ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Medinol, Ltd. today announced the initiation of two registration trials of Medinol’s NIRsupreme TM Ridaforolimus-Eluting Coronary Stent System incorporating ARIAD’s mTOR inhibitor, ridaforolimus. The two NIRsupreme clinical trials are randomized, single-blind, global studies taking place in the United States, Europe, Israel and Canada and will enroll approximately 2,200 patients with coronary artery disease. ARIAD licensed ridaforolimus to Medinol for use in drug-eluting stents in 2005. Drug-eluting stents (DES) are now implanted in over 500,000 patients yearly in the United States.
The commencement of patient enrollment in Medinol’s clinical trials, along with the submission of an investigational device exemption with the U.S. Food and Drug Administration, triggers milestone payments to ARIAD of $3.75 million, with the potential for additional regulatory, clinical and sales milestones, as well as royalties on product sales.
The BIONICS trial aims to show that the NIRsupreme stent is comparable (non-inferior) to a comparator drug-eluting stent with the primary endpoint of coronary target lesion failure (a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization) at 12 months. This trial is expected to enroll approximately 1,900 patients.
The NIREUS trial aims to demonstrate angiographic non-inferiority of the NIRsupreme stent to a comparator stent and has a primary endpoint of late loss in lumen diameter within the stent determined by coronary angiography at six months. This trial is expected to enroll approximately 300 patients.“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,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. “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.”
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