According to the American Heart Association’s Heart Disease and Stroke Statistics for 2007, an estimated 79.4 million (one in three) American adults were afflicted with one or more types of cardiovascular disease. The estimated direct and indirect cost of cardiovascular disease for the year 2007 exceeded $430 million.
Products expected to have the most profound impact on coronary artery and myocardial disorders include drug-eluting stents. The U.S. market for interventional cardiology devices is valued at approximately $5 billion, with drug-eluting stents representing the largest segment of the market.*
As an mTOR inhibitor, ridaforolimus has been shown to block the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and blockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. Recent clinical studies have found lower reblockage rates in patients treated with stents that deliver small-molecule drugs, such as sirolimus or paclitaxel, a cytotoxic agent, locally to the site of vascular injury. Such stents have become the standard-of-care for patients undergoing interventional procedures to open narrowed coronary arteries.
We entered into license agreements with Medinol, Ltd., a leading innovator in stent technology, in January 2005, and with ICON Medical Corp.,, an emerging medical device company, in October 2007, to develop and commercialize stents and other medical devices that deliver ridaforolimus to prevent restenosis, or reblockage, of injured vessels following interventions in which stents are used in conjunction with balloon angioplasty. We have retained the right to enter into one additional non-exclusive license agreement, in addition to the licenses granted to ICON and Medinol, to develop and commercialize medical devices delivering ridaforolimus for use in vascular disease.
* Source: U.S. Market for Interventional Cardiology Devices (Vancouver: iData Research Inc., 2007).
