AVEO Oncology has granted EUSA Pharma European rights to tivozanib for advanced renal cell carcinoma (RCC), the companies said today, in a deal that could generate up to $396.5 million-plus for AVEO.

The deal includes additional territories outside Europe and North America—including South America and South Africa—as well as additional potential indications.

EUSA Pharma agreed to submit a Marketing Authorization Application for tivozanib as a first-line treatment for advanced RCC to the European Medicines Agency in the first quarter of 2016. EUSA also agreed to undertake and fund future regulatory and commercial activities to bring tivozanib to market within the agreement’s territories.

In return, EUSA Pharma will pay AVEO an upfront research and development funding payment of $2.5 million, plus up to $394 million in potential payments tied to achieving development, regulatory, and commercialization milestones. EUSA also agreed to pay AVEO a tiered royalty ranging from a low double-digit, up to mid-20% on net sales of tivozanib in the agreement’s territories.

A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.

“Tivozanib is a strong strategic fit with our portfolio of marketed specialty products, as we increase our focus on oncology,” EUSA Pharma CEO Lee Morley said in a statement.

Added Michael Bailey, AVEO’s president and CEO: Between our partnership with EUSA and our previous agreements with Ophthotech and Pharmstandard, we have a solid foundation to potentially generate near-term capital and long-term value for this important asset while retaining commercial rights to tivozanib in oncology in North America.”

In November 2014, AVEO awarded an exclusive license to Ophthotech to investigate tivozanib outside of Asia for nononcologic diseases of the eye. The deal could generate as much as $105.5 million+ for Aveo—and resurrected a compound less than a year after disappointing clinical results caused Astellas Pharma to terminate a collaboration with Aveo.

In August, AVEO additionally licensed tivozanib to Pharmstandard Group in Russia, Ukraine, and the Commonwealth of Independent States (CIS), for all human disease and condition indications except nononcologic ocular conditions. That deal could generate up to $9 million-plus for AVEO Oncology.

Bailey said the tivozanib partnerships could generate more than $35 million over the next 18 months. When combined with potential payments from other licensed pipeline assets, the payments could provide “substantial” additional funding to support EUSA Pharma’s tivozanib development strategy for North America, he added.








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