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Angiotech';s corporate partner, Boston Scientific, reports two-year SYNTAX data showing comparable safety outcomes for complex

^{Published on 2009-09-02 12:34:18 - Market Wire}
 

 VANCOUVER and BARCELONA, Sept. 2 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that its corporate partner, Boston Scientific (NYSE: BSX), has reported two-year data from its SYNTAX clinical trial comparing percutaneous coronary intervention (PCI) using the Taxus(R) Express(R) Paclitaxel-Eluting Coronary Stent System to coronary artery bypass graft (CABG) surgery. The overall results demonstrated no statistically significant difference between PCI and CABG in the composite safety endpoint (all-cause death, stroke and myocardial infarction (MI)). Boston Scientific made the announcement at the annual European Society of Cardiology (ESC) Congress in Barcelona. "These results reinforce the one-year SYNTAX data and show impressive outcomes for PCI in patients with complex coronary anatomy, the majority of whom are normally treated with CABG surgery," said Keith D. Dawkins, M.D., Associate Chief Medical Officer of Boston Scientific. "Today's findings build on our prior data and provide additional support for PCI as a viable treatment option for many of these challenging patients." The patients in the SYNTAX trial - all of whom have left main and/or three-vessel coronary disease - are a unique study group in the PCI field. In the SYNTAX trial, mean stent use was 4.6 stents/patient, with one patient having 14 stents implanted. By contrast, the average number of stents implanted in a PCI patient in everyday practice is 1.5. In addition, the study included 33 percent of patients with (greater than)100 mm stented length, 71 percent with bi/trifurcations, 27 percent with chronic total occlusions and 39 percent with left main disease. The results showed comparable safety profiles for the two treatment groups at two years, with a combined rate of all-cause death, stroke and MI of 10.8 percent for PCI and 9.6 percent for CABG (p=0.44). The rate of stroke was 1.4 percent for PCI as compared to 2.8 percent for CABG (p=0.03), while MI was 5.9 percent for PCI and 3.3 percent for CABG (p=0.01). The rate of all-cause death was 6.2 percent for PCI and 4.9 percent for CABG (p=0.24). Overall MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate, including all-cause death, stroke, MI and repeat revascularization) was significantly higher for PCI (23.3 percent as compared to 16.4 percent for CABG, p=0.0002), driven largely by the anticipated higher rate of revascularization in the PCI group (17.4 percent as compared to 8.6 percent for CABG, p(less than)0.0001), with the difference narrowing in the second year of follow-up. Most patients requiring repeat revascularization in the PCI group were successfully treated with another PCI. The trial results were also analyzed based on the SYNTAX Score, which demonstrated no statistically significant difference in MACCE for patients in the lower two terciles - those with low lesion complexity (19.4 percent for PCI and 17.4 percent for CABG, p=0.63) and moderate lesion complexity (22.8 percent for PCI and 16.4 percent for CABG, p=0.06). For patients in the upper tercile - those with the most complex disease - there was a significant increase in MACCE for PCI patients as compared to CABG (28.2 percent as compared to 15.4 percent, p=0.001). The SYNTAX Score is a novel angiographic tool used to measure the complexity of coronary artery disease based on nine anatomic criteria, including lesion frequency, complexity and location. Higher SYNTAX Scores indicate patients with more complex disease and increased treatment challenges. A SYNTAX Score website, [ www.syntaxscore.com ], was launched in May and allows cardiologists and cardiac surgeons to characterize a patient's anatomical complexity, which can be used in combination with a physician's clinical judgment to help determine the best revascularization option. The SYNTAX Score and SYNTAX Score website were developed under the direction of the SYNTAX trial steering committee, chaired by Patrick Serruys, M.D., Ph.D and F.W. Mohr, M.D., Ph.D., and were made possible by support from Boston Scientific and Cardialysis BV. The safety and effectiveness of the TAXUS Express Stent System has 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 Private Securities Litigation Reform Act of 1995 and constitute "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 the remainder of 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 and development and 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 known 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 in the United States, Canada and the other 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; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; 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, to expand manufacturing and commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any 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 our 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 availability of capital to finance our activities; our ability to restructure and to service our debt obligations; and any other factors referenced in our other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission ("SEC"). 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 June 30, 2009 filed with the SEC on Form 10-Q. Given these uncertainties, assumptions and risk factors, investors 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. (C)2009 Angiotech Pharmaceuticals, Inc. All Rights Reserved. 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 (NASDAQ: ANPI, TSX: ANP), please visit our website at [ www.angiotech.com ].

For further information: Irma Gomez-Dib, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (212) 850-5761, [ irma.gomez-dib@fd.com ]; Sharrifah Al-Salem, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4414, [ sharrifah.alsalem@fdashtonpartners.com ]