Date: Jan 14, 2014 Author: Don Seiffert Source: bizjournals (
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Don Seiffert
Boston Business Journal
It's been almost two years since Ariad Pharmaceuticals has talked about its investigational drug called ridaforolimus, but today it announced a revival of interest in the failed cancer drug.
The Cambridge biotech, which has been battered on the stock market in recent months due to safety issues related to its leukemia drug, Iclusig, said that an Israeli stent-maker, Medinol Ltd., has begun two trials of a stent which will use ridaforolimus to help prevent narrowing of arteries. Medinol licensed the drug from Ariad in a non-exclusive agreement almost nine years ago, and is paying Ariad (Nasdaq: ARIA) a $3.8 million milestone for beginning the clinical trial. Ariad could also earn additional milestones of up to $31 million, as well as global royalties.
Ridaforolimus was rejected by the U.S. Food and Drug Administration after an advisory panel voted against it in March 2012. The drug, a small-molecule inhibitor of a protein called mTOR, was going to be a potential treatment for soft-tissue and bone sarcomas (cancers of connective tissues) to be marketed by Ariad's partner, Merck & Co. under the name, Taltorvic. But the FDA panel judged that while the drug lengthened the time that patients survived without the cancer getting worse, those benefits were outweighed by risks of lowered blood platelets, inflammation in the mouth, anemia and hyperglycemia. The drug is still under license to Merck for its uses in oncology.
According to Ariad, besides being an inhibitor of a protein that regulates cell proliferation and survival, ridaforolimus also blocks the proliferation of vascular smooth muscle cells, which cause narrowing of injured arteries. The potential drug is similar to another mTOR inhibitor called sirolimus, which has been approved for use on drug-eluting stents.
The two clinical trials announced today by Medinol are randomized, single-blind studies of its stent, NIRsupreme, with sites in the U.S., Europe, Israel and Canada, and will enroll about 2,200 patients with coronary artery disease. Ariad will be responsible for supplying ridaforolimus to Medinol, and Medinol is responsible for the development and commercialization of the medical devices delivering ridaforolimus.
"We are pleased to have one of the most innovative and successful medical device companies advance the development and potential commercialization of drug-delivery stents incorporating ridaforolimus," Timothy Clackson, chief scientific officer at Ariad, said in a statement. "We believe that Medinol has developed a unique elastomeric formulation and stent platform, and we are delighted by the value created through this successful long-term collaboration with a true innovator."
Ariad was recently given the green light from the FDA to start selling Iclusig again in the U.S. after it was pulled from shelves in November due to higher-than-expected blood clotting. Since the problems with Iclusig were first made public, the company has laid off 160 employees and its stock has fallen 64 percent. On Monday, the company said that it now plans to make North Carolina-based Biologics Inc., an oncology services company, the sole specialty pharmacy provider of Iclusig. Ariad said the move was made to "to ensure a high-touch care model for patients on Iclusig" when the drug is made available again this month.
