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Astellas terminating Aveo tivozanib deal

February 15, 2014 1:18 AM UTC

Astellas Pharma Inc. (Tokyo:4503) is terminating a 2011 deal with Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) to co-develop and commercialize Aveo's tivozanib outside of Asia, effective Aug. 11. Astellas said it made the decision for "strategic reasons" based on the clinical status of the three indications for which tivozanib was evaluated. Aveo said it will provide more details on its corporate strategy and next steps for the inhibitor of VEGF receptors 1, 2 and 3 on March 13, when it is slated to report 4Q13 and 2013 financial results.

Aveo and Astellas have experienced a number of setbacks with tivozanib, including a June 2013 complete response letter from FDA for renal cell carcinoma (RCC). Last month, the partners decided to discontinue the Phase II BATON-BC trial evaluating tivozanib for advanced triple-negative breast cancer. On Friday, the partners also said they will discontinue the Phase II BATON-CRC trial evaluating first-line treatment with tivozanib plus chemotherapy vs. Avastin bevacizumab plus chemotherapy to treat metastatic colorectal cancer (mCRC). In December, Aveo said a planned interim analysis of the trial showed tivozanib was unlikely to meet the primary endpoint of improving progression-free survival (PFS) (see BioCentury Extra, Dec. 13, 2013). ...