Kyowa Kirin Buys Back Tivozanib Non-Oncology Rights from AVEO Oncology

TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) and AVEO Oncology (NASDAQ: AVEO) announce that they have amended their license agreement to allow Kyowa Kirin to buy back the non-oncology rights of tivozanib in AVEO territories, which includes the U.S. and EU. The agreement is an amendment to the terms of the 2006 tivozanib license agreement between Kyowa Kirin and AVEO which granted AVEO exclusive rights of tivozanib in all indications.

Under the terms of the amended license agreement, Kyowa Kirin will reobtain the non-oncology rights of tivozanib in AVEO territories excluding the rights which are currently sublicensed to EUSA Pharma. Kyowa Kirin will be obligated to a $25 million upfront payment to AVEO, waive AVEO’s obligation to make an $18 million milestone payment upon AVEO gaining U.S. marketing approval, and up to $391 million in potential milestone payments upon the successful achievement of certain development and commercial objectives in non-oncology indications of tivozanib. Kyowa Kirin will also be obligated to make tiered royalty payments on the net sales of these indications, which range from a high single-digit to low double-digit percent.

“This is a strategically important agreement for us to maximize the value of tivozanib by keeping it in oncology development by AVEO and having it back to our pipeline in non-oncology areas,” said Takeyoshi Yamashita, Ph.D., Executive Officer, Director of Corporate Strategy & Planning Department of Kyowa Kirin. “This amended agreement on tivozanib is consistent with our portfolio strategy and we’ll keep working to prove its possibility.”

“This agreement marks another chapter in our successful partnership with Kyowa Kirin, and is consistent with our mission to develop and commercialize our oncology-focused pipeline while retaining meaningful economic interest and advancing our non-oncology pipeline through partnerships,” said Michael Bailey, president and chief executive officer of AVEO. “It also provides AVEO with $25 million in non-dilutive capital upfront and an $18 million reduction of potential future payment obligations, which strengthens our balance sheet as we pursue U.S. approval of tivozanib in renal cell carcinoma (RCC) and advance our pipeline programs, including tivozanib-immunotherapy combinations, ficlatuzumab in head and neck squamous cell carcinoma, acute myeloid leukemia, and pancreatic cancer and AV-380 for cachexia. We look forward to realizing the value of Kyowa Kirin’s development initiatives with tivozanib in non-oncology indications.”

About Tivozanib (FOTIVDA®)

Tivozanib (FOTIVDA®) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) 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.1,2 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 RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian, and breast cancers.

About Kyowa Kirin

Kyowa Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world. You can learn more about the business at: www.kyowakirin.com.

About AVEO

AVEO Pharmaceuticals is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. The Company’s lead candidate is tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, which AVEO is working to develop and commercialize in North America as a treatment for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced RCC in the European Union plus Norway and Iceland. AVEO is leveraging or seeks to leverage partnerships to develop and commercialize its pipeline of products and product candidates, including tivozanib in oncology in various geographies, and ficlatuzumab (HGF MAb) in head and neck squamous cell carcinoma, pancreatic cancer and acute myeloid leukemia. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) for various oncology indications.

For more information, please visit the Company’s website at www.aveooncology.com. This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Actual results or events could differ materially due to a number of important factors, including risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

References

1. Fotivda (Tivozanib) SmPC August 2017
2. Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
3. Pawlowski N et al. AACR 2013. Poster 3971.
4. Barthelemy et al. ESMO 2018. Poster 878P

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