Boston Scientific Receives FDA Approval for U.S. Clinical Trial of its Paclitaxel-Eluting Coronary Stent System.

Business Editors & Health/Medical Writers

VANCOUVER, British Columbia--(BUSINESS WIRE)--March 21, 2002

Angiotech Pharmaceuticals, Inc. (Nasdaq:ANPI) (TSE:ANP) was notified today by Boston Scientific Corporation ("BSC") that BSC has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin its TAXUS IV clinical trial.

The fourth trial in the TAXUS(TM) drug-eluting stent program, TAXUS IV is a pivotal study to collect data to support regulatory filings for U.S. product commercialization. The prospective, randomized, double-blind trial is designed to assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS stent system for the treatment of coronary restenosis. More than 1,000 patients are scheduled to be enrolled at 80 sites, stated Boston Scientific. The TAXUS IV trial will use the Express(TM) stent, a laser-cut, balloon-expandable stent developed exclusively by Boston Scientific.

"Stellar clinical results from TAXUS I demonstrating zero restenosis and zero thrombosis to date has been extremely encouraging and the initiation of large scale pivotal trials in the U.S. is an important next step," said William Hunter, MD, MSc, Chairman and CEO of Angiotech. "We are excited to see paclitaxel combined with the new Express(TM) platform and believe that the TAXUS series of clinical studies will produce the most comprehensive data in the widest range of patients of any drug-coated stent program."

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

The TAXUS program is a series of clinical studies designed to collect data on Boston Scientific's proprietary paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of scar tissue within an artery after angioplasty and stenting. Paclitaxel, the active component of the popular chemotherapeutic agent Taxol(TM), has demonstrated promising results in preclinical and clinical studies for reducing the processes leading to restenosis. The comprehensive TAXUS program positions Boston Scientific to launch paclitaxel-eluting stents in Europe this year and in the U.S. in 2003.

Boston Scientific also stated that the TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial completed enrollment of 537 patients in January, and the patients are now in the follow-up period. Preliminary safety data from TAXUS II presented this week at the American College of Cardiology annual meeting provided further support for the safety of paclitaxel-eluting stents. The TAXUS III trial studied the treatment of in-stent restenosis and also confirmed safety with no thrombosis. The study reported encouraging efficacy data.

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