ARIAD Pharmaceuticals, Inc. 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 US, 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 US 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, MD, 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.”
Following completion of the administrative validation process for the MAA by the EMA, which is targeted for mid-August, the application will have been accepted, and the scientific review will begin. Acceptance of the MAA will trigger a $25 million milestone payment by Merck to ARIAD. Approval of ridaforolimus in the US will secure a $ 25 million milestone payment by Merck to ARIAD, and approval to sell ridaforolimus, including pricing approval, in the European Union will secure a $10 million milestone payment.
ARIAD's vision is to transform the lives of cancer patients with breakthrough medicines. Its mission is to discover, develop and commercialize small-molecule drugs to treat cancer in patients with the greatest and most urgent unmet medical need - aggressive cancers where current therapies are inadequate.