Angiotech Pharmaceuticals Incorporated: Boston Scientific Reports Final Findings From Its Taxus I Drug-Eluting Stent Clinical Trial.

Business Editors

VANCOUVER, B.C.--(BUSINESS WIRE)--Nov. 13, 2001

Angiotech Pharmaceuticals Incorporated (Nasdaq:ANPI) (TSE:ANP.) confirmed today that Boston Scientific Corporation reported final six-month findings from its TAXUS I clinical trial, including angiographic "edge effect" analysis and intravascular ultrasound (IVUS) follow-up results.

TAXUS I was designed to assess the safety of a slow-release dose formulation, paclitaxel-eluting coronary stent for the treatment of restenosis. Boston Scientific states that the new data bolster previously reported interim results of zero restenosis and zero thrombosis for the TAXUS I trial, announced on September 24, 2001. The company also provided updates on the progress of the TAXUS II and TAXUS III trials, as well as the status of its submission to the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) for its TAXUS IV trial. The results and updates were reported at the annual meeting of the American Heart Association in Anaheim, CA.

In Boston Scientific's findings, the angiographic analysis demonstrated the absence of any edge effect at the proximal and distal edges in both the paclitaxel-eluting and bare-stent control groups. This edge effect, often referred to as the "candy-wrapper effect," has been demonstrated in several brachytherapy trials and has been a concern of some investigators with respect to drug-eluting stents. Today's data from the company suggests there is no edge effect with this paclitaxel-eluting stent at six-month follow-up.

Boston Scientific also stated that the IVUS results showed significant improvements in neointimal volume, percent neointimal volume index, and minimum lumen area (MLA) for the paclitaxel-eluting stent. The angiographic data announced in September found zero restenosis in the group treated with paclitaxel-eluting stents, and no patient developed either early or late stent thrombosis, as reported by the company.

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

"The edge effect analysis and the IVUS results expand on the impressive results reported earlier, and they reduce the concern that an edge effect may be the price we pay for reducing in-stent restenosis," said Professor Eberhard Grube, M.D., Siegburg Heart Center, Siegburg, Germany. "This further reinforces Boston Scientific's extensive pre-clinical and diligent clinical approach to developing the paclitaxel-eluting stent. We are looking forward to future TAXUS trials and ultimately being able to offer this type of product to our patients."

"We were gratified to see that the final data mirrored the statistically significant improvements seen in the earlier data," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This additional data strengthens our belief that our technology represents a major contribution to the practice of interventional cardiology, and we look forward to making it available in other vascular beds as well."

TAXUS I is the first of four Boston Scientific-sponsored paclitaxel-eluting stent clinical trials to report six-month results. The TAXUS program is a series of studies designed to collect clinical information on Boston Scientific's proprietary paclitaxel-eluting stent technology for reducing coronary restenosis, the regrowth of vascular tissue within an artery after angioplasty and stenting. Paclitaxel, the active component of the popular chemotherapeutic agent Taxol(R), has demonstrated promising results in pre-clinical studies for reducing the processes leading to restenosis.

TAXUS I is a 61-patient, slow-release formulation, randomized, double-blind, multi-center safety trial. Boston Scientific reported that the trial included 31 patients in the experimental arm and 30 in the control arm, with de novo lesions up to 12 mm in length and approximately 3.0 mm in diameter. In May, TAXUS I reported on its primary endpoint, which was 30-day MACE (major adverse cardiac events). No MACE were reported. The trial was conducted at three centers in Germany.

FIRST HUMAN USE OF MODERATE-RELEASE DOSE FORMULATION

Boston Scientific also reported that the first patients have been enrolled in the moderate-release dose formulation cohort of its TAXUS II trial. This represents the first human use of the moderate-release formulation, the company stated, which will be used in the TAXUS IV trial in the United States. TAXUS II is a 532-patient, randomized, double-blind, multi-center, international study designed to assess safety and efficacy. In addition to monitoring clinical outcomes, Boston Scientific says the trial will assess the safety and efficacy of a slow-release formulation and a moderate-release formulation. The company also reported that enrollment has been completed in the study's slow-release formulation cohort. Earlier this month, the Data Safety Monitoring Board recommended that TAXUS II proceed to its moderate-release cohort.

"We are very pleased to have started enrollment in the moderate-release formulation cohort," said Jim Barry, Ph.D., Vice President of Corporate Research and Advanced Technology Development at Boston Scientific. "Given the excellent results achieved in TAXUS I with the slow-release formulation, we are optimistic about the flexibility the moderate-release formulation will provide in treating a broader - and in some cases more challenging - set of lesions."

TAXUS III is a 30-patient registry study examining the feasibility of the slow-release formulation for treatment of in-stent restenosis. Boston Scientific reported the completion of enrollment in July, and six-month follow-up results are expected by the company to be reported early next year.

Boston Scientific submitted an application to the FDA last month for an IDE for TAXUS IV, and it expects to begin enrolling patients before the end of the year. TAXUS IV is expected to enroll more than 1,600 patients and is a randomized, double-blind trial designed to study the safety and efficacy of a moderate-release formulation on both de novo lesions and in-stent restenosis.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

Angiotech Pharmaceuticals, Inc. is a Canadian pharmaceutical company dedicated to the development of medical device coatings and treatments for chronic inflammatory diseases through reformulation of the anticancer drug, paclitaxel. Several pharmaceutical therapies are in clinical development: systemic Micellar Paclitaxel for secondary progressive multiple sclerosis (Phase 2), rheumatoid arthritis (Phase 1) and severe psoriasis (Pilot Phase 2). The paclitaxel-coated coronary stent program is currently in international clinical safety and efficacy studies. Other medical device programs include paclitaxel-loaded surgical implants for the treatment of restenosis associated with peripheral vascular surgery and for the treatment of proliferative ocular conditions.

1 Taxol is a registered trademark of Bristol-Myers Squibb Co.

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