Rituxan® (rituximab), which in the U.S. is co-marketed by Biogen and Genentech, a member of the Roche Group. Separately, Daiichi Sankyo last year agreed to partner with Amgen in commercializing for Japan nine biosimilars—including three near-copies of non-Amgen drugs.

Daiichi Sankyo’s halt to its Enbrel biosimilar partnership was Coherus’ second setback in biosimilar development within the past month. On June 12, the FDA responded to Coherus’ BLA for CHS-1701, a biosimilar to Amgen’s marketed drug Neulasta® (pegfilgrastim), with a Complete Response Letter (CRL).

The letter “primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay and requests for certain additional manufacturing related process information,” Coherus acknowledged in a June 12 press release.

“The FDA did not request a clinical study to be performed in oncology patients,” Coherus added. “Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.”

Nine days later on June 21, Coherus eliminated 51 positions through a restructuring that it said would entail aggregate restructuring charges to be recorded in the second quarter. According to a June 27 regulatory filing, those charges include approximately $3.7 million related to one-time termination severance payments and other employee-related costs, including approximately $1.6 million of stock-based compensation expense related to the acceleration of stock options and the extension of post-termination stock option exercise periods.

The majority of the cash payments related to the personnel-related restructuring charges will be paid during the third quarter, with the rest to be paid during the fourth quarter, Coherus said.

Last year, Shire ended a biosimilar Enbrel collaboration with Coherus, enabling Coherus to regain rights to CHS-0214 in territories that include Europe, Canada, Brazil, and the Middle East. That was announced a few weeks after Shire completed its $32 billion acquisition of Baxalta, which originally partnered with Shire to develop the near copy.








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