Sunesis Pharmaceuticals Announces Submission of a Marketing Authorization Application for Vosaroxin for the Treatment of Acut...
December 08 2015 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the company has submitted a Marketing Authorization Application
(MAA) with the European Medicines Agency (EMA) for Vosaroxin for
the treatment of acute myeloid leukemia in patients aged 60 years
and older. The application is subject to validation by the EMA, a
process which typically takes one month, before the formal
regulatory review of the application begins.
"Submission of an MAA for vosaroxin in relapsed refractory AML
was our top priority in 2015. This milestone brings us closer to
delivering a new option to a patient population which has seen
little improvement in treatment standards in the last 40 years,"
said Daniel Swisher, Chief Executive Officer of Sunesis. "We
believe the European market opportunity is significant, and
look forward to providing updates on our progress with the
application throughout 2016."
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 or refractory AML in combination with cytarabine.
Vosaroxin is an investigational drug that has not been approved for
use in any jurisdiction.
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 advancing its lead product candidate, vosaroxin, in
multiple indications to improve the lives of people with
cancer.
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' expected progress in its
kinase inhibitor pipeline. Words such as "may," "expect,"
"intends," "plan," "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' clinical studies for its product candidates 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, risks related to Sunesis' need for substantial additional
funding to complete the development and commercialization of
vosaroxin, 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. These
and other risk factors are discussed under "Risk Factors" and
elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter
ended September 30, 2015. 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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