Tivozanib is designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, for the treatment of a broad range of cancers.
Under the terms of the agreement, AVEO will receive an initial cash payment of $125m, composed of a $75m license fee and $50m in R&D funding.
AVEO is also eligible to receive approximately $1.3bn in potential milestones comprised of $575m in clinical and regulatory milestones, including $90m in connection with the regulatory filings and market approval of tivozanib in RCC, as well as more than $780m in commercial milestones.
Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America and Astellas will lead commercialization of tivozanib in the European Union (EU).
The companies will share equally all North American and EU development and commercialization costs and profits for tivozanib.
Outside of North America and EU, Astellas will be responsible for the development and commercialization costs of tivozanib and will be obligated to pay AVEO a tiered, double-digit royalty on sales in those territories.
Pursuant to the terms of a licensing agreement between Kyowa Hakko Kirin and AVEO, Kyowa Hakko Kirin retains the rights to develop and commercialize tivozanib in Asia.
AVEO will be responsible for the manufacturing of tivozanib.
Tivozanib is currently being investigated in a pivotal, global Phase 3 clinical trial called TIVO-1 comparing the efficacy and safety of tivozanib to sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC), as well as in additional clinical studies in other solid tumor types as a single agent and in combination with other anti-cancer agents.