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Fast Track Status Granted to Protein Inhibitor mTOR, Potential Treatment for Soft Tissue and Bone Sarcomas

CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 20, 2005--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that its novel mTOR inhibitor, AP23573, has been designated a fast-track product by the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue and bone sarcomas. The FDA's decision was based, in part, on review of both Phase 1 and Phase 2 clinical trials of AP23573 conducted by ARIAD in refractory sarcoma patients and the recognition that soft tissue and bone sarcomas are serious and life-threatening conditions for which treatment options are limited or non-existent. The FDA's fast-track program is designed to facilitate the development and expedite the review of new drugs that have the potential to address unmet medical needs. Based on today's announcement, ARIAD will pursue treatment of soft tissue and bone sarcomas as the initial registration path for AP23573.

The benefits of the FDA's fast-track program include closer and more frequent interactions with the agency during clinical-trial planning and New Drug Application (NDA) filing and generally a higher likelihood of being granted accelerated approval on the basis of a surrogate measure of clinical benefit in cancer patients, such as progression-free survival.

"We believe that the FDA's fast-track designation for AP23573 is the Company's most important milestone to date," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Since there are no effective therapies currently available for advanced soft-tissue sarcomas or metastatic refractory sarcomas in general, the FDA decision represents a potential breakthrough for patients with an otherwise untreatable cancer."

Initial data from the ongoing Phase 2 study of AP23573 in patients with relapsed and/or refractory sarcoma will be presented at the American Society of Clinical Oncology annual meeting being held in Orlando, Florida, May 13 to 17, 2005.

About Sarcoma
Sarcomas are cancers of the connective tissue, including bones, muscles, fat, cartilage, and joints, not discriminating 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.sarcomafoundation.com and at http://www.sarcoma.net.

About AP23573
The 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 a fast-track product by the U.S. Food and Drug Administration for the treatment of soft tissue and bone sarcomas.

Source: Ariad Pharmaceuticals, Inc.

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