VANCOUVER, June 11 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced Cook
Medical, a license holder of Angiotech's paclitaxel technology, has
submitted its Pre-Market Approval (PMA) application to the U.S.
Food and Drug Administration (FDA) for the company's unique
polymer-free Zilver(R) PTX(R) Drug-Eluting Peripheral Stent.
Intended for use in patients with peripheral arterial disease (PAD)
in the superficial femoral artery (SFA), Zilver PTX is a
self-expanding, highly durable nitinol stent that uses a
proprietary, polymer-free technology to deliver a locally
therapeutic dose of paclitaxel, an anti-proliferative drug, to the
target lesion.
Cook's PMA submission includes data from the randomized portion
of the ongoing Zilver PTX clinical trial, the largest study of its
kind for the endovascular treatment of PAD in the SFA. Encompassing
a global single arm registry and a randomized study involving 1,276
total patients including diabetics, symptomatic patients and those
with complex lesions, the 479 patients enrolled in the randomized
study and the 787 in the single arm study are experiencing clinical
improvement, excellent stent durability (i.e., fracture
resistance), high rates of event-free survival and freedom from
target lesion revascularization. Patency data from the single-arm
study was reported at 86.2 percent at 12 months at EuroPCR last
month.
"PAD currently affects approximately eight million men and women
over the age of 40 in the United
States," said Michael Dake,
M.D., professor in the Department of Cardiothoracic Surgery at
Stanford University Medical School,
medical director of the Cath/Angio Laboratories at Stanford University Medical Center and the trial's
principal investigator. "The medical community considers
percutaneous transluminal angioplasty to be the treatment of choice
for patients with PAD, but Zilver PTX shows promise for being a
superior method for improving the quality of life of these
individuals."
"Filing for pre-market approval with the FDA is an exciting step
forward for us in bringing Zilver PTX to market in the United States," said Rob Lyles, vice president and global leader of
Cook Medical's Peripheral Intervention division. "Cook is committed
to continually improving the efficacy and safety of our products
with the overall aim of improving patient outcomes."
PMA submission is a critical step in the product development
process, giving the FDA the appropriate information to evaluate the
safety and efficacy of a medical device.
About Zilver PTX
The Zilver PTX stent was CE Marked in August 2009 and has been made available in
Europe since September of 2009. It
is the first drug-eluting stent indicated for treating PAD in the
SFA, an often difficult-to-treat blood vessel in the leg.
Upon deployment, the Zilver PTX stent expands and holds open the
artery to restore blood flow. It then delivers the drug paclitaxel
to the cells in the vessel wall to reduce the risk of new blockages
forming. In a major advance over previous drug-eluting
technologies, the Zilver PTX achieves targeted drug delivery
without using a polymer to adhere the drug to the stent body. This
eliminates the potential patient risks associated with
polymer-coated devices, including clot formation and
inflammation.
Cook licenses the rights to use paclitaxel on peripheral stents
and other non-coronary medical devices from Angiotech. In
the United States, the Zilver PTX
Drug-Eluting Stent is an investigational device not available for
sale at this time.
About PAD
PAD is caused by atherosclerosis - the build-up of fatty
deposits (atheroma) within the lining of the arteries. The most
common symptom of PAD is leg pain during exercise. Over time the
arteries may narrow due to atherosclerosis, resulting in a
reduction in blood flow. Severely reduced blood flow in the limbs
is also known as critical limb ischemia (CLI). It is characterized
by leg pain at rest, non-healing wounds, and gangrene, and may lead
to amputation of the limb.
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
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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
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 Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical
devices now commonly used to perform minimally invasive medical
procedures throughout the body. Today, the company integrates
medical devices, drugs and biologics to enhance patient safety and
improve clinical outcomes. Since its inception, Cook has operated
as a family-held private corporation. For more information, visit
www.cookmedical.com.
Zilver PTX is a trademark of William Cook Europe A/S.
SOURCE Angiotech Pharmaceuticals, Inc.