Angiotech Pharmaceuticals, Inc.: Boston Scientific To Provide Additional Information To FDA In Support Of Its TAXUS IV IDE Application.Business Editors VANCOUVER, B.C.--(BUSINESS WIRE)--Dec. 7, 2001 Angiotech Pharmaceuticals (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ANPI ANPI Angiotech Pharmaceuticals Inc. (Vancouver, BC, Canada) ANPI Associazione Nazionale Partigiani d'Italia (Italian: National Association of Partisans) ) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :ANP ANP atrial natriuretic peptide. ANP atrial natriuretic peptide. ANP Atrial natriuretic peptide, see there .) was notified today by Boston Scientific Corporation ("BSC (Binary Synchronous Communications) See bisync. ") that BSC will provide additional information requested by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in support of BSC's application for an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) for the TAXUS IV clinical trial, the fourth in a series of studies designed to collect clinical information on BSC's proprietary paclitaxel-eluting stent technology for reducing coronary restenosis. The TAXUS IV IDE application was submitted by BSC on October 25th, and earlier this week BSC met with the FDA to discuss questions related to the application and a request for additional information. BSC will provide the FDA with the information this month. "While we don't want to speculate on when FDA might approve the IDE, we are confident that we can address their questions, and we look forward to initiating this important trial," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We're enthusiastic about bringing the TAXUS program to the United States and building on the success it has enjoyed in Europe." In September, BSC reported zero restenosis and zero thrombosis for their TAXUS I trial. BSC also completed enrollment of its TAXUS II slow-release cohort in October, and the moderate-release cohort is expected to be fully enrolled next month. BSC also states that six-month follow-up data on each cohort is expected in mid-2002. TAXUS III completed enrollment in July, and six-month data will be presented at the March meeting of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. . BSC has acquired worldwide co-exclusive rights from Angiotech to use paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); to coat its coronary stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent products and other vascular and non-vascular products. 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 (PAXCEED(TM)) 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. 1 PAXCEED is a trademark of Angiotech Pharmaceuticals, Inc. Statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes", "may", "will", "estimate", "continue", "anticipates", "intends", "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments. |
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