Aveo Pharmaceuticals ($AVEO) has landed a rich, $1.4 billion development and commercialization pact with Astellas for its late-stage VEGF inhibitor tivozanib. Now in a Phase III head-to-head study comparing the drug to Nexavar, Astellas will spearhead the commercialization work for tivozanib in Europe, leaving Aveo in charge in the U.S.
In exchange for the worldwide pact--excluding Asia, where Kyowa Hakko Kirin has already taken the lead--Aveo gets $125 million covering the upfront fee and R&D costs along with the promise for as much as $1.3 billion more in milestones. That includes $575 million in clinical and regulatory milestones and more than $780 million in commercial milestones.
For Aveo, the deal for tivozanib--which targets all three VEGF receptors--marks a major turning point. The pact comes as the developer is ramping up its Cambridge operations. CEO Tuan Ha-Ngoc tells FierceBiotech this morning that the company has just signed off on a lease for a third building neighboring its current headquarters. And Aveo plans to beef up its work force from about 150 now to some 220 at the end of this year. By the end of 2012, he says, the workforce could swell to some 300 staffers as the biotech shifts gears and launches a commercialization program - provided it can win an FDA approval. And Aveo plans to speed up its development work for other tumor types, particularly for breast and colorectal cancer.
"We can really accelerate the development of the drug for other solid tumors," says the CEO, "even without waiting for the results of TIVO-1 in RCC." Topline data from the ongling Phase III is expected in the middle of this year with an NDA slated for the first half of 2012.
There's no guarantee, of course, that tivozanib will win approval. But Astellas was inspired to ink a blockbuster deal based on data suggesting that the therapy has a solid shot at going on to become a frontline cancer therapy. "The Aveo drug appears to be the best of that class," based on data released last year, George Farmer, an analyst with Canaccord Genuity, tells Bloomberg. "Our view is it will probably be competitive with Sutent."
"We share Aveo's vision for oncology drug development and confidence that the TIVO-1 trial is positioned for success," said Masafumi Nogimori, president and chief executive officer of Astellas. "We also strongly believe tivozanib has significant potential in multiple cancers beyond RCC and we look forward to working together to maximize the market opportunities for tivozanib and improving the treatment of cancer patients."
- read the Aveo release
- here's the Bloomberg report