AVEO Pharmaceuticals, Inc. (AVEO) and partner Astellas Pharma, Inc. (ALPMY) announced their decision to terminate their agreement for the development and commercialization of oncology candidate, tivozanib. The worldwide collaboration and license agreement, which dates back to 2011, will come to an end on Aug 11, 2014, with full rights to tivozanib going back to AVEO.
Meanwhile, the companies have also decided to end a phase II study – BATON (Biomarker Assessment of Tivozanib in ONcology) CRC (colorectal cancer) – evaluating tivozanib. The decision to discontinue the trial did not come as a surprise as AVEO and Astellas had announced in Dec 2013 that data from a planned interim analysis of the phase II BATON– CRC study on tivozanib revealed that it was unlikely to meet the primary endpoint.
This is the latest in tivozanib-related setbacks for AVEO. Last month, the companies decided to end the phase II BATON breast cancer (BC) study due to insufficient enrollment.
Prior to that, in June last year, the companies had received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for tivozanib for advanced renal cell carcinoma (RCC). The FDA informed AVEO that the new drug application (NDA) was not approvable in its present form. Following the CRL, AVEO decided to discontinue tivozanib development for the advanced RCC indication.
Our Take
AVEO’s shares have plunged more than 70% over the last one year. Given the disappointing news related to tivozanib, we expect the shares to continue to fall further. We expect the company to increase its focus on other pipeline candidates including AV-203 (phase I – solid tumor). In the near term, we believe that investor focus will remain on the release of fourth quarter and full year 2013 results (Mar 13, 2014). At that time, AVEO’s plans regarding the future development of tivozanib should be clear.
AVEO carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Emergent BioSolutions, Inc. (EBS) carrying a Zacks Rank #1 (Strong Buy).
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