Astellas finally bails on Aveo, giving up on the thrice-failed tivozanib

Aveo CEO Tuan Ha-Ngoc

Japan's Astellas Pharma has seen enough of tivozanib, washing its hands of the once-promising cancer drug and putting an end to a three-year collaboration with Aveo Oncology ($AVEO).

Citing "strategic reasons," Astellas is discontinuing the drug's last remaining trial--a Phase II in colorectal cancer--and planning to hand back all rights to Aveo by Aug. 11.

The move comes as little surprise in light of tivozanib's yearlong downward spiral. First, the FDA shot down its hoped-for approval in renal cell carcinoma, calling its pivotal data "uninterpretable" and leading the biotech to lay off more than half of its staff. Then, in December, Astellas and Aveo further dashed hopes for the VEGF blocker by revealing that it was unlikely to meet its primary endpoint in a study on colorectal cancer. Finally, last month, the two shut down a Phase II study on tivozanib in breast cancer when it failed to enroll enough patients, closing the book on the drug's last potential indication.

For Aveo, Astellas' exit likely spells the end of development for tivozanib, and the company's second most advanced asset, the lung cancer treatment ficlatuzumab, hasn't been heard from since missing a key endpoint in a 2012 Phase II trial. The active remnants of the biotech's pipeline are AV-203, a Phase I treatment for various solid tumors, and AV-380, a preclinical asset for cancer-related weight loss.

In its third-quarter earnings release, Aveo said it planned to end 2013 with $115 million in cash, enough to survive through at least the first half of 2015. Just how a partnerless Aveo will proceed remains unclear, however, and CEO Tuan Ha-Ngoc didn't offer any details.

"Given today's announcements, we are re-aligning our resources behind key development opportunities to bring clinically meaningful treatments to patients and create shareholder value," Ha-Ngoc said in a statement. "We look forward to outlining our corporate strategy when we report our fourth quarter and full year 2013 results."

- read the announcement

Special Report: 2012's top 10 late-stage cancer drugs - Tivozanib

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