Stent trial fails to meet endpoints

Mar 7 2005

Angiotech Pharmaceuticals has announced that results from the REALITY Trial, a head-to-head trial sponsored by Cordis Corporation, comparing the JNJ CYPHER® stent and the TAXUS® stent, were presented at the American College of Cardiology Annual Scientific Session. The trial failed to meet its primary endpoint.

Stent thrombosis is a severe complication of stenting and can result in heart attacks and death. Patients who received stents are typically prescribed anti-platelet therapy to reduce the risk of stent thrombosis.

Sponsored by Cordis Corporation, a Johnson & Johnson company, the REALITY Trial is a prospective, randomized study involving 1,386 patients at 90 hospitals centers in Europe, Latin America and Asia.

In the REALITY trial, patients were included if they had up to two de novo (new) lesions with a primary lesion of at least 15 mm in length in small vessels (2.25 to 3.0 mm in diameter).

The two study arms were well balanced in terms of standard patient characteristics including age, sex and prior heart attack. Patients were also well balanced in terms of number of diseased arteries and the location of the lesions. On average, patients receiving the CYPHER® Stent had 1.91 stents while those receiving Taxus had 1.94 stents.

Since its inception, the TAXUS stent has consistently shown phenomenal safety data in every FDA monitored study and independent registry to date and was furthered today by the remarkable safety and efficacy results in TAXUS V, a study that enrolled 1,156 patients.

Angiotech finds JNJ's efforts today to tout a biased study that was not blinded to the doctor placing the stent or lab analyzing the data failed to meet its primary endpoint, predictable and desperate. Looking for minor trends in a study that failed is fraught with problems and rarely yields anything meaningful. Attempts to insinuate safety issues with nonsignificant data are as incredulous as the claims that the CYPHER stent is as deliverable as the TAXUS stent. In addition, claims such as favorable angiographic trends ignore the obvious issue typically seen in CYPHER trials, the delayed dilatation of blood vessels, a potentially toxic effect. Finally, despite the fact that the trial was sponsored by the competition, the efficacy of TAXUS was excellent.

"Despite the fact that this trial was sponsored by the competition, it still failed to meet the primary endpoint," said William Hunter, MD, MSc, President and CEO of Angiotech. "Attempts like this are to be expected against a market leader that carries a platform which has delivered consistent outstanding safety and performance and is backed by an unparalleled mass of challenging studies. Good science asks a single, unambiguous question - in this case, "Is CYPHER superior to TAXUS?" and despite the obvious limitations of this study, the resounding answer was "No"."

Boston Scientific acquired worldwide exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and has co-exclusive rights to other vascular and non-vascular products.

Vancouver-based Angiotech Pharmaceuticals, Inc., a specialty pharmaceutical company focusing on drug-coated medical devices and biomaterials, is dedicated to enhancing the performance of medical devices and biomaterials through the innovative uses of pharmacotherapeutics. To find out more about Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.

http://www.jnj.com, http://www.angiotech.com and http://www.cordis.com/