About 60% of Aveo’s $1.4 billion milestone fees are tied to commercial success.

Astellas Pharma signed an agreement with Aveo Pharmaceuticals covering development and commercialization of the latter’s lead product, an anticancer agent, outside of Asia. Aveo will receive $125 million cash up front and could receive about $1.3 billion tied to achieving clinical, regulatory, and commercial milestones.

The deal is centered around tivozanib, reportedly designed to treat a broad range of cancers by inhibiting all three VEGF receptors. Tivozanib is the subject of a global Phase III program, called TIVO-1, comparing it to Nexavar (Bayer HealthCare and Onyx Pharmaceuticals) in patients with advanced renal cell carcinoma (RCC).

Aveo completed patient enrollment last year. The company expects to announce top-line data from TIVO-1 in mid-2011. In conjunction with this trial and other combination studies, Aveo and Astellas will jointly conduct and fund the expansion of tivozanib clinical development into additional solid tumor types.

Under the agreement Aveo’s initial cash payment of $125 million consists of a $75 million license fee and $50 million in R&D funding. Aveo’s approximately $1.3 billion in milestone payments comprises $575 million in clinical and regulatory milestones—including $90 million in connection with the regulatory filings and market approval of tivozanib in RCC—as well as more than $780 million in commercial milestones.

Subject to regulatory approvals, Aveo will lead commercialization of tivozanib in North America and Astellas, in the 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 pay Aveo a tiered, double-digit royalty on sales in those territories.

“The agreement enables us to build out our North American commercial infrastructure to not only launch tivozanib but also to support future products emerging from our growing oncology pipeline,” states Tuan Ha-Ngoc, president and CEO of Aveo.

Aveo is responsible for all manufacturing of tivozanib. In Asia, Kyowa Hakko Kirin retains the rights to develop and commercialize tivozanib. Aveo acquired the ex-Asia license under a December 2006 agreement obligating the company to make milestone, royalty, and sublicensing revenue payments to Kyowa predecessor Kirin Brewery.

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