On February 12, 2018 AVEO Oncology (NASDAQ:AVEO) reported 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) (Press release, AVEO, FEB 12, 2018, View Source;p=RssLanding&cat=news&id=2331779 [SID1234523907]). 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.1 Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).
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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.
"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," said Michael Bailey, president and chief executive officer of AVEO. "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. We look forward to several potential additional key milestones in 2018, including further EU reimbursement decisions as well as topline data in the second quarter from our Phase 3 TIVO-3 study."
Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $386 million 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.
About Tivozanib (FOTIVDA)
Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy. As part of a North American registration plan, tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.