Merck and ARIAD Announce European Medicines Agency Accepts Marketing Authorization Application for Ridaforolimus

Merck MRK and ARIAD Pharmaceuticals, Inc., ARIA, today announced that the European Medicines Agency has completed its administrative validation process for the regulatory application for ridaforolimus, an investigational oral mTOR inhibitor developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. The completion of the marketing authorization application validation process and acceptance for review now leads to the formal scientific review process by the EMA's Committee for Medicinal Products for Human Use. In addition to the EMA filing, Merck recently submitted a new drug application for ridaforolimus to the U.S. Food and Drug Administration. Within the next 60 days, the FDA will determine whether it will accept Merck's application as submitted. As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology. ARIAD intends to co-promote ridaforolimus in the United States.