Ariad, Merck Submit Ridaforolimus MAA

Ariad Pharmaceuticals and Merck have submitted a marketing authorization application (MAA) for ridaforolimus with the EMA. Merck is planning global submissions for ridaforolimus in Europe, the U.S., Canada, Asia-Pacific and Latin America and other key markets. Acceptance of the MAA will trigger a $25 million milestone payment to Ariad. The company will also receive a $25 million milestone payment upon approval in the U.S., while approval to sell ridaforolimus in the EU will secure a $10 million milestone payment.

If approved, 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 as a maintenance therapy, according to Ariad.

“We are delighted by the submission for regulatory review of ridaforolimus in the EU,” said 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 its review as a potential new treatment option for patients with metastatic soft-tissue and bone sarcomas.”