LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 14, 2008-- Synta Pharmaceuticals Corp., (NASDAQ: SNTA) a biopharmaceutical
company focused on discovering, developing, and commercializing small
molecule drugs to treat severe medical conditions, today announced
that it has achieved operational milestones triggering $25 million in
payment from GlaxoSmithKline (GSK) under its collaboration agreement
for the development and commercialization of elesclomol.
Elesclomol is a novel, oxidative stress inducing, small molecule
drug candidate currently undergoing Phase 3 clinical investigation in
metastatic melanoma, the SYMMETRY(SM) trial, with other trials in
other indications planned. Elesclomol is not yet approved for any
indication in any market.
Synta is eligible to earn a further $25 million in operational
milestone payments prior to completion of enrollment of the SYMMETRY
trial. Following enrollment completion and analysis of the primary
endpoint data, Synta is eligible for an additional $25 million
milestone payment if the trial meets the primary endpoint or if Synta
and GSK agree to file for regulatory approval.
In total, including the above $75 million in received or near-term
potential payments, the collaboration agreement calls for $585 million
in development and regulatory milestone payments related to melanoma
($145 million) and other cancer indications ($440 million).
Collaboration with GlaxoSmithKline
In October 2007, Synta and GSK entered into a collaboration
agreement for elesclomol. Under the terms of the agreement, the
companies will jointly develop and commercialize elesclomol in the
U.S. and GSK will have exclusive responsibility for development and
commercialization of elesclomol outside the U.S.
Synta and GSK are working closely together to further the clinical
development of elesclomol as well as prepare for the manufacture and
commercial launch of elesclomol.
About Elesclomol
Elesclomol is a novel, injectable, investigational drug candidate
that triggers apoptosis (programmed cell death) in cancer cells.
Cancer cells operate at high levels of reactive oxygen species, or
oxidative stress. Elesclomol acts by increasing the level of oxidative
stress in cancer cells even further, beyond sustainable levels,
inducing apoptosis. This mechanism of action, called oxidative stress
induction, represents a novel way of selectively targeting and killing
cancer cells.
In a double-blind, randomized, controlled Phase 2b clinical trial
in 81 patients with stage IV metastatic melanoma, elesclomol in
combination with paclitaxel met the primary endpoint, doubling the
median time patients survived without their disease progressing,
compared to paclitaxel alone (p = 0.035). The most common adverse
events in the elesclomol plus paclitaxel group included fatigue,
alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia,
diarrhea, and anemia.
A pivotal Phase 3 clinical trial of elesclomol in combination with
paclitaxel in patients with stage IV metastatic melanoma (the
SYMMETRY(SM) trial) is ongoing; Phase 2 trials in other indications,
and in combination with other agents, are planned. Elesclomol has
received Fast Track and Orphan Drug designation from the FDA for
metastatic melanoma, and the Phase 3 SYMMETRY trial has completed a
Special Protocol Assessment process with the FDA. Information about
the SYMMETRY trial can be found at www.symmetrymelanomastudy.com, or
www.clinicaltrials.gov.
About Metastatic Melanoma
Melanoma, the most deadly form of skin cancer, arises from
melanocytes, the pigment-producing cells of the skin. According to the
American Cancer Society, melanoma accounts for approximately five
percent of all skin cancers but causes about 75% of all skin
cancer-related deaths. An estimated 60,000 people will be diagnosed
and nearly 8,200 people will die from melanoma this year in the U.S.
alone. If diagnosed and surgically removed while localized in the
outermost skin layer, melanoma is potentially curable; however, for
patients with metastatic disease the prognosis is poor, with limited
available treatments and an expected survival of only six to nine
months. The incidence of melanoma has increased more rapidly than any
other cancer during the past ten years. The FDA has not approved a
novel, small molecule drug for the treatment of metastatic melanoma in
over 30 years.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused
on discovering, developing, and commercializing small molecule drugs
to extend and enhance the lives of patients with severe medical
conditions, including cancer and chronic inflammatory diseases. Synta
has a unique chemical compound library, an integrated discovery
engine, and a diverse pipeline of clinical- and preclinical-stage drug
candidates with distinct mechanisms of action and novel chemical
structures. All Synta drug candidates were invented by Synta
scientists using our compound library and discovery capabilities. For
more information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. Such forward-looking statements can be
identified by the use of forward-looking terminology such as "will",
"would", "should", "expects", "anticipates", "intends", "plans",
"believes", "may", "estimates", "predicts", "projects", or similar
expressions intended to identify forward-looking statements. Such
statements, including statements relating to the timing and progress
of our clinical and preclinical programs, the timing and amounts of
milestone payments under our agreement with GSK and financial guidance
for 2008, reflect our current views with respect to future events and
are based on assumptions and subject to risks and uncertainties that
could cause actual results to differ materially from those expressed
or implied by such forward-looking statements, including those
described in "Risk Factors" of our Form 10-K for the year ended
December 31, 2007 as filed with the Securities and Exchange
Commission. Synta undertakes no obligation to publicly update
forward-looking statements, whether because of new information, future
events or otherwise, except as required by law.
Source: Synta Pharmaceuticals Corp.
