Kyowa Kirin Buys Back Tivozanib Non-Oncology Rights from AVEO Oncology
01 August 2019 - 8:00PM
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
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9.
- Pawlowski N et al. AACR 2013. Poster 3971.
- Barthelemy et al. ESMO 2018. Poster 878P
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190801005415/en/
AVEO: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com Kyowa Kirin: Hiroki Nakamura
+81-3-5205-7205 media@kyowakirin.com
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