Exhibit 99.1
ARIAD Receives Orphan Drug Designations for AP23573 in Europe for the
Treatment of Soft Tissue and Bone Sarcomas
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 15, 2005--ARIAD
Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that AP23573, its
novel mTOR inhibitor, has been designated an orphan drug by the
European Medicines Agency (EMEA) for the treatment of both soft-tissue
and bone sarcomas. The U.S. Food and Drug Administration (FDA) granted
orphan drug status for AP23573 for both indications earlier this year.
"We now have orphan drug designations for AP23573 in Europe and
the United States for the treatment of advanced sarcomas, reinforcing
our commitment to the global development of AP23573. We are actively
engaged in discussions with the FDA and EMEA concerning our
registration strategy and the design of our initial pivotal clinical
trial for AP23573 in advanced sarcomas and are working towards
initiation of this trial in 2006," said Harvey J. Berger, M.D.,
chairman and chief executive officer of ARIAD.
The EMEA regulation on orphan medicinal products is designed to
encourage companies to develop and market treatments for rare,
life-threatening medical conditions that affect fewer than five people
in every 10,000 in the European Union (EU). In addition to potential
ten-year EU market exclusivity following marketing approval, orphan
drug status provides opportunities for regulatory assistance, reduced
regulatory fees associated with applying for marketing approval, and
protocol assistance.
About AP23573
ARIAD's small-molecule drug, AP23573, starves cancer cells and
shrinks tumors by inhibiting the critical cell-signaling protein,
mTOR, which regulates the response of tumor cells to nutrients and
growth factors, and controls tumor blood supply and angiogenesis
through effects on Vascular Endothelial Growth Factor (VEGF) in tumor
and endothelial cells. AP23573 also blocks the proliferation and
migration of vascular smooth muscle cells, the primary cause of
narrowing and reblockage of injured arteries, and is an analog of
sirolimus, another mTOR inhibitor that has been approved for use in
drug-eluting stents. AP23573 is currently in Phase 1 and 2 clinical
trials in patients with solid tumors and hematologic cancers. AP23573
has been designated both as a fast-track product and an orphan drug by
the U.S. Food and Drug Administration for the treatment of soft-tissue
and bone sarcomas.
About Sarcoma
Sarcomas are cancers of the connective tissue, including bones,
muscles, fat, cartilage, and joints and do not discriminate by age,
gender or race. Sarcomas can arise anywhere in the body and are
divided into two main groups - bone tumors and soft tissue sarcomas.
They are further sub-classified based on the type of cell or tissue
from which the tumor developed. There are approximately 12,000 new
cases of sarcoma diagnosed each year in the United States and
approximately 100,000 sarcoma patients overall in the United States.
More information about sarcomas is available at
http://www.curesarcoma.org.
About ARIAD
ARIAD is engaged in the discovery and development of breakthrough
medicines to treat disease by regulating cell signaling with small
molecules. The Company 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. Medinol Ltd. also is developing stents and other medical
devices that deliver ARIAD's lead cancer product candidate 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.
Some of the matters discussed herein are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements are identified by the use of words
such as "anticipate," "estimate," "expect," "project," "intend,"
"plan," "believe," and other words and terms of similar meaning in
connection with any discussion of future operating or financial
performance. Such statements, including statements concerning the
potential benefits of orphan drug designation for AP23573, are based
on management's current 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 forward-looking statements. These
risks include, but are not limited to, risks and uncertainties
regarding the Company's ability to accurately estimate the timing and
actual research and development expenses and other costs associated
with the preclinical and clinical development and manufacture of our
product candidates, the adequacy of our capital resources and the
availability of additional funding, risks and uncertainties regarding
our or our collaborator's ability to manufacture our product
candidates on a commercial scale or to supply our product candidates
to collaborators, risks and uncertainties regarding our ability to
successfully enroll and conduct preclinical and clinical studies of
product candidates, including our product candidate to treat various
cancers described in this release and our collaborator's medical
device product candidate to treat vascular disease, risks and
uncertainties that clinical trial results at any phase of development
may be adverse or may not be predictive of future results or lead to
regulatory approval of any of our or any collaborator's product
candidates, risks and uncertainties of third-party intellectual
property claims relating to our and any collaborator's product
candidates, and risks and uncertainties relating to regulatory
oversight, the timing, scope, cost and outcome of legal proceedings,
including litigation concerning our NF-(kappa)B patent portfolio,
future capital needs, key employees, dependence on collaborators and
manufacturers, markets, economic conditions, products, services,
prices, reimbursement rates, competition and other risks detailed in
the Company's public filings with the Securities and Exchange
Commission, including ARIAD's Annual Report on Form 10-K, as amended,
for the fiscal year ended December 31, 2004. 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.
Ed Fitzgerald (Investors)
617-621-2345
or
Sheryl Seapy (Media)
Pure Communications
949-608-0841