AVEO Oncology reports positive CHMP opinion for tivozanib as RCC treatment
AVEO Oncology (AVEO) announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has recommended #FOTIVDA for approval as a treatment for patients with advanced renal cell carcinoma.
The #CHMP’s recommendation is now referred to the European Commission.
The EC, which typically adheres to the recommendation of the CHMP, but is not obligated to do so, is expected to make its final decision in about 67 days.
If approved by the EC, marketing authorization for tivozanib will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib.
Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $394M 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 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 says, “If the European Commission grants marketing approval for #tivozanib, it would trigger a $4 million research and development reimbursement payment from EUSA, and AVEO will also be eligible for up to $12M in additional milestones from EUSA based on member state reimbursement and regulatory approvals.
These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018.”
AVEO closed at $0.72. Shares are up 50% in pre-market trading.
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