Sunesis Pharmaceuticals Receives European Orphan Drug Designation for Vosaroxin to Treat Acute Myeloid Leukemia
May 03 2012 - 6:00AM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the European Commission has granted orphan drug designation to
vosaroxin, the Company's lead development candidate, for the
treatment of acute myeloid leukemia (AML). The designation provides
for 10 years of marketing exclusivity in all EU member countries
following product approval. Vosaroxin has previously received
orphan drug and fast track designations from the U.S. Food and Drug
Administration (FDA).
"The European Commission's decision reinforces the global
potential of vosaroxin and recognizes the desperate need for new
treatment options in AML, an indication for which treatment
standards have not changed appreciably in the past thirty years,"
said Dr. Adam Craig, EVP Development & CMO of Sunesis.
"European orphan drug designation is the latest in a series of
regulatory milestones that have strengthened the commercial
opportunity for vosaroxin on both sides of the Atlantic. These
include the potential for market exclusivity to 2030 and an
expedited review process in the U.S., as well as new patents issued
in the European Union with exclusivity to 2025."
As established by the European Medicines Agency (EMA), orphan
designation is granted to product candidates intended for the
treatment of a life-threatening or chronically debilitating
condition affecting no more than five in 10,000 persons in the
European Union. It also provides for scientific advice and
regulatory assistance from the EMA during the product development
phase, direct access to centralized marketing authorization, and
certain financial incentives for companies developing orphan drug
candidates. Orphan drugs are eligible for a reduction of fees
associated with pre-authorization inspections, as well as marketing
authorization application fees and certain other fees for
qualifying companies.
Sunesis is currently enrolling patients in its 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 "following,"
"provides," "potential," 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, 2011 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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