Policy & Regulation
Aveo Oncology Due USD 2m Milestone Payment from EUSA Pharma Related to German Commercialisation of Fotivda
19 November 2018 - - A USD 2m milestone payment has been triggered, payable to US-based Aveo Oncology (NASDAQ: AVEO) from EUSA Pharma, Aveo said.

The milestone payment relates to the commercial launch and reimbursement in Germany of Fotivda (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma.

In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC.

Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia.

The milestone payment is subject to a 30% sublicense fee due to Aveo's partner Kyowa Hakko Kirin and is incremental to the previously-disclosed cash, cash equivalents and marketable securities at September 30, 2018, which Aveo reported would fund operations into the second quarter of 2019.

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay Aveo up to USD 384m in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement's territories.

Thirty percent of milestone and royalty payments received by Aveo, excluding research and development funding, are due to Kyowa Hakko Kirin as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

Tivozanib (Fotivda) is an oral, once-daily, vascular endothelial growth factor tyrosine kinase inhibitor discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.

Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy.

Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Aveo Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need.

The company's strategy is to retain North American rights to its oncology portfolio while securing partners in development and commercialisation outside of North America.

The company is seeking to develop and commercialise its lead candidate tivozanib in North America as a treatment for advanced or metastatic renal cell carcinoma.

The company has outlicensed tivozanib (FOTIVDA) for oncological indications in Europe and other territories outside of North America.

Tivozanib is approved in the European Union, as well as Norway and Iceland, for the first-line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC.

The company has entered into partnerships for the development and commercialization of AV-203 (CAN017) and ficlatuzumab, both clinical stage assets in oncology.

The company is currently seeking a partner to develop the AV-353 platform, a preclinical asset, worldwide for the potential treatment of pulmonary arterial hypertension and oncology. In addition, a new formulation of tivozanib is being explored in ocular conditions.

The company has recently regained the rights to its AV-380 program for the potential treatment of cachexia and is considering a range of options to advance the program's development.
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