Angiotech's corporate partner, Boston Scientific, submits final modules to FDA for approval of second-generation small vessel and long lesion stents



    
    Journal of American College of Cardiology publishes positive ATLAS
    clinical data
    

    VANCOUVER, Feb. 5 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ:   ANPI,
TSX: ANP), a global specialty pharmaceutical and medical device company, today
announced that its corporate partner, Boston Scientific, has submitted the
final modules for pre-market approval (PMA) for both its TAXUS(R) Liberté(R)
Atom(TM) Paclitaxel-Eluting Coronary Stent System and its TAXUS(R) Liberté
Long(TM) Paclitaxel-Eluting Coronary Stent System to the U.S. Food and Drug
Administration (FDA). If approved, the TAXUS Liberté Atom Stent will become
Boston Scientific's second 2.25 mm diameter drug-eluting stent (DES) available
in the United States. It will then likely succeed the TAXUS Express(TM) Atom
Stent, which is Boston Scientific's first approved small stent and the only
DES currently approved by the FDA to treat small vessels. The TAXUS Liberté
Long Stent is designed to be the first 38 mm drug-eluting stent available in
the U.S. and will further expand this leading DES portfolio.
    "We are pleased to have a second-generation small vessel DES and the U.S.
market's first long DES under review by the FDA," said Jim Tobin, President
and Chief Executive Officer of Boston Scientific. "The rapid adoption of our
recently approved TAXUS Express Atom Stent confirms the need for an expanded
DES size matrix to treat the wide range of vessel anatomies seen in daily
clinical practice."
    These PMA submissions include clinical data from the global, multi-center
TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) studies, designed to
compare the performance of the TAXUS Liberté Atom and TAXUS Liberté Long
Stents with Boston Scientific's first-generation TAXUS Express Stent. While
the second-generation TAXUS Liberté Stent uses identical drug dose, polymer
and release kinetics as the TAXUS Express Stent, it features thinner struts
and a uniform architecture specifically designed for drug delivery.
    One-year results from the TAXUS ATLAS SV and LL studies were published in
the December 2008 issue of the Journal of American College of Cardiology. The
studies both met their primary endpoint of non-inferior, nine-month,
in-segment diameter stenosis versus the TAXUS Express Stent control group.
They reported a significant reduction in small vessel in-stent restenosis and
major adverse coronary events (MACE) in patients treated with the TAXUS
Liberté Atom Stent, and a significantly reduced rate of myocardial infarction
(heart attack) in patients with long lesions treated with the TAXUS Liberté
Long Stent.
    "In the ATLAS study, lower target lesion revascularization (TLR) rates
contributed to a significantly lower rate of MACE, including heart attacks,
with the TAXUS Liberté Atom Stent," said Mark A. Turco, M.D., Director of the
Center for Cardiac and Vascular Research, Washington Adventist Hospital, and
Co-Principal Investigator of the ATLAS trial. "The thinner struts of the TAXUS
Liberté Atom Stent are designed to improve its deliverability and
conformability, which is important when treating small vessels. The TAXUS
Liberté Stent also features an advanced stent cell geometry that has been
designed to allow for more consistent drug distribution."
    Patients with small vessels treated with the TAXUS Liberté Atom Stent
reported significantly lower nine-month angiographic in-segment late loss
(0.16 mm vs. 0.32 mm, p=0.0146), reduced nine-month angiographic restenosis
(18.5% vs. 32.7%, p=0.0219), reduced 12-month TLR (6.1% vs. 16.9%, p=0.0039),
and reduced rates of stent thrombosis (0.4% vs. 1.5%, p=0.39). Patients with
long lesions treated with the TAXUS Liberté Long Stent reported a
significantly reduced 12-month rate of myocardial infarction (1.4% vs. 6.5%,
p= 0.0246) as well as a trend toward fewer stent thromboses (0% vs. 0.7%,
p=0.48).
    Boston Scientific remains the overall drug-eluting stent market leader in
the United States, with a 49 percent share of the market in December. The
Company released three major DES products in the United States in 2008
including the TAXUS Express Atom Stent and the TAXUS Liberté Stent. Boston
Scientific expects to launch its third-generation drug-eluting stents,
including the TAXUS Element(TM) Paclitaxel-Eluting Coronary Stent, in Europe
later this year.
    The TAXUS Liberté Atom, TAXUS Liberté Long and TAXUS Element stents are
investigational devices and are restricted under U.S. law to investigational
use only.

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    Given these uncertainties, assumptions and risk factors, readers are
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    (C)2009 Angiotech Pharmaceuticals, Inc.  All Rights Reserved.

    Boston Scientific Corporation 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) Liberté(R) Atom(TM) and Long(TM) are registered trademarks of
Boston Scientific Corporation.

    About Angiotech Pharmaceuticals

    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:   ANPI, TSX: ANP),
please visit our website at www.angiotech.com.





For further information:

For further information: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
dede.sheel@fdashtonpartners.com

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