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Regulatory struggles force Aveo to cut 140 jobs

Expects FDA rejection for tivozanib in kidney cancer

Aveo Oncology logo

Aveo Oncology has announced it will cut 140 jobs based on expectations the US FDA will turn down its lead drug candidate tivozanib in renal cell carcinoma (RCC).

Earlier this year an advisory panel to the FDA voted 13 to 1 that the benefit-to-risk profile of the drug in this kidney cancer indication was not favourable – a result that US-based biotech Aveo said it expects to be replicated in the FDA's final decision.

Furthermore, Aveo said its development partner outside the US Astellas has decided not to file the drug for approval in Europe or support any further trials involving the drug in RCC, bringing to a halt Aveo's plans for the drug in the condition.

“We deeply regret the impact that this decision may have on the RCC community and wish to express our sincere gratitude to the patients and their families, investigators and nurses who have participated in our trials and supported the development of tivozanib in RCC,” said Dr William Slichenmyer, Aveo's chief medical officer.

These regulatory failings have prompted “strategic restructuring” at Aveo, including the employee cull, which accounts for 62 per cent of Aveo's entire workforce.

The company's CEO Tuan Ha-Ngoc said the restructuring was “designed to preserve financial resources in order to support the development of AVEO's products and pipeline”, with AVEO intending to focus on the development of tivozanib in colorectal and breast cancer.

“These were very difficult decisions that were undertaken only after careful consideration,” he said.

Further details of when the job cuts would begin or what departments they would affect were not announced, although Aveo did announce one high profile casualty – executive VP and chief operating officer Elan Ezickson.

According to a company statement, Ezickson will resign on July 31, 2013, to pursue new opportunities, with his responsibilities to be taken over by current chief commercial officer Michael Bailey who will assume the new role of chief business officer once Ezickson departs.

Regarding the future of tivozanib, Aveo said it will continue to work with Astellas on the BATON phase II clinical trials of the drug in the treatment of breast and colorectal cancer.

Results from the colorectal cancer study are expected in 2014 and breast cancer data is expected to follow in late 2014 or 2015.

Other drugs in Aveo's pipeline include the antibody AV-203, which is in phase I development, and hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, which Aveo is looking to develop through external collaborations.

5th June 2013

From: Research



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