VANCOUVER, May 19 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc. today announced that its corporate partner, Boston Scientific Corporation has reported positive outcomes from a substudy of patients with left main coronary disease who were treated with the TAXUS(R) Express(2)(R) Paclitaxel-Eluting Coronary Stent System. SYNTAX-LE MANS is a substudy of the landmark SYNTAX trial, the first randomized, controlled clinical trial to compare percutaneous coronary intervention (PCI) using the TAXUS Stent to coronary artery bypass graft (CABG) surgery in patients with left main disease and/or significant narrowing of all three coronary arteries (three-vessel disease). The substudy data were presented by A. Pieter Kappetein, M.D., Ph.D., at the annual EuroPCR Scientific Program in Barcelona.
SYNTAX-LE MANS compares late angiographic and clinical outcomes in 263 patients with left main disease (149 treated with the TAXUS Stent and 114 treated with CABG). It is designed to assess 15-month patency (vessel openness) and the safety of stents and grafts in this high-risk population; it includes separate primary endpoints for each treatment arm. For PCI patients, the primary endpoint is the rate of long-term patency (defined here as (less than)50% stenosis) of the treated lesion sites. For CABG patients, the primary endpoint is the ratio of obstructed/occluded grafts (defined here as (greater than or equal to)50% stenosis) to total placed grafts. Results were presented separately for each group, and no formal statistical inferences between the two groups were made due to the different primary endpoints. Results were also broken out by left main lesion location, including distal and non-distal.
For those patients receiving a TAXUS Stent, the patency rate for the treated lesion was 92 percent. Restenosis was more common with distal lesions (90% patency) compared with non-distal lesions (98% patency). Reported in-stent late loss was low at 0.2 mm for non-distal lesions. The reported 15-month MACCE rate (all-cause death, stroke, myocardial infarction and revascularization) for the TAXUS Stent patients was 13 percent, driven primarily by a nine percent repeat revascularization rate.
For CABG patients, the overall obstruction/occlusion ratio at 15 months was 16 percent, with six percent of grafts obstructed in the range of (greater than or equal to)50% to (less than)100%, and 10 percent of grafts occluded 100%. On a per patient basis, the obstruction/occlusion ratio was 27 percent, with nine percent of patients having a graft obstructed in the (greater than or equal to)50% to (less than)100% range and 18 percent of patients having a graft occluded 100%. The reported MACCE rate for CABG patients at 15 months was nine percent.
"The data announced today from SYNTAX-LE MANS will offer important insights for doctors as they evaluate treatment options for challenging left main patients," said Keith Dawkins, M.D., Associate Chief Medical Officer of Boston Scientific. "We are encouraged by the high stent patency rate at 15 months, which increases our confidence in the application of PCI in this high-risk population. The results support previously announced outcomes with PCI and CABG in patients with left main disease."
The safety and effectiveness of the TAXUS Express(2) Stent System have not been established in patients with left main or three-vessel disease.
Forward Looking Statements --------------------------
Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimates," "continues," "anticipates," "intends," "expects" and similar expressions, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the "safe harbor" provisions of applicable securities legislation. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2009 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research, development, product and drug development. 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. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions, both nationally and in the regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products sold by our partners; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to conduct research and development and to expand manufacturing and commercialization activities or consummate acquisitions; and any other factors that may affect performance. In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this press release to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in business strategy or development plans; our failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; our ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; the ability to enter into, and to maintain, corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the continued availability of capital to finance our activities; and any other factors referenced in our other filings with the Securities and Exchange Commission ("SEC") and applicable Canadian regulatory authorities. For a more thorough discussion of the risks associated with our business, see the "Risk Factors" section in our annual report for the year ended December 31, 2008 filed with the SEC on Form 10-K, and our quarterly report for the three months ended March 31, 2009 filed with the SEC on Form 10-Q.
Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, we disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this press release to reflect future results, events or developments.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech , please visit our website at http://www.angiotech.com/.
Angiotech Pharmaceuticals, Inc.
CONTACT: DeDe Sheel, Investor Relations and Corporate Communications,
Angiotech Pharmaceuticals, Inc., (415) 293-4412,
dede.sheel@fdashtonpartners.com
