Astellas Tells Aveo to Go It Alone in Kidney Cancer

Xconomy Boston — 

If Aveo Oncology has any plans to sell tivozanib as a kidney cancer drug, it’s going to have to do it without Astellas Pharma.

The fallout from the disastrous May 2 FDA advisory panel continues as Cambridge, MA-based Aveo (NASDAQ: AVEO) revealed in a short filing with the Securities and Exchange Commission that Astellas has no plans to fund any future clinical trials for tivozanib in renal cell carcinoma, also known as kidney cancer. Astellas also won’t file for approval of the drug in Europe. Aveo revealed the news late Thursday, but was actually told of the Astellas decision a week ago, on May 17, according to the filing.

Aveo said little else, only adding that it was “evaluating the effect of Astellas’ decision on the clinical and regulatory path forward” for tivozanib in kidney cancer.

Aveo’s shares, which have lost more than 66 percent of their value this year, were down another 16 percent, to $2.27 apiece, in pre-market trading Friday. The stock was worth more than $8 per share before the advisory panel.

The company received $125 million upfront from Astellas as part of their 2011 agreement to co-develop tivozanib, and it got another $15 million in December from the Japanese drugmaker when the FDA accepted the filing of its new drug application. Astellas also promised Aveo another $1.3 billion in potential cash on the back end of the deal, tied to regulatory and sales milestones.

Despite the news, Aveo and Astellas don’t appear to have severed ties completely. The agreement also included plans to co-develop tivozanib for breast and colorectal cancer.

An FDA advisory panel on May 2 voted 13 to 1 that Aveo should have to run another late-stage clinical trial for tivozanib before winning approval from regulators. Though tivozanib met the main goal of Aveo’s late-stage clinical trial by keeping tumors from spreading longer than Onyx (NASDAQ: ONXX) and Bayer’s approved drug, sorafenib (Nexavar), the panel was highly critical of Aveo’s trial design and the fact that patients that took sorafenib lived longer than those taking tivozanib.

The FDA weighs the input of its advisory committees when it decides whether to approve a drug. The agency’s deadline for reviewing tivozanib is July 28.