VANCOUVER, July 16 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX) has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) Long Paclitaxel-Eluting Coronary Stent System, a next-generation drug-eluting stent (DES) designed for long lesions. At 38 mm, it is the longest available DES, providing doctors an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. It affords a more efficient treatment option for the estimated 8 to 10 percent(1) of patients with long lesions. Boston Scientific plans to launch the product in the U.S. next month. It received CE Mark approval in 2007.
"The TAXUS Liberte Long Stent offers physicians and patients distinct advantages compared to using two overlapping drug-eluting stents," said Mark Turco, M.D., FACC, FSCAI, Director of the Center for Cardiac Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. "In the ATLAS Long Lesion Trial, the 38 mm TAXUS Liberte Stent significantly reduced myocardial infarction when compared to the TAXUS(R) Express(R) Stent, making the TAXUS Liberte Long Stent an attractive option for interventional cardiologists faced with long, challenging lesions."
The TAXUS ATLAS Long Lesion Trial reported a significant 79 percent reduction in the rate of nine-month myocardial infarction for the TAXUS Liberte Long Stent as compared to the TAXUS Express Stent control (1.3% vs. 6.3%, p=0.026). At two years, the composite measure of cardiac death or myocardial infarction showed a significant 63 percent reduction for the TAXUS Liberte Long Stent compared to the TAXUS Express Stent (3.5% vs. 9.4%, p=0.0426). The rate of stent thrombosis at two years was zero percent for the TAXUS Liberte Long Stent and 0.8 percent for the TAXUS Express Stent(2).
"Today's approval of the TAXUS Liberte Long Stent, along with the approval of the TAXUS Liberte Atom(TM) Stent in May, demonstrates the strength and breadth of the paclitaxel platform," said Dr. William Hunter, President and CEO of Angiotech. "We are pleased with the progress that Boston Scientific continues to make with TAXUS stents."
Boston Scientific has the industry's widest range of coronary stent sizes. The TAXUS Liberte Stent Series is now available in 92 sizes, ranging from 2.25 mm to 4.0 mm in diameter and from 8 mm to 38 mm in length.
TAXUS Stents have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 35,000 patients enrolled in post-approval registries. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world's most frequently used stents.
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 (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
----------------------------- (1) Percentage estimates from April 2009 Millennium Research Group report and ARRIVE 1 and 2 registries. (2) In the TAXUS ALTAS Long Lesion Trial, the TAXUS Liberte Long (38mm) Stent met its primary endpoint of non-inferiority to the TAXUS Express control Stent in nine-month percent diameter stenosis (31.7% vs. 32.6%, p=0.71) and reported a 36 percent reduction in MACE (9.4% vs. 14.8%, p=0.16). Forward Looking Statements --------------------------
SOURCE Angiotech Pharmaceuticals, Inc.