AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) lost some steam Monday, after it disclosed that the EUSA Pharma has granted positive NICE recommendation for FOTIVDA.
The company, based out of Cambridge, Massachusetts, announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending FOTIVDA®(tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC).
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 (VEGFR) and mTOR pathway inhibitor-naïve 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 $2-million milestone payment to AVEO from EUSA Pharma.
CEO of AVEO Michael Bailey “The recommendation from NICE marks the first European Union reimbursement approval for FOTIVDA, helping ensure broadening patient access to FOTIVDA in key European markets following its launch in Germany in the fall of 2017.
"This recommendation underscores the strength and commercial-stage value of our partnership with EUSA Pharma, and triggers a $2 million milestone payment to AVEO. We continue to execute on our strategic plans, and we have had a very productive 2018 thus far, with the recent presentation of positive preliminary data from our tivozanib and nivolumab combination TiNivo study in RCC and an investigator sponsored study of tivozanib in liver cancer."
AVEO shares docked seven cents, or 2.5%, to $2.97, in late Monday trading.
