AVEO Announces Appointment of Nikhil Mehta, Ph.D., as Senior Vice President of Regulatory and Quality Assurance
November 20 2017 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ: AVEO) today announced the appointment of
Nikhil Mehta, Ph.D., as Senior Vice President of Regulatory and
Quality Assurance, effective November 20, 2017. In this role, Dr.
Mehta will oversee all aspects of regulatory, quality and technical
operations for the company’s portfolio. Dr. Mehta brings to AVEO
more than 25 years of experience in the biotechnology and
pharmaceutical industries, having played a key role in the
development and approval of important therapeutic products in the
areas of oncology and orphan disease.
“Dr. Mehta brings to AVEO a depth of experience in regulatory
affairs and oncology that we believe will be invaluable as we plan
and advance our U.S. registration strategy for tivozanib as a
potential treatment for renal cell carcinoma,” said Michael Bailey,
president and chief executive officer of AVEO. “Over the course of
his career with companies such as Baxalta, Merck, Shire and ImClone
Systems, Dr. Mehta’s experience includes the development and
execution of global regulatory strategies leading to the approval
of a number of important oncology therapeutics including KEYTRUDA®
(pembrolizumab) and ERBITUX® (cetuximab). I anticipate his
integration into the AVEO team will be seamless and rapidly
productive. In the very near term, we look forward to working with
Dr. Mehta through the announcement of topline data from the pivotal
TIVO-3 trial, which we anticipate in the first quarter of 2018,
potentially followed by a U.S. regulatory filing in the second half
of 2018.”
“The AVEO team has made outstanding progress in advancing an
important, differentiated therapeutic in tivozanib, including
executing a confirmatory pivotal study, working alongside a partner
to secure European marketing registration and initiating a new
immunotherapy combination study,” said Dr. Mehta. “I look forward
to contributing to the next stages of this progress by leveraging
my expertise and experience to help ensure AVEO’s successful
transition to a global commercial entity."
Most recently, Dr. Mehta served as Executive Vice President and
Chief Regulatory Strategist at Tang Capital Management, where he
played a key role in the establishment of two biopharmaceutical
companies, Odonate Therapeutics and Sentier Therapeutics. Prior to
Tang Capital, Dr. Mehta served as Global Head of Regulatory Affairs
at Baxalta, a period during which the company gained approval for
ADYNOVATE®, VONVENDI®, and OBIZUR. Prior to Baxalta, he was Vice
President, Global Regulatory Affairs, Oncology, Hematology,
Immunology and Diagnostics, at Merck & Company, where, among
other accomplishments, he played a key role in the rapid
development and first approval of Merck’s blockbuster checkpoint
inhibitor, KEYTRUDA. Prior to Merck, Dr. Mehta held positions of
increasing responsibility within regulatory affairs at Shire HGT,
ImClone Systems, Bristol-Myers Squibb and Hoffmann-La Roche, where
he played key roles in the approvals of ELAPRASE®, VPRIV®, FIRAZYR®
and ERBITUX. Dr. Mehta holds a Ph.D. in Chemical and Biochemical
Engineering from Rutgers University.
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: clinical, regulatory and commercial plans
of AVEO and its partner EUSA Pharma with respect to tivozanib
(FOTIVDA®); the expected timeline for reporting data from TIVO-3
and TiNivo; the role and expected benefits of tivozanib and other
TKIs on a stand-alone basis, or in combination with or following
immunotherapy; the expected enrollment of the TiNivo trial;
expectations about the potential for additional payments by EUSA
Pharma; the value of AVEO's partnerships in advancing its pipeline;
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 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 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.
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Argot Partners for AVEODavid Pitts,
212-600-1902aveo@argotpartners.com
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