Aveo Oncology announces positive NICE recommendation for FOTIVDA

Aveo Oncology announces positive NICE recommendation for FOTIVDA

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Aveo Oncology announces positive NICE recommendation

AVEO Oncology (AVEO) announced that the United Kingdom’s National Institute for Health and Care Excellence has published a Final Appraisal Determination recommending FOTIVDA for the first line treatment of adult patients with advanced renal cell carcinoma.

In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with aRCC and for adult patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for aRCC.

Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor.

EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia.

The positive recommendation triggers a $2M milestone payment to AVEO from EUSA Pharma.

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $386M in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories.

Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe.

In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

AVEO closed at $3.05.


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