Astellas to commercialise new kidney cancer drug in Europe

pharmafile | February 21, 2011 | News story | Sales and Marketing Astellas, Aveo Pharmaceuticals, Cancer, Kidney cancer, rcc, renal cell carcinoma, tivozanib 

Astellas and Aveo Pharmaceuticals are to commercialise Aveo’s investigational kidney cancer drug tivozanib in Europe and the US.

Aveo is to receive $125 million up front from Astellas, with another $1.3 billion in potential milestone payments for the deal.

Global profits will be split 50-50 between the two companies, with Aveo leading activity in North America from its Massachusetts HQ, and Tokyo-based Astellas handling the European Union.

Outside of these territories, Astellas will assume full responsibility for all costs for development and commercialisation, and will pay Aveo a tiered, double-digit royalty on those sales.

Around 200,000 people worldwide were estimated to be diagosed with renal cell carcinoma (RCC) last year, with more than half of them likely to die from it.

Tivozanib is designed to block the VEGF pathway by inhibiting all three VEGF receptors, which play an important role in the formation of new blood vessels – critical in cancer cell growth.

TIVO-1, an ongoing phase III trial, is currently comparing tivozanib to Bayer’s Nexavar, a standard treatment for advanced RCC.

The primary endpoint is to compare progression-free survival of patients, with top-line data expected to be revealed in the middle of this year.

“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,” said Aveo president Tuan Ha-Ngoc.

The companies believe their new arrangement will accelerate tivozanib’s development in other cancer indications, where it has so far been assessed in combination with various agents in phase 1b trials for colorectal cancer and metastatic breast cancer.

“We strongly believe tivozanib has significant potential in multiple cancers beyond RCC and we look forward to working together to maximise the market opportunities for tivozanib,” said Masafumi Nogimori, president of Astellas.

Two angiogenesis inhibitors, Pfizer’s dominant Sutent and GlaxoSmithKline’s challenger Votrient, lead activity in the RCC market.

But analysts predict tivozanib – along with Pfizer’s axitinib – could have a major impact in the RCC market: the Pharmacor 2010 report said these two would account for nearly a third of sales in RCC in 2019.

Adam Hill

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