VANCOUVER, March 16 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX), announced results from an analysis of one-year subset data from the HORIZONS AMI trial assessing the impact of diabetes on clinical and angiographic outcomes in heart attack patients treated with the TAXUS(R) Express(2)(TM) Paclitaxel-Eluting Stent System or the Express(R) bare-metal stent. The results demonstrated that the TAXUS(R) Express(R) Stent significantly reduced ischemia-driven target lesion revascularization (TLR) at one year and binary in-stent restenosis at 13 months in diabetic patients experiencing an acute myocardial infarction (AMI, or heart attack) compared to an otherwise identical bare-metal control stent. Analysis of the data was presented today at the American College of Cardiology Annual Scientific Sessions by Bernhard Witzenbichler, M.D., Department of Cardiology and Pneumology, Universitatsmedizin Berlin.
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Boston Scientific also announced it has submitted an application to the U.S. Food and Drug Administration (FDA) requesting expansion of the indications for use of the TAXUS Express and TAXUS(R) Liberte(R) Stents to include patients experiencing AMI.
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"Results from the HORIZONS AMI trial showed impressive efficacy benefits at one year for diabetic AMI patients treated with the TAXUS Express Stent when compared to bare-metal stents," said Keith Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific. "The data also showed comparable safety outcomes for TAXUS Express and bare-metal stents in diabetic patients. This study provides important data to physicians regarding the use of drug-eluting stents in high-risk AMI patients, especially those with diabetes, during the early hours of a heart attack. We are proud to support this and other large clinical trials that provide the medical community data that can be used in combination with broader clinical judgment to develop optimal treatment strategies for challenging patient subsets."
HORIZONS AMI results demonstrated that the TAXUS Express Stent significantly reduced ischemia-driven TLR compared to the bare-metal control stent (BMS) in both diabetic patients (5.2% vs. 11.2%, p=0.03, a 54 percent reduction), and non-diabetic patients (4.3% vs. 6.8%, p=0.02, a 37 percent reduction). Binary in-stent restenosis at 13 months was also significantly reduced for diabetic patients treated with the TAXUS Express Stent compared to BMS (8.2% vs. 43.9%, p less than 0.0001, an 81 percent reduction). Additionally, mean angiographic late loss at 13 months was significantly reduced for diabetic patients treated with the TAXUS Express Stent compared to BMS (0.38 mm vs. 1.13 mm, p less than 0.0001, a 66 percent reduction).
The primary safety measure of major adverse cardiac events (MACE) at one year was comparable between diabetic patients treated with the TAXUS Express Stent and BMS (10.2% vs. 12.5%, p=0.18), which is consistent with one-year findings from the overall HORIZONS AMI patient population. Rates of death or repeat heart attack at one year were also comparable for diabetic patients between the two treatment groups (8.8% vs. 10.7%, p=0.56). Stent thrombosis rates using the Academic Research Coalition (ARC) definite/probable definition were statistically similar for diabetic patients treated with the TAXUS Express Stent and BMS (3.1% vs. 4.5%, p=0.49).
Heart attack patients are often treated with bare-metal stents and are a more complicated patient population with known increased risks for death and stent thrombosis. Additionally, diabetic patients generally have more long-term complications than interventional cardiology patients as a whole, and account for more than one-quarter of all coronary interventional procedures in the United States. The diabetic subset population in the HORIZONS AMI trial presented with more complex baseline characteristics than non-diabetic patients, including significantly higher measures of weight, hypertension, peripheral vascular disease, renal insufficiency, prior MI, prior percutaneous coronary intervention and prior coronary artery bypass graft surgery.
With 3,006 patients enrolled worldwide, HORIZONS AMI is the largest randomized trial to compare the use of drug-eluting stents to bare-metal stents in AMI patients.
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/A, as amended, and our quarterly reports for the first, second and third quarters of 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.
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About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company. 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.
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