Angiotech Pharmaceuticals,
Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and
medical device company, today announced the initiation of a European study
evaluating the safety and efficacy of the Vascular Wrap(TM)
paclitaxel-eluting mesh ("Vascular Wrap(TM)") after surgical implantation
with an ePTFE vascular graft in the upper extremity for hemodialysis
vascular (AV) access.
"Patients with end-stage renal disease today face the high probability
that their AV graft will fail within the first year of use. The Vascular
Wrap (TM) product has the potential to save these dialysis patients from
the further health and financial burdens of repeated surgeries and
additional hospitalizations," said Dr. Eric Chemla, coordinating
investigator of the study based at St. George's Healthcare NHS Trust in
London, UK.
"We believe that the Vascular Wrap(TM) product will be a key catalyst
for building out an Angiotech-branded, vascular franchise. We expect that
the results from this European study and the ongoing U.S. pivotal trial
will form the groundwork for expanding the potential indications for the
Vascular Wrap (TM) technology," said Dr. William Hunter, President and CEO
of Angiotech.
The European (AV) study will involve approximately 198 patients at 20
centres in Europe. The first patient was enrolled by Dr. Ali Bakran at the
Royal Liverpool University Hospital. Within one year following vascular
access surgery, the patency of the Vascular Wrap(TM) combined with an ePTFE
vascular graft will be compared to a control group of patients who receive
the standard of care, which is an ePTFE vascular graft alone.
In March 2007, Angiotech launched a similar pivotal trial in the United
States, which is also designed to evaluate the safety and efficacy of the
Vascular Wrap(TM) after surgical implantation with an ePTFE vascular graft
in the upper extremity for AV access.
In November 2006, Angiotech reported results from its European
first-in-man study examining the safety and clinical performance of the
Vascular Wrap(TM) when used to treat patients suffering from advanced
peripheral arterial disease (PAD) in their lower limbs. Based on the
strength of this two-year data, Angiotech submitted an application for a CE
Mark for its Vascular Wrap(TM) paclitaxel-eluting mesh/ePTFE vascular graft
combination product for this indication. Upon receipt of a CE Mark,
Angiotech would commence commercialization of its Vascular Wrap(TM) product
in the EU and certain other countries outside of the United States.
About the European (AV) Study
The European (AV) study is a multi-centre, randomized, single-blind
study to assess the safety and effectiveness of the Vascular Wrap(TM) after
surgical implantation with an ePTFE vascular graft in the upper extremity
for hemodialysis vascular (AV) access. It is expected that results from
this study will serve as a base of European experience for CE Mark
submission, along with supporting data from the U.S. pivotal trial.
Note on 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," "could", "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. Forward-looking statements may involve,
but are not limited to, comments with respect to our objectives and
priorities for 2007 and beyond, our strategies or future actions, our
targets, expectations for our financial condition and the results of, or
outlook for, our operations, research development and further product and
drug development. Such forward-looking statements also 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 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, both
nationally and in the regions in which we operate; technological changes
that impact our existing products or our ability to develop and
commercialize future products; competition; changes in business strategy or
development plans; the ability to attract and retain qualified personnel;
existing governmental regulations and changes in, or the failure to comply
with, governmental regulations; adverse results or unexpected delays in
drug discovery and clinical development processes; 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; dependence upon, and
relationships with strategic alliance partners to develop and commercialize
products and services based on our work; our ability to obtain rights to
technology from licensors; liability for patent claims and other claims
asserted against us; the requirement for substantial funding to conduct
research and development and to expand commercialization activities or
consummate acquisitions; the size of the market and the potential market
for our products in specific disease areas, other factors referenced in our
annual information form and other filings with the applicable Canadian
securities regulatory authorities or the Securities and Exchange
Commission; and any other factors that may affect performance. In addition,
our business is subject to certain operating risks that may cause the
actual results expressed or implied by the forward-looking statements in
this report to differ materially from our actual results. These operating
risks include: our ability to successfully complete preclinical and
clinical development of our products; the ability to obtain and enforce
timely patent and other intellectual property protection for our technology
and products; decisions, and the timing of decisions, made by health
regulatory agencies regarding approval of our technology and products; the
ability to complete and maintain corporate alliances relating to the
development and commercialization of our technology and products; market
acceptance of our technology and products; the competitive environment and
impact of technological change; the continued availability of capital to
finance our activities; our ability to integrate into our business the
operations of AMI; and, our ability to achieve the operational and other
synergies and the other commercial or financial benefits expected as a
result of the acquisition of AMI.
Given these uncertainties, assumptions and risk factors, readers are
cautioned not to place undue reliance on such forward-looking statements.
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 report to reflect future results, events or
developments.
(TM) Vascular Wrap is a trademark of Angiotech Pharmaceuticals, Inc.
(C) 2007 Angiotech Pharmaceuticals, Inc. All rights reserved.
About Angiotech
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 angiotech.
Angiotech Pharmaceuticals, Inc.
angiotech