Sunesis Pharmaceuticals Announces European Medicines Agency Acceptance of Pediatric Investigation Plan for Qinprezo(TM) (Vosa...
July 09 2014 - 7:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the Pediatric Committee of the European Medicines Agency (EMA) has
issued a positive opinion on the Company's Pediatric Investigation
Plan (PIP) for Qinprezo™ (vosaroxin), Sunesis' lead drug candidate.
Sunesis is currently conducting the VALOR trial, a pivotal Phase 3,
randomized, double-blind, placebo-controlled clinical trial in
patients with first relapsed or refractory acute myeloid leukemia
(AML).
A PIP is part of the EMA approval process and must be accepted
prior to submission of a Marketing Authorization Application (MAA)
for the drug in the European Union. A PIP describes how a company
intends to evaluate the use of a given drug in children. Completion
of studies outlined in the PIP prior to European Union approval is
not a requirement for MAA submission if deferral for completion has
been received.
"We are pleased with the acceptance of our PIP by the EMA, an
important step leading into a potential filing of our Marketing
Authorization Application for Qinprezo in Europe," said Daniel
Swisher, Chief Executive Officer of Sunesis. "AML remains a
significant unmet medical need, one which has seen little
innovation in the last 40 years. We look forward to
understanding Qinprezo's potential within first relapsed or
refractory AML with the unblinding of VALOR expected in the third
or fourth quarter of 2014."
About Qinprezo™ (vosaroxin)
Qinprezo™ (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. Preclinical data
demonstrate that Qinprezo 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 Qinprezo for the treatment of
AML. Additionally, Qinprezo has been granted fast track designation
by the FDA for the potential treatment of relapsed or refractory
AML in combination with cytarabine. Qinprezo 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. The American Cancer Society estimates there will be
approximately 18,860 new cases of AML and approximately 10,460
deaths from AML in the U.S. in 2014. Additionally, it is estimated
that the prevalence of AML across major global markets (U.S.,
France, Germany, Italy, Spain, United Kingdom and Japan) is over
50,000. 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 treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to advancing its lead product candidate, Qinprezo, 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' overall strategy, the
design, conduct, progress, timing and results of the VALOR trial
and Sunesis' other clinical trials and the commercial potential for
Qinprezo™ (vosaroxin). Words such as "anticipate," "approximately,"
"believe," "could," "estimate," "expect," "potential," "remain,"
"transform," 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, risks
related to Sunesis' need for substantial additional funding to
complete the development and commercialization of Qinprezo, risks
related to whether outstanding warrants will be exercised in the
future, 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 Qinprezo, the risk that
raising funds through lending arrangements may restrict our
operations or produce other adverse results, the risk that Sunesis'
development activities for Qinprezo could be otherwise halted or
significantly delayed for various reasons, the risk that Sunesis'
clinical studies for Qinprezo 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, European Commission or other
regulatory agencies, risks related to the conduct of Sunesis'
clinical trials, risks related to the manufacturing of Qinprezo and
supply of the active pharmaceutical ingredients required for the
conduct of Sunesis' clinical trials, the risk of third party
opposition to granted patents related to Qinprezo, and the risk
that Sunesis' proprietary rights may not adequately protect
Qinprezo. 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, 2013, Sunesis' Quarterly Report on Form
10-Q for the quarter ended March 31, 2014, 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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