Sunesis Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Vo...
October 13 2016 - 3:05PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it
has submitted its responses to European Medicines Agency (EMA) Day
120 List of Questions 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
vosaroxin as a treatment for relapsed/refractory acute myeloid
leukemia (AML) in patients aged 60 years and older. Sunesis expects
to receive the EMA Day 180 List of Outstanding Issues before
year-end.
“We are pleased with the comprehensive set of
answers and additional analyses that our team has provided in
response to the EMA’s Day 120 list of questions,” said Daniel
Swisher, President and Chief Executive Officer of Sunesis. “As our
regulatory efforts progress to bring vosaroxin to market
in Europe as a treatment for relapsed/refractory AML, we
are advancing active dialogues with potential pharma collaborators
toward the goal of supporting a market launch in 2017. With the
clock now restarting, we anticipate being one step closer to that
goal.”
About QINPREZO™ (vosaroxin)QINPREZO™
(vosaroxin) is an anti-cancer quinolone derivative (AQD), a class
of compounds that has not been used previously for the treatment of
cancer. Preclinical data demonstrate that vosaroxin both
intercalates DNA and inhibits topoisomerase II, resulting in
replication-dependent, site-selective DNA damage, G2 arrest and
apoptosis. Both the U.S. Food and Drug
Administration (FDA) and European Commission have
granted orphan drug designation to vosaroxin for the treatment of
AML. Vosaroxin is an investigational drug that has not been
approved for use in any jurisdiction.
Vosaroxin’s Marketing Authorization Application
for relapsed refractory AML is currently under review by
the European Medicines Agency, and a regulatory decision
regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name
for the vosaroxin drug product candidate.
About Sunesis PharmaceuticalsSunesis is a
biopharmaceutical company focused on the development and
commercialization of new oncology therapeutics for the potential
treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to improving the lives of people with cancer. Currently, the
company is focused on pursuing regulatory approval
in Europe for its lead product candidate, vosaroxin, for
the treatment of relapsed or refractory acute myeloid leukemia in
patients aged 60 and older, as well as advancing its novel
kinase-inhibitor pipeline, which includes its proprietary
non-covalent BTK-inhibitor, SNS-062. For additional
information on Sunesis, please
visit http://www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to Sunesis' corporate
objectives, including the regulatory development and potential
approval of vosaroxin by the EMA, potential collaborations and
ability to commercialize vosaroxin in Europe. Words such as
“expect,” “goal,” “may,” "potential" “advancing,” “anticipate,”
“progress” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Sunesis' current expectations. Forward-looking
statements involve risks and uncertainties. Sunesis' actual results
and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, the
risk that Sunesis may not be able to receive regulatory approval of
vosaroxin in the U.S. or Europe, that Sunesis' development
activities for vosaroxin could be otherwise halted or significantly
delayed for various reasons, risks related to Sunesis' need for
substantial additional funding to complete the development and
commercialization of vosaroxin and other product candidates, the
risk that Sunesis' clinical studies for SNS-062, vosaroxin or other
product candidates, including its pipeline of kinase inhibitors,
may not demonstrate safety or efficacy or lead to regulatory
approval, the risk that data to date and trends may not be
predictive of future data or results, risks related to the conduct
of Sunesis' clinical trials, and risks related to Sunesis' ability
to raise the capital that it believes to be accessible and is
required to fully finance the development and commercialization of
vosaroxin and other product candidates. These and other risk
factors are discussed under "Risk Factors" and elsewhere in
Sunesis' Annual Report on Form 10-K for the year
ended December 31, 2015, Sunesis’ Quarterly Report on Form
10-Q for the quarter ended June 30, 2016, and Sunesis' other
filings with the Securities and Exchange Commission.
Sunesis expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Sunesis'
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Sunesis Pharmaceuticals (NASDAQ:SNSS)
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