Aveo to cut workforce after FDA knock-back
pharmafile | June 6, 2013 | News story | Research and Development, Sales and Marketing | Aveo, FDA, cuts, tivozanib
Aveo will make major jobs cuts this year after news that a kidney cancer licence for its oncology drug tivozanib will most likely not be granted FDA approval.
The US, Massachusetts-based biotech firm said it would be cutting around 140 jobs – or 64% of its total workforce.
This comes after an advisory panel to the to the FDA said in May that an additional clinical trial would be needed before tivozanib could be approved for treating renal cell carcinoma (RCC), a type of kidney cancer.
The company admitted that is does not expect US regulatory approval for tivozanib to treat RCC.
“As a result of the recent [FDA] meeting, we believe it is likely that tivozanib will not receive FDA approval for renal cell carcinoma,” said William Slichenmyer, chief medical officer of Aveo.
The company says it will now focus on clinical trials for the drug in colon and breast cancers, but would need to shrink its workforce in order to make up for a loss of future earnings expected from the kidney cancer licence.
Cutting staff costs will also help Aveo with other products in its portfolio, which includes the Phase I trial of AV-203 for a number of solid tumours, and ficlatuzumab for certain types of lung cancer, which is being developed with Boehringer.
A recent Phase III trial of the tivozanib showed that it failed to increase survival against its main rival treatment Nexavar, made by Bayer and Onyx Pharmaceuticals. Given these data, analysts had expected the firm to make this decision.
The company said that tivozanib will also not be introduced in Europe for kidney cancer, after Aveo’s marketing partner Astellas late last month said it would not be filing the drug with the EMA.
The firm has not said whether it will seek approval of the drug in treat breast and colon cancer in Europe, but will continue Phase II trials for these licences with Astellas. Data from these trials are expected by early 2015.
Aveo also said in a separate statement that its chief operating officer, Elan Ezickson, had resigned from his post and would leave at the end of next month.
His responsibilities will be handled by chief commercial officer Michael Bailey, who is also tipped to take up a new role as chief business officer after Ezickson’s departure.
Ben Adams
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