Sunesis Pharmaceuticals Announces European Patent Covering Vosaroxin Combination Use in AML and Other Hematologic Malignancie...
November 30 2015 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the European Patent Office (EPO) has granted European Patent No. 2
049 109 B1, claiming certain combined uses of vosaroxin and
cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2,
respectively, for the treatment of acute myelogenous leukemia and
acute myeloblastic leukemia. The patent further provides for
combinations of vosaroxin and cytarabine with other therapies, such
as radiation, or other chemotherapeutics, including anti-cancer
agents, in hematologic disorders, whether administered
simultaneously or sequentially. Sunesis is proceeding to validate
this patent in multiple EPO member states. The resulting national
patents would expire in the third quarter of 2027, but could be
eligible for supplementary patent term in EPO member states beyond
this date. Related patent applications are pending in several
countries, including the United States and Japan.
"This patent adds important value to a European commercial
opportunity for vosaroxin, as it covers a wide range of its
contemplated commercial use with cytarabine out to 2027," said Eric
Bjerkholt, Executive Vice President, Corporate Development and
Finance of Sunesis. "Granting of this European patent is
particularly timely, as we prepare to file a European Marketing
Authorization Application for vosaroxin in combination with
cytarabine in AML by year end. It also provides us with greater
certainty in pursuing the full clinical and commercial potential of
vosaroxin using various therapeutic combinations in AML and other
hematologic malignancies."
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' estimated timelines for
regulatory interactions and regulatory progress, including the
anticipated submission of the MAA for vosaroxin with the EMA and
plans to gain marketing approval of vosaroxin in the U.S., Sunesis'
overall strategy, the design, conduct and results of clinical
trials, including the expected progress in its kinase inhibitor
pipeline, estimated new cases of AML, its prevalence across major
global markets, prognosis for patients with AML, the need for and
the role of vosaroxin as a potential new treatment option, and
Sunesis' clinical development of vosaroxin, including the analysis
of the results from the VALOR clinical trial. Words such as
"anticipates," "estimates," "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 may not be able
to submit timely the MAA to the EMA, the risk that Sunesis'
clinical studies for vosaroxin may not lead to regulatory approval
in the U.S. or Europe, that Sunesis' development activities for
vosaroxin could be otherwise halted or significantly delayed for
various reasons, the risk that Sunesis' clinical studies for
vosaroxin or other 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
Sunesis Pharmaceuticals (NASDAQ:SNSS)
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