Miami Lakes, Fla.–based Cordis Corporation, a unit of New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ), the world's largest maker of medical devices, develops and manufactures the sirolimus-eluting CYPHER stent. Sirolimus is an immunosuppressive drug that lowers the body's natural immunity in patients and has been shown to prevent cellular proliferation and reduce restenosis.  Sirolimus, marketed as Rapamune® by Wyeth

Pharmaceuticals, a division of Wyeth (NYSE: WYE), is exclusively licensed worldwide by Cordis for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting.  Although Cordis was the first medical device company that received FDA approval to sell drug-eluting stents in April 2003, Johnson & Johnson's CYPHER market share has been rapidly overtaken by Boston Scientific 's TAXUS. According to Mr. Tobin in an interview with Boston Globe, many physicians favor Taxus because they find it conforms better to the shape of some arteries and thus is easier to implant than CYPHER.

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Earlier this year, Indianapolis, Ind.-based Guidant Corporation (NYSE: GDT) entered into the U.S. drug eluting stent market by announcing that it had entered into an agreement with Cordis Corporation to co-promote Cordis’ CYPHER™ Sirolimus-eluting Coronary Stent. Guidant will also assist Cordis in the development of a CYPHER stent that utilizes Guidant’s MULTI-LINK VISION® Stent Delivery System. The latest Guidant's MULTI-LINK VISION Coronary Stent System includes the next generation cobalt chromium stent technology for treatment of coronary artery disease in patients with small vessels at risk of sudden closure. Small vessels are defined as those with diameters of 2.5 mm or less; approximately 20 percent of atherosclerotic lesions occur in such vessels. 

Analysts believe that Guidant’s own drug eluting stent program, which utilizes the immunosuppressant drug Everolimus, is not expected to be impacted by the agreement with Cordis. The company expects to launch its CHAMPION™ Everolimus Eluting Stent System in Europe in the first quarter of 2005 and in the U.S. in the first quarter of 2006, pending regulatory approvals.

New Entries - In the last two months, two major medical device manufacturers, Abbott Vascular Devices, a division of Abbott Park, IL-based Abbott Laboratories (NYSE: ABT) and Medtronic Vascular, a division of Minneapolis, MN-based Medtronic, Inc. (NYSE: MDT) announced the clinical trials to evaluate the safety and efficiency of their drug-eluting stents.

Abbott's drug-eluting stent, ZoMaxx™, employs a proprietary phosphorylcholine polymer (PC) coating, Pharmacoat™, licensed from Surrey, UK-based Biocompatibles Ltd. (LSE:BII), to control the drug release. The immunosuppressant ABT-578 drug which is developed by Abbott

Laboratories, is an investigational drug and is not yet approved by the FDA. The goal of this trial is to compare its stent to Boston Scientific's Taxus™ Express2™ drug-eluting stent with a primary endpoint of 9-month in-segment late loss (a measurement of the re-narrowing of the vessel). Enrollment is expected to continue through the first quarter of 2005. 

Similar to ZoMaxx™ stents, Medtronic's cobalt chromium ENDEAVOR IV stent utilizes Abbott's ABT-578 drug, and proprietary Pharmacoat™ coating from Biocompatibles Ltd. Medtronic is planning to conduct the ENDEAVOR IV trial at approximately 70 sites throughout the U.S., beginning with patient enrollment in October this year. The goal of this trial is to compare its stent to Boston Scientific's Taxus™ Express2™ drug-eluting stent with the primary endpoint of the trial to be Target Vessel Failure (TVF) at nine months with a secondary endpoint of Major Adverse Cardiac Events (MACE) at 30-days. 

According the Dow Jones NewsWire, Medtronic's management has said it expects to have a 20% market share worldwide in drug-eluting stents during fiscal 2008. We believe that both ZoMaxx™ and ENDEAVOR IV stents will have no immediate material impact on sales of Boston Scientific's Taxus™ Express2™ drug-eluting stent.

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