Merck submits ridaforolimus MAA with EMA for treatment of metastatic soft-tissue, bone sarcomas

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that its ridaforolimus partner, Merck, has submitted a marketing authorization application (MAA) for ridaforolimus with the European Medicines Agency (EMA). The submission occurred on July 29, 2011 and marks the start of Merck's global submission strategy for ridaforolimus that includes Europe, the U.S., Canada, Asia-Pacific and Latin America and other key markets around the world.

ARIAD expects Merck to submit a new drug application (NDA) in the U.S. shortly. If approved, ARIAD believes that oral ridaforolimus, an investigational mTOR inhibitor, would be the first molecularly targeted drug for the treatment of patients with metastatic sarcomas and the first sarcoma drug to be approved for use in the maintenance setting.

"We are delighted by the submission for regulatory review of ridaforolimus in the European Union," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We look forward to the submission of additional filings on ridaforolimus and to the review of ridaforolimus as a potential new treatment option for patients with metastatic soft-tissue and bone sarcomas."