AVEO Oncology (NASDAQ:AVEO) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific
committee of the European Medicines Agency (EMA), has recommended
FOTIVDA™ (tivozanib) for approval as a treatment for patients with
advanced renal cell carcinoma (RCC). The CHMP's recommendation is
now referred to the European Commission (EC). The EC, which
typically adheres to the recommendation of the CHMP, but is not
obligated to do so, is expected to make its final decision in about
67 days. If approved by the EC, marketing authorization for
tivozanib will be granted in all 28 countries of the European
Union, Norway, Iceland and Liechtenstein. EUSA
Pharma, a specialty pharmaceutical company with a focus on oncology
and oncology supportive care, is the European licensee for
tivozanib.
“A positive opinion from the CHMP is a critical step in our goal
of obtaining regulatory approval of tivozanib as a treatment for
RCC,” said Michael Bailey, president and chief executive officer of
AVEO. “Tivozanib’s unique tolerability profile together with the
longest progression free survival reported in a Phase 3 first line
RCC study, have the potential to fill an unmet patient need for
better tolerated treatment in this disease. Further, we believe
this tolerability profile could enable immune-oncology combinations
such as those in the Phase 1/2 TiNivo study, which combines the
PD-1 inhibitor Opdivo® (nivolumab) with tivozanib and recently
advanced to Phase 2.”
Mr. Bailey concluded: “If the European Commission grants
marketing approval for tivozanib, it would trigger a $4 million
research and development reimbursement payment from EUSA, and AVEO
will also be eligible for up to $12 million in additional
milestones from EUSA based on member state reimbursement and
regulatory approvals. These payments would add significant
resources to our balance sheet as we work toward the anticipated
readout of our U.S. pivotal trial in third-line RCC, the TIVO-3
trial, in the first quarter of 2018.”
Under the terms of their December 2015 agreement, EUSA Pharma
has agreed to pay AVEO up to $394 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.
RCC is the most common form of kidney cancer,i which accounts
for an estimated 49,000 deaths in Europe each year.ii It is
expected to be one of the fastest increasing cancers over the next
ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial
growth factor (VEGF) inhibitors are the standard of care treatment
for advanced RCC in Europe, however, patients on current treatments
can often experience significant side effects.iv,v If approved for
use in the European Union, tivozanib would be indicated for use in
adult patients with advanced RCC who are VEGFR and mTOR pathway
inhibitor-naïve and are either untreated or who have failed prior
therapy with interferon-alpha (IFN-α) or interleukin-2 (IL-2).
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth
factor (VEGF) tyrosine kinase inhibitor (TKI). 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. Tivozanib has been investigated in
several tumors types, including renal cell, 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. 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, cachexia
(wasting syndrome) and Pulmonary Arterial Hypertension (PAH). 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,” “will,” “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 for tivozanib to be approved
by the EC as a treatment for RCC; the potential benefits of
tivozanib both as a stand-alone agent and in combination with other
therapies; AVEO’s expectations regarding the receipt of payments
under its agreement with EUSA and the potential for such payments,
if received, to favorably impact its financial condition; AVEO’s
and its collaborators’ future discovery, development and
commercialization plans and efforts, including without limitation
with respect to tivozanib, ficlatuzumab and AVEO’s other programs
and platforms; and AVEO’s strategy, prospects, plans and
objectives. 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 agreements,
and its ability, and the ability of its licensees and other
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 without limitation
risks relating to the ability of EUSA to successfully obtain
approval of tivozanib from the EC. 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.
i Cancer Research UK. Kidney Cancer, Types and Grades. Available
at:
http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades.
Last accessed May 2017.ii Cancer Research UK. Kidney Cancer
Statistics. Available at:
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/mortality#heading-Five.
Last accessed May 2017.iii Cancer Research UK. Kidney cancer rates
are increasing, so what’s fuelling the surge? Available at:
http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/.
Last accessed May 2017.iv Motzer R.J; Nosov D et al. Tivozanib
Versus Sorafenib As Initial Targeted Therapy for Patients With
Metastatic Renal Cell Carcinoma: Results From a Phase III Trial.
Journal of Clinical Oncology. Volume 31. 2013: 30:3791v Wong MKK,
Mohamed AF et al. Selecting renal cell carcinoma therapy: Ranking
of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012
(suppl; abstr 4608)
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version on businesswire.com: http://www.businesswire.com/news/home/20170623005270/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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