EXHIBIT 99.1
ARIAD Initiates Phase 3 'Succeed' Trial of Oral Deforolimus in
Patients with Metastatic Sarcomas
Marks International Collaboration in Soft-Tissue and Bone Sarcoma
Clinical Trial
Will Evaluate Endpoint of Progression-Free Survival in Novel
Setting
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 24, 2007--ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced initiation of its
global Phase 3 clinical trial of oral deforolimus in patients with
metastatic soft-tissue and bone sarcomas. This pivotal trial will
assess progression-free survival (PFS) as the primary endpoint and
overall survival as a secondary endpoint in patients with metastatic
sarcomas following a favorable response to chemotherapy.
"The SUCCEED trial - one of the largest studies of patients with
soft-tissue and bone sarcomas ever conducted - represents an expansive
international collaboration of sarcoma experts to test a hypothesis
that could shift the paradigm of how such patients are treated," said
George D. Demetri, M.D., Director, the Ludwig Center at Dana-Farber
Cancer Institute and Associate Professor of Medicine, Harvard Medical
School, Boston. "In particular, this trial is designed to study a new
treatment option vs. the current standard of "watchful waiting" for
disease progression. Thus, the trial will provide a unique opportunity
to evaluate whether more active management of the disease prolongs
progression-free survival over the traditional clinical approach."
The SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the
Efficacy of Deforolimus) trial is a randomized, double-blind,
placebo-controlled Phase 3 study of oral deforolimus in metastatic
sarcoma patients who have achieved a favorable response to
chemotherapy. Continued treatment with traditional chemotherapeutic
drugs has not been established to provide additional clinical benefit
after such a response. Thus, absent new alternatives, physicians
generally would either continue potentially toxic chemotherapy until
the side effects become unacceptable or, more commonly, monitor
patients carefully for disease progression (tumor growth) prior to
initiating another line of chemotherapy. Therefore, the placebo arm
represents a current standard of care for patients in this clinical
setting.
This trial is designed to evaluate approximately 650 patients who
will be randomized (1:1) to oral deforolimus or placebo at
approximately 125 sites. The trial is 90% powered to detect a 33%
increase in median PFS (corresponding to a hazard ratio of 0.75)
comparing the deforolimus arm with the placebo arm. Two interim
efficacy analyses are included. Complete patient enrollment and the
second interim analysis are expected to take place within
approximately two years of the first patient being enrolled.
"The start of the SUCCEED trial signals an important advance in
our comprehensive global development of deforolimus in oncology," said
Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
"Deforolimus is a promising targeted oral treatment, and we look
forward to obtaining further confirmation of its efficacy and safety
in patients with metastatic sarcomas from this trial. In addition, we
are looking forward to launching multiple additional clinical trials
with our partner Merck to assess the clinical benefit of oral
deforolimus in a broad range of other cancers - both as a single agent
and in combination with other targeted and chemotherapeutic agents."
For more information about the SUCCEED trial, patients and
physicians should visit the trial website at
http://www.succeedtrial.com or, after September 27, 2007, contact the
U.S. toll-free number 1-877-SUCCEED (1-877-782-2333) or the
international number 1-617-621-2302.
ARIAD and Merck & Co., Inc. have a global collaboration to jointly
develop and commercialize deforolimus for oncology. Merck will pay
ARIAD a $13.5 million milestone upon dosing of the first patient in
the Phase 3 trial.
ARIAD recently reached agreement on a Special Protocol Assessment
(SPA) with the U.S. Food and Drug Administration for the trial. The
European Medicines Agency has provided protocol advice consistent with
that of the FDA regarding the trial design as part of its Protocol
Assistance program.
About Sarcoma
Sarcomas are a group of aggressive cancers of connective tissue of
the body for which there are currently limited treatment options.
Sarcomas can arise anywhere in the body and are divided into two main
groups - bone tumors and soft-tissue sarcomas. They are further
subdivided based on the type of cell or tissue which the tumor
resembles. There are approximately 12,000 new cases of sarcoma
diagnosed each year in the U.S. and approximately 100,000 sarcoma
patients overall in the U.S. More information about sarcomas is
available at http://www.curesarcoma.org and at
http://www.sarcoma.net/facts/htm.
About Deforolimus
ARIAD's lead product candidate, deforolimus, is a novel
small-molecule inhibitor of the protein mTOR, a "master switch" in
cancer cells. Blocking mTOR creates a starvation-like effect in cancer
cells by interfering with cell growth, division, metabolism, and
angiogenesis. Multiple Phase 1 and 2 clinical trials of deforolimus in
solid tumors and hematologic cancers have completed patient
enrollment. The global Phase 3 SUCCEED trial of oral deforolimus in
metastatic soft-tissue and bone sarcomas is based on a Special
Protocol Assessment agreed upon by the U.S. Food and Drug
Administration. ARIAD has a global partnership with Merck & Co., Inc.
to develop and commercialize deforolimus in cancer. ARIAD is also
collaborating with Medinol Ltd. to develop stents and other medical
devices that deliver deforolimus to prevent reblockage at sites of
vascular injury following stent-assisted angioplasty.
About ARIAD
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat cancer by regulating cell signaling with small
molecules. ARIAD is developing a comprehensive approach to patients
with cancer that addresses the greatest medical need - aggressive and
advanced-stage cancers for which current treatments are inadequate.
ARIAD has a global partnership with Merck & Co., Inc. to develop and
commercialize deforolimus, ARIAD's lead cancer product candidate.
Medinol Ltd. also is developing stents and other medical devices that
deliver deforolimus to prevent reblockage at sites of vascular injury
following stent-assisted angioplasty. ARIAD has an exclusive license
to pioneering technology and patents related to certain NF-(kappa)B
treatment methods, and the discovery and development of drugs to
regulate NF-(kappa)B cell-signaling activity, which may be useful in
treating certain diseases. Additional information about ARIAD can be
found on the web at http://www.ariad.com.
This press release contains "forward-looking statements,"
including statements related to the design, conduct and timing of the
Phase 3 clinical trial of deforolimus in metastatic sarcoma.
Forward-looking statements are based on management's expectations and
are subject to certain factors, risks and uncertainties that may cause
actual results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements. These
risks and uncertainties include, but are not limited to, the costs
associated with our research, development, manufacturing and other
activities, the conduct and results of pre-clinical and clinical
studies of our product candidates, difficulties or delays in obtaining
regulatory approvals to market products resulting from our development
efforts, our reliance on partners, including Medinol and Merck, and
other key parties for the successful development, manufacturing and
commercialization of products, the adequacy of our capital resources
and the availability of additional funding, patent protection and
third-party intellectual property claims relating to our and any
partner's product candidates, the timing, scope, cost and outcome of
legal and patent office proceedings concerning our NF-(kappa)B patent
portfolio, the potential acquisition of or other strategic transaction
regarding the minority stockholders' interests in our 80%-owned
subsidiary, ARIAD Gene Therapeutics, Inc., future capital needs, key
employees, markets, economic conditions, prices, reimbursement rates,
competition and other factors detailed in the Company's public filings
with the U.S. Securities and Exchange Commission. The information
contained in this document is believed to be current as of the date of
original issue. The Company does not intend to update any of the
forward-looking statements after the date of this document to conform
these statements to actual results or to changes in the Company's
expectations, except as required by law.
CONTACT: ARIAD Pharmaceuticals, Inc.
Edward M. Fitzgerald, 617-621-2345
or
Sondra Newman, 617-877-5687