Astellas to close down OSI Pharmaceuticals, Perseid Therapeutics

TOKYO—Astellas Pharma Inc. has announced that it will beshutting down two of its research and development offshoot organizations: OSIPharmaceuticals, LLC and Perseid Therapeutics. The closings are part ofAstellas' newly released plan to "reshape its research framework."

OSI Pharmaceuticals is a member of the Astellas UScompanies, and was acquired by Astellas in 2010. The company is "an oncologydrug discovery and translational research organization primarily focused on thediscovery of molecular targeted therapies," Astellas notes on its website.Perseid Therapeutics aims to "discover and develop protein drugs that improvehuman health," with a focus on disorders that can be treated via immunesuppressive therapy. The closing of the two sites will result in thetermination of roughly 200 positions.

In addition, the Astellas Research Institute of America LLCwill also be scaled back, and Astellas also plans to close its Kashima facilityin Osaka, a move that is currently scheduled for fiscal year 2015. The currentfunctions of the facility will be transferred to "appropriate sites, includingthe Tsukuba Research Center."

These initiatives, Astellas noted in a press release, "willbe carried out to reallocate resources and realize operational excellence."Astellas added that the reshaping program will allow thecompany to "enhance its ability to generate innovative drugs by deployingcutting-edge science, accessing to distinguished internal and external talentsand utilizing the optimal research environment."

The announcement is one of several for the company thisweek, comprising a mixed bag of news. Astellas, along with AVEO Oncology, announcedon May 2 that the U.S. Food and Drug Administration's (FDA) Oncologic DrugsAdvisory Committee (ODAC) had voted that the application for tivozanib, aninvestigational vascular endothelial growth factor tyrosine kinase inhibitor,did not demonstrate a favorable benefit-to-risk evaluation for the treatment ofpatients with advanced renal cell carcinoma. The two companies began anagreement in February 2011 for the development and commercialization oftivozanib outside of Asia for a variety of cancers. Though Tuan Ha-Ngoc,president and CEO of AVEO, said in a press release that they are "disappointed withthe outcome of the ODAC vote," they "will work closely with the FDA to addressthe issues discussed by the panel today as the agency continues its ongoingreview of the New Drug Application for tivozanib." The review of the NDA isexpected to be complete by July 28.

The negative vote was offset, however, by the company's May14 announcement with Genentech that the FDA has approved Tarceva tablets as afirst-line treatment of patients with metastatic non-small cell lung cancerwhose tumors present with specific epidermal growth factor receptor activatingmutations detected by an FDA-approved test. Tarceva is already approved in theUnited States for patients with advanced-stage non-small cell lung cancer"whose cancer has not spread or grown after initial treatment with certaintypes of chemotherapy" and for patients with advanced-stage non-small cell lungcancer whose cancer has spread or grown after undergoing at least onechemotherapy regimen.