VANCOUVER, Sept. 22 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that its
corporate partner, Boston Scientific Corporation (NYSE: BSX), has
released comprehensive data from the TAXUS ATLAS clinical program,
a series of global, prospective, single-arm trials evaluating the
TAXUS(R) Liberté(R) Paclitaxel-Eluting Stent System in a variety of
lesions and patient groups. Five-year results from the TAXUS ATLAS
trial and four-year results from the TAXUS ATLAS Small Vessel and
Long Lesion trials continue to show significant advantages for the
thin-strut TAXUS Liberté Stent when compared to the
first-generation TAXUS(R) Express(R) Stent. Analysis of the data
was presented by the Co-Principal Investigators of the TAXUS ATLAS
trials, Mark A. Turco, M.D.,
Director of the Center for Cardiac and Vascular Research,
Washington Adventist Hospital, and John A.
Ormiston, M.D., Mercy Angiography Unit, Mercy Hospital,
Auckland, New Zealand, at the
Cardiovascular Research Foundation's annual Transcatheter
Cardiovascular Therapeutics scientific symposium in Washington, D.C.
"The TAXUS ATLAS trials continue to reinforce the long-term
safety and efficacy of the TAXUS Liberté Stent in a variety of
complex lesions," said Dr. Turco. "The data showed sustained
positive outcomes in workhorse lesions, significantly reduced rates
of re-intervention in small vessels and important safety
differences in long lesions. The ATLAS data suggest that
improvements in stent design and a reduction in strut thickness may
contribute to improved clinical outcomes for patients treated with
the TAXUS Liberté Stent."
TAXUS ATLAS "Workhorse" Lesions
Data from 871 patients in the TAXUS ATLAS trial demonstrated
that the durable safety and efficacy profile of the TAXUS Liberté
Stent is maintained at five years in de novo coronary ("workhorse")
lesions. In spite of more complex patients treated with the TAXUS
Liberté Stent, the unadjusted data showed comparable clinical
outcomes between the TAXUS Liberté Stent and a historical
case-matched TAXUS Express(R) Stent control group. The study
reported similar rates of target lesion revascularization (TLR) of
11.0 percent for the TAXUS Liberté Stent vs. 11.5 percent for the
TAXUS Express Stent (p=0.72). Five-year data also showed comparable
rates of cardiac death (5.1 percent for the TAXUS Liberté Stent vs.
4.4 percent for the TAXUS Express Stent, p=0.49) and overall
myocardial infarction (MI) (7.6 percent for the TAXUS Liberté Stent
vs. 8.4 percent for the TAXUS Express Stent, p=0.57). The rate of
ARC(1) definite/probable stent thrombosis at five years was 3.0
percent for the TAXUS Liberté Stent vs. 2.7 percent for the TAXUS
Express Stent (p=0.76).
TAXUS Atlas Small Vessel
Four-year data were presented from the TAXUS ATLAS Small Vessel
trial, which is designed to evaluate the long-term safety and
efficacy of the TAXUS Liberté Atom(TM) (2.25 mm) Stent compared to
lesion-matched patients from the TAXUS V trial treated with either
2.25 or 2.5 mm bare-metal Express(R) Stents or the TAXUS Express(R)
2.25 mm Stent. The TAXUS Liberté 2.25 mm Stent showed significantly
lower rates of TLR (10.8 percent vs. 23.8 percent, p=0.008), target
vessel revascularization (or TVR, 16.5 percent vs. 31.7 percent,
p=0.007), target lesion failure (or TLF, 15.4 percent vs. 30.2
percent, p=0.007) and major adverse cardiac events (or MACE, 21.6
percent vs. 36.5 percent, p=0.02) sustained at four years compared
with the TAXUS Express 2.25 mm Stent and similar significant
reductions compared to the bare-metal Express Stent group. All
stents showed comparable rates of total death, cardiac death, MI
and ARC definite/probable stent thrombosis.
"The TAXUS Liberté 2.25 mm Stent significantly reduced
restenosis and maintained safety outcomes in small vessels compared
to the TAXUS Express 2.25 mm Stent and Express bare-metal stents,"
said Dr. Ormiston. "Since TAXUS Liberté uses the same drug/polymer
coating as TAXUS Express, I believe these improved clinical
outcomes in small vessels likely result from the thinner struts and
improved stent geometry of the TAXUS Liberté Stent."
TAXUS Atlas Long Lesion
Four-year data were also presented from the TAXUS ATLAS Long
Lesion trial, which is designed to assess the safety and efficacy
of the TAXUS Liberté Long (38 mm) Stent in patients with long
coronary lesions compared to a case-matched patient cohort from the
TAXUS IV and V trials treated with TAXUS Express Stents. In a
subgroup analysis of patients treated with a single stent, the
TAXUS Liberté Long Stent showed
significantly reduced rates of target-vessel MI (2.6 percent vs.
12.9 percent, p=0.02) and target-vessel non-Q-wave MI (2.6 percent
vs. 11.3 percent, p=0.03) compared to the TAXUS Express Stent at
four years. Both stent groups demonstrated comparable rates of TLR,
MACE and ARC definite/probable stent thrombosis.
"The TAXUS Liberté Long Stent
maintained a continued long-term safety benefit in patients with
long lesions, resulting in lower target vessel-related MI and a
numerically lower rate of cardiac death compared to the TAXUS
Express Stent," said Dr. Turco.
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
for the remainder of 2010 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 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 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; technological changes that could impact our
existing products or our ability to develop and commercialize
future products; competition; existing 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
substantial 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 attract and retain
qualified personnel; our ability to successfully complete
pre-clinical and clinical development of our products; changes in
our 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 availability of
capital to finance our activities; our ability to restructure and
to service our debt obligations; and any other factors referenced
in our other filings with the applicable Canadian securities
regulatory authorities or the Securities and Exchange Commission
("SEC"). 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,
2009 filed with the SEC on Form 10-K, as amended, and our
quarterly report for the second quarter of 2010 filed with the SEC
on Form 10-Q.
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.
(C)2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty
pharmaceutical and medical device company. 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.
About Boston Scientific Corporation
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad
range of interventional medical specialties. For more information,
please visit: www.bostonscientific.com.
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(1) Academic Research Consortium
SOURCE Angiotech Pharmaceuticals, Inc.
Copyright . 22 PR Newswire