VANCOUVER, May 12 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that
its corporate partner, Boston Scientific Corporation (NYSE: BSX),
has received CE Mark approval for its TAXUS(R) Element(TM)
Paclitaxel-Eluting Coronary Stent System, Boston Scientific's
third-generation drug-eluting stent (DES) technology. This approval
includes a specific indication for the treatment of diabetic
patients. The TAXUS Element Stent System incorporates a platinum
chromium alloy with an innovative stent design and an advanced
catheter delivery system. Boston Scientific has announced that it
plans to launch the TAXUS Element Stent System next month in the
European Union and other CE Mark countries.
"In my experience, the platinum chromium alloy and new stent
design used in the TAXUS Element Stent offer increased flexibility,
visibility and deliverability," said Dean
Kereiakes, M.D., Medical Director at The Christ Hospital
Heart and Vascular Center and The Lindner Research Center in
Cincinnati and the Principal
Investigator for the PERSEUS clinical program. "The Element
platform represents a significant advance in coronary stenting with
performance improvements that could simplify procedures and allow
treatment of a broader range of patients. The combination of the
proven TAXUS drug and polymer with the new Element platform
provides a welcome treatment option."
"As the worldwide prevalence of diabetes continues to increase
dramatically, the diabetic indication for the TAXUS Element Stent
System represents an important benefit for diabetic patients being
treated for coronary artery disease," said Hank Kucheman, Executive Vice President and
Group President, Cardiology, Rhythm and Vascular for Boston
Scientific. "The TAXUS Element Stent System, with the proven
performance of paclitaxel, provides an advanced treatment option
for diabetic patients. This product's unique mechanism of action
helps to inhibit restenosis in high-risk patients with diabetes,
and we are pleased to offer it to these patients."
The TAXUS Element Stent is designed specifically for coronary
stenting and 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(1).
Boston Scientific received CE Mark approval for the PROMUS(R)
Element(TM) Everolimus-Eluting Stent System in October 2009. Both Element systems incorporate
the same platinum chromium alloy, innovative stent design and
advanced catheter delivery system.
In March, Boston Scientific announced 12-month results from its
PERSEUS clinical program demonstrating positive safety and efficacy
outcomes in workhorse lesions for the TAXUS Element Stent System
compared to the TAXUS(R) Express2(TM) Stent System. The results
also reported a similar safety profile and statistically superior
efficacy outcomes in small vessels for the TAXUS Element Stent
compared to a historical control group of patients receiving the
Express(R) bare-metal stent.
"The PERSEUS data confirmed that the proven TAXUS drug and
polymer combination has been successfully transferred to the
Element platform with notable advantages in acute performance,"
added Kucheman.
The PERSEUS clinical program compared the TAXUS Element Stent to
prior-generation Boston Scientific stents in more than 1,600
patients in two parallel trials at 90 centers worldwide.
In the U.S., Boston Scientific expects Food and Drug
Administration approval for the TAXUS Element Stent System in mid
2011 and for the PROMUS Element Stent System in mid 2012. In
Japan, Boston Scientific expects
approval for the TAXUS Element Stent System in late 2011 or early
2012 and for the PROMUS Element Stent System in mid 2012.
In the U.S., the TAXUS Element Stent and the PROMUS Element
Stent are investigational devices and are limited by applicable law
to investigational use only and are 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 first 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.
--------------------------
(1) Based on bench testing. Data on file with Boston Scientific.
SOURCE Angiotech Pharmaceuticals, Inc.