Sunesis Pharmaceuticals Announces Notice of Allowance for U.S. Patent Application Covering Vosaroxin Compositions
February 14 2012 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the U.S. Patent and Trademark Office (USPTO) issued a Notice of
Allowance for U.S. Patent Application No. 12/982,785 claiming
certain compositions related to Sunesis' lead drug candidate,
vosaroxin. The patent will grant Sunesis exclusive rights to
certain Active Pharmaceutical Ingredient compositions of vosaroxin,
as well as the final product related to such compositions, and
provides patent exclusivity to mid 2030 in the United States. A
family of corresponding patent applications are pending in the U.S.
and internationally.
"The '785 patent is an important aspect of our intellectual
property estate. Once granted, the patent will provide significant
additional patent protection and support market exclusivity for
vosaroxin out nearly two decades to 2030," stated Daniel Swisher,
Chief Executive Officer of Sunesis. "The successful pursuit of this
patent is another step in our intellectual property strategy, a
strategy which provides Sunesis with greater certainty in pursuing
the full clinical and commercial potential of vosaroxin. We look
forward to additional important milestones for vosaroxin this year,
including an interim analysis of the Phase 3 VALOR trial."
Sunesis is currently enrolling patients with more than 110
active sites open in 14 countries in the VALOR trial, a Phase 3,
multinational, randomized, double-blind, placebo-controlled,
pivotal clinical trial of vosaroxin in combination with cytarabine
in first relapsed or refractory acute myeloid leukemia.
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial is expected to enroll 450 evaluable
patients at approximately 110 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial is currently
enrolling patients, who are randomized one to one to receive either
vosaroxin on days one and four in combination with cytarabine daily
for five days, or placebo in combination with cytarabine.
Additionally, the VALOR trial employs an innovative, adaptive trial
design that allows for a one-time sample size adjustment by the
DSMB at the interim analysis to maintain adequate power across a
broader range of survival outcomes. The trial's primary endpoint is
overall survival. For more information on the VALOR trial, please
visit www.valortrial.com.
The VALOR logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8774.
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative,
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Vosaroxin both intercalates DNA and
inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the 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.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
This press release contains forward-looking statements,
including statements related to the exclusivity period for
vosaroxin in the United States and other geographies and the
design, conduct and results of the VALOR trial and the occurrence
and timing of the DSMB interim analysis. Words such as "will,"
"provides," "pending," "expected" 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 results of these risks and
uncertainties, which include, without limitation, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin, 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, the risk that raising funds through
lending arrangements may restrict our operations or produce other
adverse results, the risk that Sunesis' development activities for
vosaroxin could be otherwise halted or significantly delayed for
various reasons, the risk that Sunesis' clinical studies for
vosaroxin 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, the risk that Sunesis'
nonclinical studies and clinical studies may not satisfy the
requirements of the FDA or other regulatory agencies, risks related
to the conduct of Sunesis' clinical trials, risks related to the
manufacturing of vosaroxin and supply of the active pharmaceutical
ingredients required for the conduct of the VALOR trial, the risk
of third party opposition to granted patents related to vosaroxin,
and the risk that Sunesis' proprietary rights may not adequately
protect 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, 2011, Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2010 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 the company's
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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