CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 23, 2019--
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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190423005929/en/
Source: AVEO Oncology, Inc.
David Pitts, Argot Partners
(212) 600-1902
aveo@argotpartners.com