Sunesis Pharmaceuticals Announces Submission of Responses to the EMA Day 180 List of Outstanding Issues for Marketing Authori...
March 22 2017 - 07:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it
has submitted its responses to the European Medicine Agency (EMA)
Day 180 List of Outstanding Issues issued by the Committee for
Medicinal Products for Human Use (CHMP) as part of the centralized
review process of the Marketing Authorization (MAA) for vosaroxin
as a treatment for relapsed/refractory acute myeloid leukemia (AML)
in patients aged 60 years and older.
“Our team has provided detailed answers to the
EMA in response to the Day 180 List of Outstanding Issues,” said
Daniel Swisher, President and Chief Executive Officer of Sunesis.
“We are preparing to go before the Scientific Advisory Group’s
Oncology Division (SAG-O) in April, which will assist the CHMP in
its evaluation of our application. As we approach this final phase
of the European approval process, anticipating a CHMP decision by
mid-year, we continue to work in parallel to qualify the best
pharma partner to work with us on a European market launch of
vosaroxin in the second half of 2017.”
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. Additionally, vosaroxin has been granted fast track
designation by the FDA for the potential treatment of
relapsed/refractory AML in combination with cytarabine. 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
Pharmaceuticals
Sunesis 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, the regulatory development, Sunesis’ response to Day
180 List of Outstanding Issues and the anticipated timing of a CHMP
decision, and potential approval of vosaroxin by the EMA, potential
collaborations and ability to commercialize vosaroxin
in Europe. Words such as “advancing,” “anticipate,” “expect,”
"potential,” “will” 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 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, 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
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