AVEO Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Tivoz...
November 28 2016 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced that its development
partner, EUSA Pharma, a specialty pharmaceutical company with a
focus on oncology and oncology supportive care, has submitted its
responses to the European Medicines Agency (EMA) Day 120 List of
Questions. The Day 120 List of Questions were issued by the
Committee for Medicinal Products for Human Use (CHMP) as part of
the centralized review process of the Marketing Authorization
Application (MAA) for tivozanib for the first-line treatment of
advanced renal cell carcinoma (RCC). The next step in the filing
process, the EMA Day 180 List of Outstanding Issues, is expected in
the first quarter of 2017.
“This submission represents an important step forward in working
toward an anticipated first half 2017 European approval decision,
one of three potential key tivozanib-related milestones during this
period,” said Michael Bailey, president and chief executive officer
of AVEO. “Given tivozanib’s unique activity and safety profile, we
believe the first line RCC market in Europe represents a meaningful
commercial opportunity, and we look forward to working with EUSA
Pharma to fully elucidate this potential. In addition to a
potential European approval decision, we expect to have initial
results from the Opdivo® combination TiNivo study in RCC and may
see milestones from Ophthotech for tivozanib in acute macular
degeneration in the first half of 2017.”
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
developing and commercializing 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 to develop and commercialize 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.
AVEO 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,” “seek,” 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: plans and strategies of AVEO and its partners and the
potential achievement by AVEO and its partners of clinical,
regulatory, manufacturing and other development goals and
milestones; AVEO’s expectations regarding a registration decision
in the EU for tivozanib, including timing thereof; the timing of
enrollment and data readouts from the TiNivo trial; the commercial
opportunity for tivozanib in the first line RCC market in Europe;
the potential safety, efficacy, tolerability and other benefits of
tivozanib in the treatment of renal cell carcinoma as a single
agent or in combination with other therapies; and the potential for
Ophthotech to achieve and pay milestones in the first half of 2017.
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; AVEO’s 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;
unplanned capital requirements; adverse general economic and
industry conditions; competitive factors; and those risks discussed
in the section titled “Risk Factors” in AVEO’s most recent Annual
Report on Form 10-K, its quarterly reports on Form 10-Q and its
other filings with the SEC. 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/20161128005222/en/
for AVEOArgot PartnersDavid Pitts, (212)
600-1902aveo@argotpartners.com
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