LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 12, 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 $15 million in payments 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
an on-going Phase 3 clinical trial (SYMMETRYSM) in metastatic
melanoma. Synta also recently initiated a Phase 1/2 clinical trial of
elesclomol in combination with docetaxel in hormone refractory
metastatic prostate cancer with trials in other indications planned for
2009. Elesclomol is not yet approved for any indication in any market.
Under the terms of the collaborative agreement with GSK, Synta is
eligible for a total of $585 million in pre-commercial milestone
payments. These miletsones are related to operational progress, clinical
progress, or regulatory filings and outcomes in melanoma and other
cancer indications:
-- $145 million in melanoma-related operational and regulatory milestones,
including:
o $25 million for milestones achieved and announced previously;
o $10 million for milestones achieved and announced today;
o $10 million for additional milestones expected prior to completion of
enrollment;
o $25 million upon meeting the primary endpoint or agreement to file for
regulatory approval; and
o $75 million in potential milestone payments for melanoma regulatory
filings and approvals.
-- $440 million in milestone payments for clinical and regulatory progress
in other cancer indications, including;
o $5 million in milestones announced today.
In addition to the above 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. Synta has earned a total of $120 million in
payments from GSK to date, including the $80 million up front payment in
2007 and the $40 million to date in 2008.
As previously announced, Synta expects to complete enrollment in the
Phase 3 SYMMETRY trial in January or February of 2009 and conduct the
primary endpoint analysis for progression- free survival shortly
thereafter.
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 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 SYMMETRYSM
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, (NCI identifier # NCT00522834).
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 and 2009, 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.
CONTACT: Synta Pharmaceuticals Corp.
Rob Kloppenburg, 781-541-7125
or
MacDougall Biomedical Communications
Doug MacDougall, 781-235-3060
Source: Synta Pharmaceuticals Corp.
