VANCOUVER, Sept. 22 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) announced that its
corporate partner, Boston Scientific Corporation (NYSE: BSX), has
released results from an analysis of 1,166 patients from its
PERSEUS clinical program comparing the performance of the TAXUS(R)
Element(TM) Paclitaxel-Eluting Coronary Stent System in diabetic
versus non-diabetic patients. Results demonstrated that despite the
known increased risk of restenosis for diabetics versus
non-diabetics in patients undergoing coronary revascularization,
the TAXUS Element Stent had comparable levels of target lesion
revascularization (TLR) and late loss in both diabetic and
non-diabetic patients. Analysis of the data was presented by
Louis A. Cannon, M.D., of the
Cardiac and Vascular Research Center of Northern Michigan in Petoskey, Michigan, and Co-Principal
Investigator of the PERSEUS clinical program, at the Cardiovascular
Research Foundation's annual Transcatheter Cardiovascular
Therapeutics scientific symposium in Washington, D.C.
"The PERSEUS diabetic subset data showed that the TAXUS Element
Stent mitigated the impact of diabetes as a risk factor for
restenosis following stenting procedures in the patients studied,"
said Dr. Cannon. "At one year, no significant differences in
measures of stent efficacy were observed between the two patient
groups. Diabetic status was not a predictor of re-intervention in
patients treated with the TAXUS Element Stent."
The PERSEUS diabetic analysis included clinical outcomes at one
year among 314 diabetic patients and 852 non-diabetic patients
treated with the TAXUS Element Stent from the PERSEUS Workhorse and
Small Vessel clinical trials. Due to significant disparity in
baseline characteristics between diabetic and non-diabetic
patients, propensity score analysis was used to allow for
adjustment of baseline differences (other than the presence of
diabetes) between the two groups.
Results showed that the TAXUS Element Stent maintained
comparable rates of TLR at one year, whether adjusted or
unadjusted, in the diabetic and non-diabetic patient populations
(5.5 percent vs. 4.1 percent, p=0.43, adjusted). The adjusted and
unadjusted rates of target lesion failure (TLF) at one year
(defined as ischemia-driven TLR, or MI/cardiac death related to the
target vessel) were also similar between the patient groups (7.5
percent vs. 5.4 percent, p=0.31, adjusted). Adjusted one-year rates
of MACE, cardiac death, MI and ARC(1) definite/probable stent
thrombosis showed no differences between the two populations
(p-values of 0.14, 0.12, 0.38, and 0.77, respectively).
Nine-month adjusted angiographic outcomes showed similar
in-segment late loss in diabetics and non-diabetics (0.23 mm vs.
0.19 mm, p=0.52). Rates of late loss for the TAXUS Element Stent
were numerically lower than rates in prior studies for the TAXUS
Express(R) and TAXUS Liberté(R) Stents(2).
"The PERSEUS diabetic analysis reinforces the historically
consistent performance of paclitaxel in diabetic patients compared
to non-diabetic patients," said Keith D.
Dawkins, M.D., Senior Vice President and Chief Medical
Officer for Boston Scientific's Cardiology, Rhythm and Vascular
Group. "The paclitaxel-based TAXUS Element Stent has a unique
mechanism of action that helps inhibit restenosis across a wide
variety of patients with coronary artery disease."
The TAXUS Element Stent leverages the performance advantages of
the Element platform with a decade of clinical success from the
TAXUS program. The novel stent architecture and proprietary
platinum chromium alloy combine to offer greater radial strength
and flexibility. The stent architecture helps create consistent
lesion coverage and drug distribution while improving
deliverability, which is enhanced by an advanced catheter delivery
system. The higher density alloy provides superior visibility and
reduced recoil while permitting thinner struts compared to
prior-generation stents(3).
"We are pleased to see the strong performance of the TAXUS
Element Stent in both the overall population of the PERSEUS trial
and the diabetic patient subset," said Hank
Kucheman, Executive Vice President and Group President,
Cardiology, Rhythm and Vascular for Boston Scientific. "As the
worldwide prevalence of diabetes continues to increase
dramatically, these findings are very encouraging for physicians
and their patients."
Diabetes is generally associated with an increased risk of
cardiovascular events and patients with diabetes are more likely
than non-diabetic patients to require repeat procedures due to a
higher incidence of restenosis following angioplasty and
stenting.
In March, Boston Scientific announced one-year results from its
PERSEUS clinical program demonstrating positive safety and efficacy
outcomes for the TAXUS Element Stent System compared to
prior-generation Boston Scientific stents in more than 1,486
patients in two parallel trials at 90 centers worldwide.
The TAXUS Element Paclitaxel-Eluting Stent System received CE
Mark approval in May, which included a specific indication for the
treatment of diabetic patients. Boston Scientific expects U.S. Food
and Drug Administration approval for the TAXUS Element Stent
System(4) in mid 2011. In Japan,
Boston Scientific expects approval for the TAXUS Element Stent
System in late 2011 or early 2012.
In the U.S., the TAXUS Element (ION) Stent is an investigational
device and is limited by applicable law to investigational use only
and is not available for sale.
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
(2) The TAXUS Express and TAXUS Liberté Stent Systems are not
specifically indicated for diabetic patients in the U.S.
(3) Based on bench testing. Data on file with Boston Scientific.
(4) The TAXUS Element Stent System will be commercialized as the ION(TM)
Paclitaxel-Eluting Platinum Chromium Coronary Stent System in the
U.S.
SOURCE Angiotech Pharmaceuticals, Inc.
Copyright . 22 PR Newswire