Sunesis Appoints Joseph I. DePinto as Chief Commercial Officer, Updates VALOR Timeline to Unblinding of Data
SOUTH SAN FRANCISCO, Calif., Feb. 10, 2014 (GLOBE NEWSWIRE) -- Sunesis
Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the appointment of
Joseph I. DePinto to the newly created position of Executive Vice
President and Chief Commercial Officer. Mr. DePinto brings over two
decades of experience in global commercial operations, including the
leadership of the commercial, marketing and strategic development
efforts behind a number of prominent oncology products.
"Joe's extensive commercial leadership and expertise in overseeing
launch, growth and lifecycle planning of leading oncology products
provide immediate leverage to Sunesis as we approach the unblinding of
VALOR and prepare to execute successfully on our commercial and
regulatory strategies for vosaroxin," said Daniel Swisher, Chief
Executive Officer of Sunesis. "A key element of our commercialization
planning process was to conduct a comprehensive search for an
experienced, passionate commercial leader to help realize vosaroxin's
and the company's full potential. Joe more than meets these criteria,
and we look forward to his contributions."
Sunesis also announced today that, based on a recent evaluation of
survival events, the unblinding of the pivotal, Phase 3 VALOR trial of
vosaroxin plus cytarabine in first relapsed or refractory acute myeloid
leukemia (AML) is now expected in the third quarter of 2014.
Mr. Swisher added: "With survival events occurring at a slower pace
than previously forecast, we now expect to unblind VALOR in the third
quarter of 2014, rather than the second quarter. We remain well funded
to prosecute VALOR beyond the transformative milestone of top-line data
"Vosaroxin is an exciting product candidate, one with significant
potential in AML and other related indications, to which Sunesis has
retained full global commercial rights," said Mr. DePinto. "I am
delighted to join Sunesis at this exciting time to help lead the
forward integration of the company with a build out of a preeminent
U.S. oncology commercial team to successfully introduce vosaroxin into
a population desperately in need of new therapies."
Prior to joining Sunesis, Mr. DePinto was Executive Vice President,
Global Commercial Operations at Dendreon Corporation, where he was
responsible for all sales, marketing, and market access teams in the
U.S. and globally. Prior to Dendreon, Mr. DePinto was Vice President
and Product Champion for ImClone Systems (Eli Lilly and Company), and
previously served as Vice President, U.S. sales and marketing at
Abraxis Bioscience. Prior to that, Mr. DePinto served as Vice
President, commercial operations at ImClone Systems; global Marketing
Leader, Oncology Therapeutics for Johnson & Johnson Pharmaceutical
Services Inc.; and Vice President, oncology sales at Ortho Biotech
Products. Mr. DePinto earned his Bachelor of Science in Marketing and
MBA in Pharmaceutical Chemical Studies from Fairleigh Dickinson
VALOR is a Phase 3, randomized, double-blind, placebo-controlled,
pivotal trial in patients with first relapsed or refractory AML. The
trial enrolled 712 patients at more than 100 leading sites in the U.S.,
Canada, Europe, Australia, New Zealand and South Korea. Patients were
randomized in a ratio of 1:1 to receive either vosaroxin on days one
and four in combination with cytarabine daily for five days, or placebo
in combination with cytarabine. The trial's primary endpoint is overall
survival. For more information on the VALOR trial, please visit
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. Both the U.S. Food and Drug Administration (FDA)
and European Commission have granted orphan drug designation to
vosaroxin for the treatment of acute myeloid leukemia (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.
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.
This press release contains forward-looking statements, including
statements related to the design, conduct, progress, timing and results
of the VALOR trial and Sunesis' investigator sponsored trials, and the
commercial potential for vosaroxin. Words such as "anticipate,"
"believe," "expect," "forecast," "leverage," "look forward,"
"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 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 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, European Commission 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 Sunesis'
clinical trials, 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' Annual Report
on Form 10-K for the year ended December 31, 2012, Sunesis' Quarterly
Report on Form 10-Q for the quarter ended September 30, 2013 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.
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