Sunesis Pharmaceuticals (Nasdaq:SNSS) and Royalty Pharma today
announced that Royalty Pharma has agreed to pay Sunesis $25
million, under certain circumstances related to the successful
development of Sunesis' lead product candidate vosaroxin, to
acquire a royalty on future worldwide net sales of vosaroxin.
Sunesis is evaluating vosaroxin in a pivotal Phase 3,
randomized, double-blind, placebo-controlled trial, the VALOR
trial, in patients with first relapsed or refractory acute myeloid
leukemia (AML). The VALOR trial employs an adaptive trial design
that permits a one-time increase in sample size at the interim
analysis by its Data and Safety Monitoring Board (DSMB). At the
interim analysis, expected in the third quarter of 2012, the DSMB
will examine pre-specified efficacy and safety data sets and decide
whether to stop the study early for efficacy or futility, continue
the study as planned or implement a one-time sample size adjustment
of 225 additional evaluable patients.
Under terms of the agreement, Royalty Pharma will invest $25
million immediately following VALOR's interim analysis if: (a) the
study stops early for efficacy, in exchange for a 3.6%
participation payment on future net sales; or (b) the one-time
sample size increase is being implemented, in exchange for a 6.75%
participation payment on future net sales as well as two warrants.
In the case when VALOR proceeds to its planned 450 patient
enrollment, Royalty Pharma has the option to make a $25 million
investment upon the unblinding of the study in exchange for a 3.6%
participation payment on future net sales. The warrants issued to
Royalty Pharma are exercisable if VALOR's sample size is increased
and are each to purchase 1,000,000 shares of Sunesis common stock
at an exercise price of $3.48 and $4.64 per share, respectively.
Sunesis currently holds all worldwide commercial rights to its
vosaroxin product.
"Royalty Pharma has a strong track record of identifying
significant commercial opportunities in the pharmaceutical sector.
We believe this commitment by Royalty Pharma is a validation of
vosaroxin's potential in AML and reflects the significant upside of
a positive VALOR trial," stated Daniel Swisher, Chief Executive
Officer of Sunesis.
"This innovative transaction will provide us with access to
added capital that extends our runway beyond the unblinding of
VALOR and enables our team to actively prepare for vosaroxin's
regulatory filings and US commercial launch. It will also allow us
to selectively expand our development program and enhance our
strategic flexibility on the timing and terms of vosaroxin
partnering arrangements outside the US," added Eric Bjerkholt,
Executive Vice President, Corporate Development & Finance of
Sunesis.
"Sunesis' use of an adaptive trial design offers us an
opportunity to invest in this promising biopharmaceutical product
candidate on terms that are a win-win for both Sunesis and Royalty
Pharma: Sunesis gains access to a flexible, novel financing
structure and we are able to invest in vosaroxin at a time when we
believe its likelihood of commercial success will be high," said
Pablo Legorreta, Chief Executive Officer of Royalty
Pharma. "Based on our extensive due diligence, we are
impressed with the Sunesis team, the robust preclinical and
clinical dataset for vosaroxin, as well as the rigor of the VALOR
trial design and implementation. We are pleased to be
partnering with Sunesis in this transaction, and believe that this
first-in-class compound has the potential to transform the
treatment landscape for AML and potentially other cancers."
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 more than 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.
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 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 were
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. 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, vosaroxin, in multiple
indications to improve the lives of people with cancer. For
additional information on Sunesis, please visit
http://www.sunesis.com.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
About Royalty Pharma
Royalty Pharma is the industry leader in acquiring royalty
interests in marketed and late stage biopharmaceutical products,
with royalty interests in 30 approved products (including Abbott's
Humira®, Johnson and Johnson's Remicade®, Merck's Januvia®,
Gilead's Atripla®, Truvada®, and Emtriva®, Pfizer's Lyrica®,
Amgen's Neupogen® and Neulasta®, and Genentech's Rituxan®) valued
at over $6 billion. Royalty Pharma has a fifteen year history
of providing value to holders of royalty interests, including its
$400 million purchase of 80% of Memorial
Sloan-Kettering Cancer Center's
Neupogen®/Neulasta® royalty, its $700 million acquisition of
AstraZeneca's Humira royalty, its $700 million purchase of a
portion of Northwestern University's Lyrica royalty, its $650
million purchase of New York University's Remicade royalty, its
joint $525 million acquisition with Gilead Sciences of Emory
University's emtricitabine royalty interest, and most recently its
$609 million acquisition of Astellas Pharma's patent estate and
associated royalty stream relating to the use of dipeptidyl
peptidase IV (DPP-IV) inhibitors for the treatment of type 2
diabetes.
The Royalty Pharma logo is available
at http://www.globenewswire.com/newsroom/prs/?pkgid=12228
More information on Royalty Pharma is available at
www.royaltypharma.com.
Forward Looking Statements for Sunesis
This press release contains forward-looking statements,
including statements related to the exclusivity period for
vosaroxin in the United States and other geographies, the design,
conduct and results of the VALOR trial, the occurrence and timing
of the DSMB interim analysis and whether the conditions to the
payment of the $25 million fee from Royalty Pharma will be
satisfied in a timely manner. 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 finance the development and commercialization of
vosaroxin, the risk that raising funds and providing related
security interests in our assets 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 and manufacturing may not satisfy the requirements
of the FDA or other regulatory agencies, 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" in our 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: Sunesis Contacts:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Royalty Pharma Contact:
Investor Relations
212-883-0200
ir@royaltypharma.com
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