Moderate-release TAXUS(R) Express(TM) coronary stent system demonstrates sustained long-term outcomes in high-risk patients
16 Mai 2006 - 9:39PM
PR Newswire (US)
TAXUS VI results support positive safety and efficacy profile
VANCOUVER, May 16 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) today announced that
its corporate partner Boston Scientific Corporation ("BSC") has
announced three-year follow-up data from its TAXUS VI clinical
trial. The data demonstrated that the safety and efficacy benefits
associated with a moderate-release formulation of the TAXUS(R)
Express(TM) paclitaxel-eluting stent system were maintained at
three years. Analysis of the data was presented by Keith D.
Dawkins, M.D., Co- Principal Investigator of the trial. BSC made
the announcement at the annual Paris Course on Revascularization
(EuroPCR). The randomized, double-blind, controlled study of 448
patients at 44 international sites is designed to assess the TAXUS
moderate-release paclitaxel-eluting coronary stent system in
reducing restenosis in high-risk patients, including long de novo
lesions with overlapping stents, small vessels and diabetics.
Lesion size ranged from 18 - 40 mm in length and 2.5 - 3.75 mm in
diameter. TAXUS VI is the first randomized, controlled clinical
trial to demonstrate durability of drug-eluting stents in complex
lesions at three years. Follow-up included 98.2 percent of the
patients enrolled at three years (432 out of 440). "The three-year
data from TAXUS VI demonstrates sustained safety and efficacy of
the moderate-release TAXUS paclitaxel-eluting stent system in
patients with long lesions treated with multiple, overlapping
stents," said Dr. Dawkins. "It's reassuring to see that even in the
most complex lesions ever studied in a drug-eluting stent trial,
moderate-release TAXUS stents offer sustained target lesion
revascularization benefits over time with no compromise to safety."
Continued efficacy ------------------ The study's results indicate
a continued significant reduction in target lesion
revascularization (TLR, or retreatment rate) as compared to the
bare-metal stent control group at three years. The study reported a
three-year TLR rate of 11.7 percent (25/213) for the TAXUS group,
as compared with 21.2 percent (46/217) for the control group
(P(equal sign)0.0082) (only four TLR events were reported between
two and three years for the TAXUS group). The rate of patients
living free of TLR events was 88.4 percent at three years for the
TAXUS group, as compared to 79.1 percent for the bare-metal stent
control group. Long-term safety ---------------- The three-year
results for TAXUS VI support long-term safety with the increased
levels of paclitaxel in the moderate-release formulation used in
the study. Even with an in vitro dosing rate 8-10 times greater
than the commercialized slow-release formulation, no compromise in
safety was observed. Stent thromboses remained unchanged between
two and three years at a low 0.9 percent for both the TAXUS group
and the control group. BSC launched the slow-release formulation
TAXUS Express(2) paclitaxel-eluting coronary stent system in Europe
and other international markets in February 2003 and in the United
States in March 2004. The TAXUS Express moderate-release
paclitaxel-eluting stent is not approved for commercial
distribution. BSC acquired worldwide exclusive rights from
Angiotech to use paclitaxel to coat its coronary stent products and
has co-exclusive rights to other vascular and non-vascular
products. About Angiotech Pharmaceuticals, Inc.
------------------------------------- Founded in 1992, Angiotech
Pharmaceuticals, Inc. is a global specialty pharmaceutical and
medical device company, with 14 facilities in 6 countries and over
1,500 dedicated employees, that discovers, develops and markets
innovative, minimally invasive treatment solutions for diseases or
complications associated with medical device implants, surgical
interventions and acute injury. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please
visit our website at http://www.angiotech.com/. Statements
contained in this press release or in our other written or oral
public communications that are not based on historical or current
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
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. Such forward-looking statements are based on
assumptions that 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. Forward-looking statements in this release include the
statements regarding: the applicability of the clinical data to
patient. These statements are subject to risks and uncertainties
that could cause actual results to differ materially from those
projected. These risks and uncertainties include, among others, the
possibility of a change in the regulatory environment in Europe and
the risks and uncertainties described in Angiotech's filings with
the United States Securities and Exchange Commission or the
Canadian securities regulators. The forward looking statements are
also based on a number of assumptions, including the applicability
of the clinical data to patient populations; that the study results
were collected and reported in accordance with the study protocol;
and that the study results have been accurately interpreted. Given
these uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. The Company does not
assume the obligation to update any forward-looking statements. FOR
ADDITIONAL INFORMATION: --------------------------- Analysts and
Investors: Janet Craig VP, Investor Relations and Corporate
Communications Angiotech Pharmaceuticals, Inc. (604) 221-6933
Media: Jodi Regts Manager, Corporate Communications Angiotech
Pharmaceuticals, Inc. (604) 221-7930 DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Analysts and Investors: Janet Craig,
VP, Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-6933; Media: Jodi Regts, Manager,
Corporate Communications, Angiotech Pharmaceuticals, Inc., (604)
221-7930
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