Aveo: Partner Opted Not to Seek European Union Approval of Kidney Cancer Drug

Aeo Pharmaceuticals of Cambridge, MA, said that its partner Astellas Pharma, whose world headquarters is in Japan, would not seek marketing approval for an experimental kidney cancer drug in Europe, Reuters reported.

This news comes just after a U.S. Food and Drug Administration (FDA) panel decision in early May, with a 13-to-1 vote in favor of not approving the drug immediately and of recommending an additional clinical trial before the drug tivozanib could be approved for renal cell cancer. A final decision will come after July 26.

Staff reviewers for the FDA previously emphasized that kidney cancer patients taking tivozanib did not survive longer than did patients taking Nexavar, a kidney cancer drug produced by Bayer AG and Onyx Pharmaceuticals. Some analysts reported that these results occurred possibly because the Nexavar patients had other treatments later, the Associated Press reported.

Aveo shares had lost about 55 percent of their value between April 30 and June 1, when FDA reviewers raised questions about the drug.

Astellas does not intend to fund any future studies of tivozanib in renal cell cancer, Aveo wrote in a regulatory filing on Thursday, May 30. As a partner, Astellas would have had to bear new clinical trial costs, and opted out.

“I expect (Aveo) shares to be down a little because if Astellas had decided to go ahead and pursue the [renal cell cancer] indication as well, then obviously they would have to bear half the cost of the study,” RBC Capital Markets analyst Adnan Butt said.

Brian Klein, an analyst for Stifel Nicolaus, said he saw major cost cuts ahead for Aveo because of this news, which was filed with the Securities and Exchange Commission.

The regulatory filing did not indicate whether Astellas had opted to discontinue support for two other studies of the drug, for advanced colorectal and breast cancer.

Butt said he expects, on the basis of this filing, that Astellas would not pull out from the metastatic cancer trials, according to the Associated Press.

After the advisory panel vote, Aveo and Astellas had said they would work with the FDA to address the issues raised by the panel. Aveo CEO Tuan Ha-Ngoc said the company was “extremely disappointed” by the negative FDA panel vote and dismayed by the criticisms of the company’s actions leveled by panel members. Given the negative panel vote, Ha-Ngoc said the FDA will “more likely reach an adverse decision on tivozanib.”

July 2013 (Vol. 5, Number 7)