Angiotech's corporate partner, Boston Scientific, announces FDA approval of TAXUS(R) Express(2)(TM) Atom(TM) Stent System, first
25 September 2008 - 9:21PM
PR Newswire (US)
VANCOUVER, Sept. 25 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. ("Angiotech")
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global specialty
pharmaceutical and medical device company, today reported that its
corporate partner, Boston Scientific Corporation (NYSE:BSX), has
received U.S. Food and Drug Administration (FDA) approval to market
its TAXUS(R) Express(2)(TM) Atom(TM) Paclitaxel-Eluting Coronary
Stent System. The TAXUS Express Atom Stent is a highly deliverable
drug-eluting stent (DES) specifically designed for treating small
coronary vessels. It is the only DES approved by the FDA for use in
vessels as small as 2.25 mm in diameter. BSC plans to launch the
product immediately. "The TAXUS Express Atom Stent will provide
better options for U.S. patients with coronary artery disease in
small vessels," said Gregg Stone, M.D., Chairman of the
Cardiovascular Research Foundation and Professor of Medicine at
Columbia University Medical Center, and Principal Investigator of
the TAXUS IV and V clinical trials. "This is a welcome addition to
the range of available drug-eluting stents, since patients with
small vessels who are currently treated with bare-metal stents
experience high rates of restenosis. In the TAXUS V clinical trial,
the TAXUS Express Atom Stent significantly reduced the chance of
restenosis and the need for repeat procedures compared to
bare-metal stents, in patients with small vessel disease." "We
congratulate Boston Scientific on further expanding the paclitaxel
DES portfolio to help interventional cardiologists address the
unmet needs of patients suffering from small vessel disease," said
Dr. William Hunter, President and CEO of Angiotech. "We believe
this approval reflects the progress Boston Scientific is making
towards resolving the issues outlined two years ago in the
Corporate Warning Letter," he added. Currently the leading
drug-eluting stents worldwide, TAXUS Stent Systems have been
evaluated by the industry's most extensive randomized, controlled
clinical trial program, as well as studied in more than 35,000
real-world patients enrolled in post-approval registries. To date,
approximately 4.6 million TAXUS Stents have been implanted
worldwide. Cautionary Statement Regarding Forward-Looking
Statements
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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," "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 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
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; 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 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 (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. BSC acquired
worldwide exclusive rights from Angiotech to use paclitaxel to coat
its coronary stent products and has co-exclusive rights to certain
peripheral vascular and non-vascular products. TAXUS(R)
Express(2)(TM) Atom(TM) are trademarks of Boston Scientific
Corporation. About Angiotech 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:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. DATASOURCE: Angiotech Pharmaceuticals,
Inc. CONTACT: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
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