AVEO Announces EUSA Pharma Granted Positive NICE Recommendation for FOTIVDA® (tivozanib) as First Line Treatment for Advance...
February 12 2018 - 7:02AM
Business Wire
Recommendation Triggers $2M Milestone Payment
from EUSA to AVEO
AVEO Oncology (NASDAQ:AVEO) today announced that the United
Kingdom’s National Institute for Health and Care Excellence (NICE)
has published a Final Appraisal Determination (FAD) recommending
FOTIVDA® (tivozanib) for the first line treatment of adult patients
with advanced renal cell carcinoma (aRCC). In the European Union,
Norway and Iceland, tivozanib is indicated for the first line
treatment of adult patients with aRCC 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 aRCC.1 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 positive
recommendation triggers a $2M milestone payment to AVEO from EUSA
Pharma.
“The recommendation from NICE marks the first European Union
reimbursement approval for FOTIVDA, helping ensure broadening
patient access to FOTIVDA in key European markets following its
launch in Germany in the fall of 2017,” said Michael Bailey,
president and chief executive officer of AVEO. “This recommendation
underscores the strength and commercial-stage value of our
partnership with EUSA Pharma, and triggers a $2 million milestone
payment to AVEO. We continue to execute on our strategic plans, and
we have had a very productive 2018 thus far, with the recent
presentation of positive preliminary data from our tivozanib and
nivolumab combination TiNivo study in RCC and an investigator
sponsored study of tivozanib in liver cancer. We look forward to
several potential additional key milestones in 2018, including
further EU reimbursement decisions as well as topline data in the
second quarter from our Phase 3 TIVO-3 study.”
Under the terms of their December 2015 agreement, EUSA Pharma
has agreed to pay AVEO up to $386 million 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 (KHK) 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.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko 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 models, enabling
potentially enhanced activity when used in combination with immune
modulating therapy. As part of a North American registration plan,
tivozanib is currently being studied in the Phase 3 TIVO-3 trial, a
randomized, controlled, multi-center, open-label study to compare
tivozanib to sorafenib in subjects with refractory advanced RCC.
Tivozanib has been investigated in several tumors types, including
renal cell, hepatocellular, colorectal and breast cancers.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North America as
a treatment for renal cell carcinoma and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in oncology indications outside of North
America, and at progressing its pipeline of novel therapeutic
candidates in cancer and cachexia (wasting syndrome). Tivozanib
(FOTIVDA®) is approved by the European Commission for the treatment
of adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. For more information,
please visit the company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO
that involve substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press
release are forward-looking statements. The words “anticipate,”
“believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,”
“should,” “would,” “seek,” “look forward,” “advance,” “goal,”
“strategy,” or the negative of these terms or other similar
expressions, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about: the expected timeline for further EU
reimbursement decisions as well as reporting data from TIVO-3 ;
potential payments under AVEO’s license agreement with EUSA; and
AVEO’s strategy, prospects, plans and objectives, including as they
pertain specifically to tivozanib. AVEO has based its expectations
and estimates on assumptions that may prove to be incorrect. As a
result, readers are cautioned not to place undue reliance on these
expectations and estimates. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that AVEO makes due to a number of
important factors, including risks relating to AVEO’s ability to
enter into and maintain its third party collaboration and license
agreements, and its ability, and the ability of its collaborators,
licensees and other strategic partners, to achieve development and
commercialization objectives under these arrangements; AVEO’s
ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies the safety, efficacy
and clinically meaningful benefit of AVEO’s product candidates,
including tivozanib. AVEO faces other risks relating to its
business as well, including risks relating to its ability to
successfully enroll and complete clinical trials, including the
TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain
compliance with all regulatory requirements applicable to its
product candidates; AVEO’s ability to obtain and maintain adequate
protection for intellectual property rights relating to its product
candidates and technologies; developments, expenses and outcomes
related to AVEO’s ongoing shareholder litigation; AVEO’s ability to
successfully implement its strategic plans; AVEO’s ability to raise
the substantial additional funds required to achieve its goals,
including those goals pertaining to the development and
commercialization of tivozanib; unplanned capital requirements;
adverse general economic and industry conditions; competitive
factors; and those risks discussed in the section titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
and in other filings that AVEO may make with the SEC in the future.
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 20172. Motzer RJ, Nosov D,
Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
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version on businesswire.com: http://www.businesswire.com/news/home/20180212005638/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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