VANCOUVER, March 15 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that
its corporate partner, Boston Scientific Corporation (NYSE: BSX),
announced 12-month results from its PERSEUS clinical program that
demonstrated positive safety and efficacy outcomes in workhorse
lesions for the platinum chromium TAXUS(R) Element(TM)
Paclitaxel-Eluting Stent System compared to the TAXUS(R)
Express(2)(TM) Paclitaxel-Eluting 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.
Analysis of the data was presented at the American College of
Cardiology Annual Scientific Sessions during a late-breaking trial
session by 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.
"We are very encouraged by the one-year data demonstrating
positive safety and efficacy outcomes for the TAXUS Element Stent
and its innovative platinum chromium alloy," said Dr. Kereiakes.
"In my experience, the TAXUS Element Stent offers increased
flexibility, visibility and deliverability compared with currently
available products. The PERSEUS data confirm that the proven TAXUS
drug and polymer combination has been successfully transferred to
the Element platform with excellent performance and comparable
safety."
The TAXUS Element Stent is designed specifically for coronary
stenting. 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).
The PERSEUS clinical program compares the TAXUS Element Stent to
prior-generation stents in more than 1,600 patients in two parallel
trials at 90 centers worldwide.
Workhorse trial
---------------
The pivotal PERSEUS Workhorse trial is evaluating the safety and
efficacy of the TAXUS Element Stent compared to Boston Scientific's
first-generation TAXUS Express Stent in 1,262 patients with de novo
lesions.
The prospective, randomized (3:1) trial met its primary endpoint
of non-inferiority for target lesion failure(2) (TLF) at 12 months
with rates of 5.6 percent for the TAXUS Element Stent and 6.1
percent for the TAXUS Express Stent(3). The secondary endpoint of
in-segment percent diameter stenosis at nine months as measured by
quantitative coronary angiography (QCA) was also met.
The Workhorse results also demonstrated similar safety for the
TAXUS Element Stent as demonstrated by low rates of Major Adverse
Cardiac Events (MACE) and stent thrombosis. All components of MACE,
including cardiac death, myocardial infarction (MI) and target
vessel revascularization (TVR) were similar to the TAXUS Express
Stent control. A numerically lower rate of non-Q-wave MI for the
TAXUS Element Stent resulted in lower overall MI (2.2 vs. 2.9
percent, p=0.48). Stent thrombosis rates using the Academic
Research Coalition (ARC) definite/probable definition were
statistically similar for the TAXUS Element Stent and the TAXUS
Express Stent (0.4 and 0.3 percent, p(greater than)0.99).
Small Vessel trial
------------------
Results were also presented from the PERSEUS Small Vessel trial,
a single-arm study which compares the TAXUS Element Stent in 224
patients with small vessels ((greater than or equal to)2.25 to
(less than)2.75 mm in diameter and (less than or equal to)20 mm in
length) to a matched historical control group of 125 patients
treated with the Express bare-metal stent. The trial met its
primary endpoint of superiority for in-stent late loss at nine
months with unadjusted values of 0.38 mm for the TAXUS Element
Stent and 0.80 mm for the Express Stent (p(less than)0.001). The
trial also met its secondary endpoint of superiority for TLF at 12
months, showing a statistically significant reduction with an
unadjusted rate of 7.3 percent for the TAXUS Element Stent compared
to a pre-specified performance goal of 19.5 percent (p(less
than)0.001) based on historical outcomes for the control stent. The
propensity-adjusted MACE rates were significantly lower for the
TAXUS Element Stent compared to the bare-metal control stent (10.5
vs. 30.4 percent, p=0.002), showing a safety benefit for the TAXUS
Element Stent. Stent thrombosis rates using the ARC
definite/probable definition were comparable for the TAXUS Element
Stent and Express Stent (0.3 vs. 0.6 percent, p=0.65).
"The PERSEUS trials build on the extensive data from the TAXUS
clinical program and extend the consistent outcomes seen in the
TAXUS trials to the novel Element Stent platform," said
Louis Cannon, M.D., of the Cardiac
and Vascular Research Center of Northern
Michigan in Petoskey,
Michigan and the trial's Co-Principal Investigator. "With
the positive outcomes of the TAXUS Element Stent in workhorse
lesions and the superior efficacy data in small vessels, platinum
chromium promises to offer significant advantages in acute
performance with no compromise to safety."
Clinical data from the PERSEUS trials will support regulatory
approval of the TAXUS Element Paclitaxel-Eluting Stent System in
Europe, the U.S. and Japan. Boston Scientific is evaluating its
PROMUS(R) Element(TM) Everolimus-Eluting Stent System in the
PLATINUM clinical trial, which completed enrollment of 1,531
patients in September 2009 at 133
sites worldwide. PLATINUM is a randomized, controlled, pivotal
trial designed to support U.S. and Japanese approval of the PROMUS
Element Stent System. Results are expected to be presented in early
2011.
Boston Scientific received CE Mark approval for the PROMUS
Element Stent System in October 2009
and expects CE Mark approval for the TAXUS Element Stent System in
the second quarter of this year. In the U.S., the Company expects
FDA approval for the TAXUS Element Stent System in the middle of
next year and for the PROMUS Element Stent System in the middle of
2012. In Japan, the Company
expects approval for the TAXUS Element Stent System in late 2011 or
early 2012 and for the PROMUS Element Stent System in the middle of
2012.
The TAXUS Element Stent and the PROMUS Element Stent are
investigational devices in the U.S. 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 2009 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 regulations and
changes in, or the failure to comply with, governmental
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,
2008 filed with the SEC on Form 10-K/A, as amended, and our
quarterly reports for the first, second and third quarters of 2009
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.
-------------------------------
(1) Based on bench testing. Data on file with Boston Scientific.
(2) TLF is defined as ischemia-driven target lesion revascularization
(TLR) or myocardial infarction/cardiac death related to the target
vessel. Complete trial design at Allocco et al., Trials 2010, 11:1.
(3) Bayesian probability of non-inferiority = 99.96 percent.
SOURCE Angiotech Pharmaceuticals, Inc.