Update on FDA Advisory Committee vote on investigational medicine Ridaforolimus

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), announced today that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of the investigational agent ridaforolimus as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.

The ODAC panel’s recommendation will be considered by the FDA when making its decision regarding the New Drug Application (NDA) for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas. The FDA is not bound by the Committee’s guidance, but takes its advice into account.

“Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options,” said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. “We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application.”

Sarcomas are a group of cancers of connective tissue of the body for which there are currently limited treatment options. Sarcomas can arise anywhere in the body and are divided into two main groups – bone tumors and soft-tissue sarcomas.

Ridaforolimus is an investigational small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN, known to be important to malignancy.

Merck and ARIAD previously announced that the FDA has accepted for filing and review the New Drug Application (NDA) for ridaforolimus. 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. The trade name for ridaforolimus in the United States is TALTORVIC®.