Ariad's AP23573 for sarcomas named orphan drug by European regulator

New York, Nov. 15 - Ariad Pharmaceuticals, Inc. said its AP23573 for the treatment of soft-tissue and bone sarcomas has been given orphan drug status by the European Medicines Agency (EMEA).

The U.S. Food and Drug Administration designated AP23573 as an orphan drug earlier in the 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," said Harvey Berger, chairman and chief executive officer of Ariad, in a news release.

"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 toward initiation of this trial in 2006."

The European Medicines Agency designates orphan drugs 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. Following marketing approval, orphan drugs receive 10-year market exclusivity in the European Union and regulatory assistance, reduced regulatory fees and protocol assistance.

AP23573 is a small molecule drug intended to starve cancer cells and shrinks tumors by inhibiting the 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 in tumor and endothelial cells.

Ariad is a Cambridge, Mass., biotech company developing medicines to treat disease by regulating cell signaling with small molecules.

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