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Drugs in R&D
Publication Date
DOI: 10.2165/11586010-000000000-00000
  • Adis R&D Profile
  • Biology
  • Medicine


1. Introduction Merck & Co. are developing ridaforolimus, an analog of sirolimus and a small molecule inhibitor of the mammalian target of rapamycin (mTOR), for the treatment of cancer. mTOR is a protein kinase that controls cell growth by regulating many cellular processes, including protein synthesis and autophagy. Compared with other mTOR inhibitors, ridaforolimus is not a prodrug and has shown in vivo stability. Both intravenous and oral formulations of the compound are being tested in clinical trials for the treatment of various solid tumors and hematologic malignancies. The initial indication is soft-tissue and bone sarcomas. ARIAD Pharmaceuticals, the compound’s originator, considered developing ridaforolimus for use in drug-eluting stents to prevent restenosis, in conjunction with balloon angioplasty. 1.1 Company Agreements In May 2010, ARIAD and Merck restructured their July 2007 collaboration agreement for ridaforolimus, so that Merck has the exclusive license to develop, manufacture, and commercialize the compound in oncology. Merck will assume responsibility and costs for all ridaforolimus activities, including clinical trials and regulatory filings. Merck will make an upfront cash payment of $US50 million to ARIAD and will reimburse ARIAD for its ridaforolimus expenses incurred since 1 January 2010, estimated at approximately $US19 million. The transfer of all ridaforolimus activities to Merck is expected to take 6 months, and Merck will reimburse ARIAD for all its ridaforolimus costs incurred until the transfer is completed. ARIAD will be eligible to receive up to $US514 million in regulatory and sales milestones, based on successful commercialization in multiple indications. This includes $US65 million in milestones associated with the potential sarcoma indication ($US25 million for acceptance of a new drug application [NDA] by the US FDA, $US25 million for US registration, $US10 million for European registration and $US5 million for Japanese registrat

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