ANGIOTECH ANNOUNCES STRONG OUTCOMES IN DIABETIC PATIENTS TREATED WITH BOSTON SCIENTIFIC CORPORATION'S PLATINUM CHROMIUM TAXUS(R) ELEMENT(TM) STENT SYSTEM
VANCOUVER, Sept. 22 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX), has released results from an analysis of 1,166 patients from its PERSEUS clinical program comparing the performance of the TAXUS(R) Element(TM) Paclitaxel-Eluting Coronary Stent System in diabetic versus non-diabetic patients. Results demonstrated that despite the known increased risk of restenosis for diabetics versus non-diabetics in patients undergoing coronary revascularization, the TAXUS Element Stent had comparable levels of target lesion revascularization (TLR) and late loss in both diabetic and non-diabetic patients. Analysis of the data was presented by Louis A. Cannon, M.D., of the Cardiac and Vascular Research Center of Northern Michigan in Petoskey, Michigan, and Co-Principal Investigator of the PERSEUS clinical program, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C.
"The PERSEUS diabetic subset data showed that the TAXUS Element Stent mitigated the impact of diabetes as a risk factor for restenosis following stenting procedures in the patients studied," said Dr. Cannon. "At one year, no significant differences in measures of stent efficacy were observed between the two patient groups. Diabetic status was not a predictor of re-intervention in patients treated with the TAXUS Element Stent."
The PERSEUS diabetic analysis included clinical outcomes at one year among 314 diabetic patients and 852 non-diabetic patients treated with the TAXUS Element Stent from the PERSEUS Workhorse and Small Vessel clinical trials. Due to significant disparity in baseline characteristics between diabetic and non-diabetic patients, propensity score analysis was used to allow for adjustment of baseline differences (other than the presence of diabetes) between the two groups.
Results showed that the TAXUS Element Stent maintained comparable rates of TLR at one year, whether adjusted or unadjusted, in the diabetic and non-diabetic patient populations (5.5 percent vs. 4.1 percent, p=0.43, adjusted). The adjusted and unadjusted rates of target lesion failure (TLF) at one year (defined as ischemia-driven TLR, or MI/cardiac death related to the target vessel) were also similar between the patient groups (7.5 percent vs. 5.4 percent, p=0.31, adjusted). Adjusted one-year rates of MACE, cardiac death, MI and ARC(1) definite/probable stent thrombosis showed no differences between the two populations (p-values of 0.14, 0.12, 0.38, and 0.77, respectively).
Nine-month adjusted angiographic outcomes showed similar in-segment late loss in diabetics and non-diabetics (0.23 mm vs. 0.19 mm, p=0.52). Rates of late loss for the TAXUS Element Stent were numerically lower than rates in prior studies for the TAXUS Express(R) and TAXUS Liberté(R) Stents(2).
"The PERSEUS diabetic analysis reinforces the historically consistent performance of paclitaxel in diabetic patients compared to non-diabetic patients," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and Vascular Group. "The paclitaxel-based TAXUS Element Stent has a unique mechanism of action that helps inhibit restenosis across a wide variety of patients with coronary artery disease."
The TAXUS Element Stent leverages the performance advantages of the Element platform with a decade of clinical success from the TAXUS program. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents(3).
"We are pleased to see the strong performance of the TAXUS Element Stent in both the overall population of the PERSEUS trial and the diabetic patient subset," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "As the worldwide prevalence of diabetes continues to increase dramatically, these findings are very encouraging for physicians and their patients."
Diabetes is generally associated with an increased risk of cardiovascular events and patients with diabetes are more likely than non-diabetic patients to require repeat procedures due to a higher incidence of restenosis following angioplasty and stenting.
In March, Boston Scientific announced one-year results from its PERSEUS clinical program demonstrating positive safety and efficacy outcomes for the TAXUS Element Stent System compared to prior-generation Boston Scientific stents in more than 1,486 patients in two parallel trials at 90 centers worldwide.
The TAXUS Element Paclitaxel-Eluting Stent System received CE Mark approval in May, which included a specific indication for the treatment of diabetic patients. Boston Scientific expects U.S. Food and Drug Administration approval for the TAXUS Element Stent System(4) in mid 2011. In Japan, Boston Scientific expects approval for the TAXUS Element Stent System in late 2011 or early 2012.
In the U.S., the TAXUS Element (ION) Stent is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
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 2010 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 legislation and regulations and changes in, or the failure to comply with, governmental legislation and 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, 2009 filed with the SEC on Form 10-K, as amended, and our quarterly report for the second quarter of 2010 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)2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
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.
About Boston Scientific Corporation
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
--------------------- (1) Academic Research Consortium (2) The TAXUS Express and TAXUS Liberté Stent Systems are not specifically indicated for diabetic patients in the U.S. (3) Based on bench testing. Data on file with Boston Scientific. (4) The TAXUS Element Stent System will be commercialized as the ION(TM) Paclitaxel-Eluting Platinum Chromium Coronary Stent System in the U.S.
SOURCE Angiotech Pharmaceuticals, Inc.
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