VANCOUVER, Sept. 10 /CNW/ - Angiotech Pharmaceuticals, Inc. ("Angiotech")
(NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device
company, today announced that its corporate partner, Cook Medical, has
completed enrollment in the first international clinical trial of a
drug-eluting stent designed to treat arterial blockages outside the coronary
arteries. The 420 patients enrolled in Cook's randomized trial of its Zilver
PTX Drug Eluting Peripheral Stent include peripheral arterial disease (PAD)
patients treated in Germany, the United States and Japan.
"We would like to congratulate our partner Cook on completing enrollment
in this pioneering clinical program and for completing their CE Mark
submission in Europe," said Dr. Bill Hunter, President and CEO of Angiotech.
"The completion of this stage of the program demonstrates the continued
strength and breadth of our paclitaxel franchise, and brings us closer to
offering the same drug-eluting stent technology to patients with peripheral
artery disease that has benefited millions of coronary artery disease patients
In many cases, PAD patients who have been treated with balloon
angioplasty and stenting experience restenosis, or renarrowing of the
arteries, over time and must undergo more invasive treatment such as bypass
surgery to restore blood flow to key arteries. The Zilver PTX trial
(www.zilverptxtrial.com) was designed to determine whether the combination of
Cook's Zilver stent and the drug paclitaxel will keep peripheral arteries,
specifically the superficial femoral artery (SFA), open over time.
Cook already has enrolled 780 patients in the European Union, Canada, and
Korea in a clinical registry to evaluate the safety of the Zilver PTX device.
Those data have been used for a submission in Europe for CE Mark approval to
market the device there, with additional regulatory submissions pending in
additional markets. In addition, Zilver PTX stent already has regulatory
approval for commercial use in New Zealand, Hong Kong and Singapore, where it
has been used to treat patients suffering from PAD.
Cook licenses the rights to use paclitaxel with peripheral stents and
other non-coronary medical devices from Angiotech. 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.
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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,"
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Forward-looking statements may involve, but are not limited to, comments with
respect to our objectives and priorities for the second half of 2008 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 and product and drug development. Such forward-looking
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that may cause the actual results, events or developments to be materially
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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; and the
requirement for substantial funding to conduct research and development and to
expand manufacturing and commercialization activities or consummate
acquisitions. 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 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
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availability of capital to finance our activities; and any other factors
referenced in our other filings with the Securities and Exchange Commission
(the "SEC"). 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.
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:
For further information: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,