Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine …

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--

Merck (MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for ridaforolimus. Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.

The complete response letter states that FDA cannot approve the application in its present form, and that additional clinical trial(s) would need to be conducted to further assess safety and efficacy. Merck also is in ongoing discussions with health authorities in Europeandother countries as part of their application procedures for ridaforolimus for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. Additionally, Merck is studying ridaforolimus in combination with other mechanisms in several tumor types.

Merck remains confident in the potential of ridaforolimus, said Eric Rubin, M.D., vice president, Clinical Research Oncology, Merck. We will continue to work closely with the FDA to define potential paths forward for this investigational therapy.

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.

As part of an exclusive license agreement with ARIAD Pharmaceuticals, Inc (ARIA), Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.

About Merck

Todays Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visitwww.merck.comand connect with us on Twitter, Facebook and YouTube.

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Merck Receives Complete Response Letter from U.S. Food and Drug Administration for Investigational Medicine ...