Angiotech Partner announces FDA approval for its TAXUS(TM) Express2(TM) paclitaxel-eluting coronary stent system
04 März 2004 - 11:54PM
PR Newswire (US)
Angiotech Partner announces FDA approval for its TAXUS(TM)
Express2(TM) paclitaxel-eluting coronary stent system Boston
Scientific plans to launch in U.S. immediately VANCOUVER, March 4
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPI; TSX:ANP) today announced that its corporate partner,
Boston Scientific Corporation, has received approval from the U.S.
Food and Drug Administration (FDA) to market its TAXUS(TM)
Express2(TM) paclitaxel-eluting coronary stent system. Boston plans
to launch the product in the United States immediately, and it has
ample inventory in all sizes. The Company launched the TAXUS system
in Europe and other international markets in February of 2003 and
is the leader in those markets today. "We congratulate Boston
Scientific for the scientific and clinical rigor, thoroughness, and
execution of the TAXUS program," said William L. Hunter, President
and CEO of Angiotech. "It is gratifying to see discovery work
pioneered by Angiotech and our academic collaborators culminate in
the launch of a breakthrough therapy that will significantly impact
the lives of thousands of patients." "This approval is a
breakthrough event for the treatment of cardiovascular disease in
the United States," said Jim Tobin, President and Chief Executive
Officer of Boston Scientific. "Broad, consistent clinical data and
extensive real-world experience have clearly demonstrated that
polymer- based delivery of paclitaxel is a safe and effective
therapy that dramatically reduces restenosis. These attributes are
complemented by the outstanding deliverability of the TAXUS stent
system. Today's approval of the TAXUS system makes this
revolutionary new therapy commercially available for the first time
in the United States. We are pleased to provide U.S. physicians
with this innovative technology, which will help so many patients
live better lives." "We are maintaining the financial goals we
outlined at last week's analyst meeting," Tobin added. "Events that
have occurred subsequent to the meeting have not altered our
goals." "The approval of the TAXUS system marks an important
opportunity for clinicians in the United States," said Gregg Stone,
M.D., Vice Chairman of the Cardiovascular Research Foundation at
the Lenox Hill Heart and Vascular Institute in New York, and
Principal Investigator of the TAXUS IV clinical trial. "In
paclitaxel, we now have a multi-functional drug that is safe and
highly effective. The TAXUS system has shown impressive results
across a wide rangeof patients. Its performance has been
particularly impressive in challenging cases such as patients with
diabetes, small vessels and long lesions." "The TAXUS system is a
welcome new ally in the fight against cardiovascular disease," said
Stephen Ellis, M.D., Director of the Sones Cardiac Catheterization
Laboratories at the Cleveland Clinic, and the Co- Principal
Investigator of the TAXUS IV trial. "It offers a well-regarded drug
in combination with a delivery system that is exceptionally
flexible and conformable." The TAXUS product will use the
Express2(TM) coronary stent on the Maverick(TM) balloon system as
its platform. Together, they form the Express2(TM) coronary stent
system, which is known for its excellent deliverability and
conformability. Angiotech Pharmaceuticals, Inc. is dedicated to
enhancing the performance of medical devices and biomaterials
through the innovative use of pharmacotherapeutics. To find out
more about Angiotech Pharmaceuticals, Inc
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), visit our website at
http://www.angiotech.com/. Boston Scientific is a worldwide
developer, manufacturer and marketer of medical devices whose
products are used in a broad range of interventional medical
specialties. Statements contained herein that are not based on
historical or current fact, including without limitation statements
containing the words "anticipates," "believes," "may," "continue,"
"estimate," "expects," "may" and "will" and words of similar
import, constitute "forward-looking statements" within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995. 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. Such factors include, among others, the
following: general economic and business conditions, both
nationally and in the regions in which the Company operates;
technology changes; competition; changes in business strategy or
development plans; the ability to attract and retain qualified
personnel; existing governmental regulations and changes in, orthe
failure to comply with, governmental regulations; liability and
other claims asserted against the Company; and other factors
referenced in the Company's filings with the United States
Securities and Exchange Commission or the Canadian securities
regulators. 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. DATASOURCE: Angiotech Pharmaceuticals,
Inc. CONTACT: Angiotech Pharmaceuticals Contact: Ian Harper
(investors & media) ext. 6933, Rui Avelar (analysts) ext. 6996,
Phone: (604) 221-7676
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