Company Also Announces Executive Management Team
Changes
Dr. Adam R. Craig to Step Down as Chief Medical
Officer Following Transition Period
Jennifer Smith Appointed Vice President,
Biometrics
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that
the company intends to submit a Marketing Authorization Application
(MAA) for vosaroxin as a treatment for acute myeloid leukemia (AML)
with the European Medicines Agency (EMA) by the end of 2015.
The company recently announced that it met separately with the
Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands)
assigned to provide advice and guidance to the company through the
MAA process. Based on these discussions, the company is proceeding
with an MAA filing for the indication of relapsed/refractory AML in
patients age 60 years and older, a population with the greatest
medical need and for whom the greatest benefit was observed in the
vosaroxin/cytarabine treatment arm of VALOR, the company's pivotal
Phase 3 study of vosaroxin and cytarabine in adult patients with
relapsed or refractory AML.
"The filing of an MAA for vosaroxin in Europe by year end is our
top corporate priority. As for the U.S., we are refining a plan to
find a timely path towards market," said Daniel Swisher, Chief
Executive Officer of Sunesis. "With these efforts underway, we also
expect to achieve meaningful progress in our kinase inhibitor
pipeline, including data presentations at the upcoming November
AACR-NCI-EORTC Conference in Boston. Among those being
highlighted at the conference is our second generation,
differentiated BTK program, SNS-062."
Sunesis also announced today changes to the executive management
team. Chief Medical Officer, Adam R. Craig will step down from his
role at the end of the year to pursue other opportunities.
Dr. Craig will remain available to the company on an advisory
basis throughout the regulatory process with the EMA. Also
within the Development group, Jennifer A. Smith has been appointed
Vice President of Biometrics, where her responsibilities include
the statistical design of the company's clinical trials as well as
clinical data analyses and presentations, including those
supporting ongoing regulatory filings. Dr. Smith joined
Sunesis in 2012 from BiPar Sciences where she was Senior Director
of Biometrics. Prior to BiPar, she served in similar roles at
Geron, Pharmacyclics and Aviron.
Mr. Swisher added: "We thank Adam for his leadership and
significant contributions at Sunesis as Chief Medical Officer and
look forward to continuing to work with him as a valued advisor in
2016. We have begun a search to complement our experienced
internal team with additional clinical development expertise."
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 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 that there
will be approximately 20,830 new cases of AML and approximately
10,460 deaths from AML in the U.S. in 2015. 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 75,000. 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 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 June 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
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