AVEO Oncology and partner EUSA Pharma on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Fotivda (tivozanib) for treating patients with advanced renal cell carcinoma (RCC). The EMA noted that if approved, the drug will be indicated for the first-line treatment of adults with advanced RCC, as well as for adults who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. Shares in AVEO surged as much as 58 percent on the news.
EUSA explained that the submission was supported by data from the TIVO-1 study involving more than 500 patients with advanced RCC. Results from the trial, which were unveiled in 2012, showed that Fotivda prolonged progression-free survival versus Bayer and Amgen's Nexavar (sorafenib).
AVEO CEO Michael Bailey indicated that a marketing approval for tivozanib by the European Commission would trigger a "$4 million research and development reimbursement payment from EUSA", with AVEO also eligible for up to $12 million in additional milestones from EUSA based on member state reimbursement and regulatory approvals, Bailey added that "these payments would add significant resources to our balance sheet as we work toward the anticipated readout of our US pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018."
Under the terms of a 2015 agreement, AVEO has agreed to pay EUSA as much as $394 million in future R&D funding and milestone payments, in addition to tiered royalties up to the mid-twenty percent range on net (AVEO) sales of Fotivda in the covered regions. AVEO also noted that it has a separate licencing agreement with Kyowa Hakko Kirin (KHK), where 30 percent of milestone and royalty payments received, excluding research and development funding, are due to KHK as a sublicensing fee in Europe, while in the US, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.
In March last year, AVEO reached an agreement to pay $4 million to the US Securities and Exchange Commission to resolve allegations that it misled investors concerning regulatory issues over Fotivda. In 2014, Astellas exercised an option to terminate its agreement to jointly develop Fotivda due to "strategic reasons." The decision was made after the FDA declined to approve the vascular endothelial growth factor tyrosine kinase inhibitor for the treatment of patients with advanced RCC.
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