Sunesis Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Application for Vosaroxin in AM...
January 04 2016 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the European Medicines Agency (EMA) has validated the Marketing
Authorization Application (MAA) for vosaroxin as a treatment for
relapsed refractory acute myeloid leukemia (AML) in patients aged
60 years and older. Validation confirms that the submission is
complete and initiates the Centralized Review process by the EMA’s
Committee for Medicinal Products for Human Use (CHMP). Under
Centralized Review, the CHMP review period is 210 days, excluding
question or opinion response periods, after which the CHMP opinion
is reviewed by the European Commission, which usually issues a
final decision on EU approval within three months. The MAA
submission will be reviewed in the Centralized Procedure, which if
authorized, provides a marketing license valid in all 28 EU member
states.
“Validation of our vosaroxin MAA begins the EMA
review process and brings us another step closer to delivering a
new treatment option to patients with relapsed refractory AML,”
said Deborah Thomas, Ph.D., Vice President, Regulatory Affairs
and Medical Writing. “Following encouraging interactions with the
agency last summer, we look forward to progressing to the next
stage of the review process, which includes the 120-day questions
following the assessment report by the CHMP.”
“We believe European marketing authorization
would represent a significant opportunity both commercially and in
providing regulatory validation for other geographies around the
world,” said Daniel Swisher, Chief Executive Officer of Sunesis.
“We look forward to providing more updates in 2016 as we move
forward with this regulatory process."
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 AML
AML is a rapidly progressing cancer of the blood
characterized by the uncontrolled proliferation of immature blast
cells in the bone marrow. It is estimated that the prevalence of
AML across major global markets (U.S., France, Germany, Italy,
Spain, United Kingdom and Japan) is over 75,000. AML is generally a
disease of older adults, and the median age of a patient diagnosed
with AML is about 67 years. AML patients with relapsed or
refractory disease and newly diagnosed AML patients over 60 years
of age with poor prognostic risk factors typically die within one
year, resulting in an acute need for new treatment options for
these patients.
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 and is currently 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. In addition, the company is advancing its
kinase-inhibitor pipeline of novel targeted therapies into the
clinic.
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.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Jul 2023 to Jul 2024