LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 17, 2009--
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 an operational milestone triggering a $10 million payment from
GlaxoSmithKline (GSK) under its collaboration agreement for the
development and commercialization of elesclomol.
Elesclomol is an investigational first-in-class oxidative stress inducer
that triggers apoptosis (programmed cell death) in cancer cells.
Elesclomol is currently being studied in combination with paclitaxel in
a Phase 3 clinical trial (SYMMETRY(SM)) in metastatic
melanoma which completed enrollment earlier this month. Elesclomol is
not yet approved for any indication in any market.
Synta has earned a total of $130 million in payments from GSK to date,
including the $80 million upfront payment in 2007, $40 million for
milestones achieved in 2008 and the $10 million announced today for the
achievement of a melanoma-related operational milestone. Under the
collaboration agreement with GSK, Synta is eligible for a total of $585
million in pre-commercial milestone payments, of which $50 million have
been paid to date, $100 million are related to additional progress in
melanoma, and the remainder is related to progress in other cancer
indications. In additional to the pre-commercial milestone payments,
Synta is eligible for $300 million in sales milestones, 40-50% share of
operating profits in the United States, and double-digit royalties on
sales outside the United States.
About Elesclomol
Elesclomol is an investigational first-in-class oxidative stress inducer
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
trial) has completed enrollment; a Phase 1/2 trial in hormone-refractory
prostate cancer, in combination with docetaxel, is ongoing. A Phase 1
monotherapy trial in solid tumors was recently initiated and Phase 2
trials in other indications, and in combination with other agents, are
planned.
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 is responsible for the SYMMETRY Phase
3 melanoma study and the filing of the New Drug Application with the FDA.
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 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, and the timing and amounts of milestone
payments under our agreement with GSK, 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.
Synta Pharmaceuticals Corp.
Rob Kloppenburg, 781-541-7125
or
MacDougall
Biomedical Communications
Doug MacDougall, 781-235-3060
