VANCOUVER, March 8 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. today announced that its corporate partner Boston Scientific Corporation (“BSC”) has submitted to the U.S. Food and Drug Administration (FDA) the final module of BSC’s Pre-Market Approval (PMA) application for its TAXUS(R) Liberte(TM) paclitaxel-eluting coronary stent system. The TAXUS Liberte system is BSC’s next-generation drug-eluting stent system. The third and final PMA module contains nine-month data from the ATLAS clinical trial, a global, multi-center, pivotal study designed to support FDA approval of the TAXUS Liberte system in the United States.
Pre-Market Approval is the FDA process of scientific and regulatory review to evaluate the safety and efficacy of Class III medical devices prior to approval to market a device in the United States.
BSC launched its TAXUS Liberte stent system in select international markets in January 2005 and received the CE Mark in Europe in September 2005. In April 2005, BSC received U.S. FDA approval for its Liberte(TM) bare-metal coronary stent system.
BSC will announce nine-month data from its pivotal ATLAS clinical trial at the EuroPCR conference in May.
BSC 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.
About Angiotech Pharmaceuticals
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty pharmaceutical company pioneering the combination of pharmaceutical compounds with medical devices and biomaterials to both create novel solutions for poorly addressed disease states and improve surgical outcomes. To find out more about Angiotech Pharmaceuticals, Inc. , please visit our website at www.angiotech.com.
Statements contained herein that are not based on historical or current fact, including without limitation statements containing the words “anticipates,” “believes,” “may,” “continue,” “estimate,” “expects,” and “will” and words of similar import, constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the following: general economic and business conditions, both nationally and in the regions in which the Company operates; technology changes; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; liability and other claims asserted against the Company; and other factors referenced in the Company’s filings with the United States Securities and Exchange Commission or the Canadian securities regulators. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company does not assume the obligation to update any forward-looking statements.
FOR ADDITIONAL INFORMATION: --------------------------- Analysts and Investors: Rui Avelar, Chief Medical Officer Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933 Media: Colleen Beauregard Waggener Edstrom Bioscience (503) 443-7863, Email: colleenb@wagged.com
Angiotech Pharmaceuticals, Inc.
CONTACT: Analysts and Investors: Rui Avelar, Chief Medical Officer,Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext 6933; Media: ColleenBeauregard, Waggener Edstrom Bioscience, (503) 443-7863, Email:colleenb@wagged.com