AVEO Oncology (NASDAQ:AVEO) today announced the triggering of a
$2 million milestone payment to AVEO from EUSA Pharma. 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
(RCC). Commercial launch in Spain is the third of five EU5 country
launches to trigger a $2 million 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.
“We are pleased to see Spain recognize the benefit of patient
access to FOTIVDA® and continued expansion of the FOTIVDA®
commercial footprint in Europe,” said Michael Bailey, president and
chief executive officer of AVEO. “We continue to work toward
reporting more mature interim overall survival results from our
TIVO-3 study in the fourth quarter of 2019, and remain confident in
the significant commercial potential for a VEGF therapy that has
demonstrated activity and tolerability in all lines of RCC therapy,
including highly refractory patients with prior exposure to PD-1
therapy.”
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 $382 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 would range from
the low- to mid-teens on net sales upon approval and
commercialization.
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
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.
About AVEO
AVEO Pharmaceuticals, Inc. (the “Company” or “AVEO”) 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.
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 potential commercial opportunity for
tivozanib; AVEO’s plans to complete an interim OS analysis for the
TIVO-3 trial in August 2019 and to report the results of this
analysis in the fourth quarter; AVEO’s expectation that the OS
outcome will be more mature by August 2019; the potential efficacy,
safety, and tolerability of tivozanib, as a single agent and in
combination with other therapies in several indications, such as
RCC and hepatocellular carcinoma; plans and strategies for
commercialization of tivozanib in the United States and Europe;
AVEO’s plans regarding AV-380 and AVEO’s other strategy, prospects,
plans and objectives for its product candidates and for the Company
generally. 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, and
the ability of its licensees, to demonstrate to the satisfaction of
applicable regulatory agencies such as the FDA and European
regulators the safety, efficacy and clinically meaningful benefit
of AVEO’s product candidates, including, in particular, tivozanib;
AVEO’s ability to successfully file an NDA and obtain FDA approval
for tivozanib in the United States; and AVEO’s ability to enter
into and maintain its third party collaboration and license
agreements, and its ability, and the ability of its strategic
partners, including, in particular, EUSA Pharma, to achieve
development and commercialization objectives under these
arrangements. AVEO faces other risks relating to its business as
well, including risks relating to the timing and costs of seeking
and obtaining regulatory approval; AVEO’s and its collaborators’
ability to successfully enroll and complete clinical trials; AVEO’s
ability to maintain compliance with 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; 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 sections titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s quarterly and annual reports on file
with the Securities and Exchange Commission (SEC) and in other
filings that AVEO makes with the SEC. The forward-looking
statements in this press release represent AVEO’s views as of the
date of this press release, and 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. Any reference to AVEO’s website address in this
press release is intended to be an inactive textual reference only
and not an active hyperlink.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190423005929/en/
David Pitts, Argot Partners(212)
600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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