Interim Results Show Promise for Improving the Treatment of Blockages in
the Femoropopliteal Artery
VANCOUVER, June 11 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that its corporate partner, Cook Medical, has reported positive interim results from the registry arm of a clinical study measuring the effectiveness of its Zilver PTX drug-eluting peripheral stent in treating peripheral arterial disease (PAD). The results, which were reported by the trial investigators last week at the 2008 SVS Vascular Annual Meeting, revealed clinical improvement, excellent durability and fracture resistance, and high rates of event-free survival (EFS) and freedom from target lesion revascularization (TLR). In addition, the Zilver stent exhibited no safety concerns and results were better than expected for TASC class C and D lesions, occlusions, in-stent restenosis and lesions greater than seven centimetres (2.75 inches).
"Building on the success of our paclitaxel-eluting coronary stents, we are extremely pleased that Cook has met with early success in leveraging our technology with this first round of positive trial data for the Zilver PTX paclitaxel-eluting peripheral stent," said Dr. William Hunter, President and CEO of Angiotech. "We are hopeful that Cook will encounter similarly positive results throughout the duration of the Zilver PTX trial and we are excited about the potential benefits the Zilver PTX stent may provide patients suffering from PAD."
Interim data was compiled at six and 12 months using 435 patients and 200 patients, respectively. The corresponding EFS rates were 94 percent and 84 percent, and freedom from TLR was 96 percent and 88 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six months that was maintained through 12 months. Evaluation of stent x-rays is ongoing, and currently suggests stent fractures in approximately one percent of cases at six months and less than two percent of cases at 12 months. Follow-up to the registry arm of the study will continue through two years.
Under the terms of its 1997 License Agreement with Cook, Angiotech is entitled to receive royalty payments upon the commercial sale of paclitaxel-eluting peripheral vascular stent products, including the Zilver PTX.
The Zilver PTX is currently undergoing multiple clinical trials in the United States, Asia, Latin America, Canada and Europe to assess product safety and efficacy.
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," "estimate," "continue,"
"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 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 strategies or future
actions, our targets, expectations for our financial condition and the
results of, or outlook for, our operations, research 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 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 drug discovery and
clinical development processes; 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 commercialization activities or consummate
acquisitions or to service or repay debt obligations; the accuracy of our
estimations of the size of the market, and the potential market, for our
products in specific disease areas; sales numbers and future guidance
publicly provided by Boston Scientific Corporation regarding sales of their
paclitaxel-eluting coronary stent products; 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 report to differ materially from our
actual results. These operating risks include: our ability to attract and
retain qualified personnel; our ability to successfully complete
preclinical 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 ability of Boston Scientific
Corporation to successfully manufacture, market and sell their
paclitaxel-eluting coronary stent products; the continued availability of
capital to finance our activities; our ability to achieve the financial
benefits expected as a result of the acquisition of American Medical
Instruments Holdings, Inc.; and any other factors referenced in our annual
information form and other filings with the applicable Canadian securities
regulatory authorities or the Securities and Exchange Commission. Given
these uncertainties, assumptions and risk factors, readers are cautioned
not to place undue reliance on such forward-looking statements. 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.
Zilver(R) PTX(TM) are trademarks of Cook Medical.
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 http://www.angiotech.com.
CONTACT: Deirdre Neary, Manager, Investor Relations and Corporate Communications, Angiotech Pharmaceuticals, Inc., (604) 222-7056, firstname.lastname@example.org
|SOURCE Angiotech Pharmaceuticals, Inc.|
Copyright©2008 PR Newswire.
All rights reserved