AVEO Announces Submission of Response to Tivozanib Marketing Authorization Application Day 180 List of Outstanding Issues
April 13 2017 - 8:00AM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today announced that its European
licensee for tivozanib, EUSA Pharma, has submitted responses to the
European Medicines Agency (EMA) Day 180 List of Outstanding Issues
(LOI) related to the Marketing Authorization Application (MAA) for
tivozanib as a first-line treatment for renal cell carcinoma. With
submission of the response complete, EUSA remains tentatively
scheduled to provide an oral explanation to the EMA’s Committee for
Medicinal Products for Human Use (CHMP) at its May 2017
meeting.
“Responding to the Day 180 List of Outstanding Issues is another
important step in the tivozanib MAA, and we continue to work with
EUSA Pharma in their effort to seek regulatory approval for
tivozanib in Europe,” said Michael Bailey, president and chief
executive officer of AVEO. “This includes supporting EUSA as they
proceed toward a planned oral explanation to the CHMP in May,
while at the same time we continue to advance our registration
strategy for tivozanib in the United States. We look forward to
providing updates on these dual paths as we complete the final
phase of the European approval process and work toward our goal of
full enrollment in our U.S. registration-directed TIVO-3
study.”
As previously announced, the Day 180 LOI signified that the MAA
is not approvable at that time, and outlines outstanding
deficiencies, which are then required to be satisfactorily
addressed in an oral explanation and/or in writing prior to a final
application decision.
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 and other cancers. AVEO is
leveraging multiple partnerships aimed at developing and
commercializing tivozanib in non-oncologic indications worldwide
and oncology indications outside of North America, as well as to
progress its pipeline of novel therapeutic candidates in cancer and
cachexia (wasting syndrome). 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: EUSA’s planned meeting with CHMP in May 2017; AVEO’s
plan to provide updates on both the European and U.S. approval
process; AVEO’s plan to work toward full enrollment in its U.S.
registration-directed TIVO-3 study; plans and strategies of AVEO
and its partners and the potential for continued progress and
achievement by AVEO and its partners of clinical, regulatory, and
commercial, goals for AVEO’s other product candidates; and the
potential safety, efficacy, tolerability and other benefits of
tivozanib in the treatment of renal cell carcinoma. AVEO has based
its forward-looking statements on assumptions that may prove to be
incorrect. As a result, readers are cautioned not to place undue
reliance on these forward-looking statements. 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, including EUSA, 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 the EMA and the
FDA; AVEO’s ability to successfully enroll and complete clinical
trials, including the TIVO-3 trial; 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170413005593/en/
For AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
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