On November 15, 2018 AVEO Oncology (NASDAQ: AVEO) reported the triggering of a $2 million milestone payment to AVEO from EUSA Pharma (Press release, AVEO, NOV 15, 2018, View Source [SID1234531364]). The milestone payment relates to the commercial launch and reimbursement in Germany of FOTIVDA (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma (RCC). In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with RCC 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 RCC. 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 milestone payment is subject to a 30% sublicense fee due to AVEO’s partner Kyowa Hakko Kirin and is incremental to the previously-disclosed cash, cash equivalents and marketable securities at September 30, 2018, which AVEO reported would fund operations into the second quarter of 2019.
"Germany is among a growing list of countries in the European Union that recognize the benefit of expanding patient access to FOTIVDA," said Michael Bailey, president and chief executive officer. "As our partner EUSA continues to advance FOTIVDA in the approved European commercial market, we continue to work toward retrieving overall survival data not yet collected at the preliminary OS analysis of our pivotal TIVO-3 study, and toward the potential submission of a New Drug Application with the FDA for tivozanib as a treatment for advanced or metastatic RCC, a milestone we expect to reach in the first half of 2019."
Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $384 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.3 Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.