Research & Development
Aveo Oncology to Receive USD 2m Milestone Payment from EUSA Pharma Related To Commercialisation of Fotivda in Spain
25 April 2019 - - A USD 2m milestone payment to US-based Aveo Oncology (NASDAQ: AVEO) from EUSA Pharma has been triggered, Aveo said.

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

Commercial launch in Spain is the third of five EU5 country launches to trigger a USD 2m payment under the terms of Aveo's license agreement with EUSA Pharma.

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.

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

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay Aveo up to USD 382m in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialisation objectives, as well as a tiered royalty ranging from a low double-digit up to mid-20% 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 would range from the low- to mid-teens on net sales upon approval and commercialisation.

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 models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.

Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

Aveo Pharmaceuticals is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. The company is working to develop and commercialize its lead candidate tivozanib in North America as a treatment for RCC.

The company has sublicensed 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 also has clinical collaborations to study tivozanib in combination with immune checkpoint inhibitors in RCC and in hepatocellular carcinoma.

In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

As part of the company's strategy, the company has also entered into partnerships to help fund the development and commercialization of its other product candidates.

Ficlatuzumab, a hepatocyte growth factor inhibitory antibody, is currently being tested in several investigator sponsored studies jointly funded by the company and one of its development partners for the potential treatment of squamous cell carcinoma of the head and neck, AML, and pancreatic cancer.

The company's partner for AV-203, an anti-ErbB3 monoclonal antibody, is planning to initiate clinical studies in China in 2019 in esophageal squamous cell carcinoma and has committed to funding the development of AV-203 through proof-of-concept.

The company has recently regained the rights to AV-380, a humanized IgG1 inhibitory monoclonal antibody targeting growth differentiation factor 15, a divergent member of the TGF-ß family, for the potential treatment of cancer cachexia, and is working to initiate preclinical toxicology studies mid-2019 to support the potential filing of an investigational new drug application with the FDA.

The company is evaluating options for the development of its preclinical AV-353 platform which targets the Notch 3 pathway.
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