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Last updated on April 20, 2014 at 21:20 EDT

Angiotech partner Cook Medical receives FDA approval for its Zilver PTX Paclitaxel-eluting peripheral stent

November 16, 2012

VANCOUVER, Nov. 16, 2012 /PRNewswire/ – Angiotech Pharmaceuticals, Inc.
(“Angiotech”) announced that its partner Cook Medical, Inc. (“Cook”)
received approval on November 15, 2012 from the U.S. Food and Drug
Administration (“FDA”) to market and sell the proprietary Zilver® PTX®
drug-eluting peripheral stent, adding the United States to the list of
over 50 markets, including the European Union and Japan, where Zilver
PTX is approved for sale. Zilver PTX is the first drug-eluting stent
indicated for use in peripheral artery disease approved by the FDA.

“We wish to offer our congratulations to Cook Medical on this important
milestone in the development and commercialization of Zilver PTX,” said
Thomas Bailey, President and CEO of Angiotech. “The use of paclitaxel
to treat restenosis is Angiotech’s founding technology platform, and we
are excited to see this technology further developed and commercialized
by Cook in a truly novel product for the treatment of peripheral
vascular disease.”

Cook’s Zilver PTX peripheral stent incorporates Angiotech’s proprietary
paclitaxel technology, which was first commercialized by Angiotech’s
partner Boston Scientific Corporation (“BSC”) in the TAXUS® stent
platform for the treatment of coronary artery disease. Paclitaxel
eluting stents have been shown in multiple clinical studies, in both
coronary and peripheral vascular disease, to reduce rates of repeat
blockages, or restenosis, following initial implantation of a stent in
diseased vessels.

Data from Cook’s pivotal clinical trial indicate that eight out of 10
patients treated with Zilver PTX still had open arteries (primary
patency) after one year, as compared to only three out of 10 patients
treated with balloon angioplasty alone. In addition, patients who
received a bare metal stent required more than twice as many
reintervention procedures to reopen the treated vessel as compared to
patients who received Zilver PTX.

Cook and BSC originally licensed Angiotech’s proprietary paclitaxel
technology in 1997. Angiotech receives royalties from Cook derived from
Cook’s sales of Zilver PTX.

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 in 2012 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 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; competition; technological changes that could impact our
existing products or our ability to develop and commercialize future
products; 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 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
successfully manufacture, market and sell our products; changes in our
business strategy or development plans; our ability to attract and
retain qualified personnel; our ability to successfully complete
pre-clinical and clinical development of our products; 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; the availability of capital to finance our
activities; our ability to service our debt obligations; and any other
factors referenced in our other filings with the SEC. For a more
thorough discussion of the risks associated with our business, see the
“Risk Factors” section in our quarterly report for the three and nine
months ended September 30, 2012 filed with the SEC on November 14, 2012
on Form 10Q.

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.

(©)2012 Angiotech Pharmaceuticals, Inc. All Rights Reserved.

About Angiotech

Angiotech develops, manufactures and markets medical device products and
technologies, primarily within the areas of interventional oncology,
wound closure and ophthalmology. Our strategy is to utilize our precision manufacturing capabilities and
our highly targeted sales and marketing capabilities to offer novel or
differentiated medical device products to patients, physicians and
other medical device manufacturers or distributors. For additional
information about Angiotech, please visit our website at www.angiotech.com.

SOURCE Angiotech Pharmaceuticals, Inc.


Source: PR Newswire