Angiotech's novel 5-FU Central Venous Catheter receives FDA 510(k) clearance
17 April 2008 - 3:00PM
PR Newswire (US)
VANCOUVER, April 17 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced that it has received 510(k) clearance from the U.S. Food
and Drug Administration (FDA) to market its innovative
5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) in the
United States. "The 5-FU CVC represents our first drug-eluting
medical device product to be researched and developed completely
in-house by Angiotech's R & D and clinical teams, without the
aid of a corporate partner," said Dr. William Hunter, President and
CEO of Angiotech. "This is an important milestone in our Company's
history, and we look forward to moving into the commercial phase of
our 5-FU CVC product, as well as developing other implantable
devices that utilize this novel and proprietary anti-infective
technology platform." The clinical data from Angiotech's 960
patient clinical trial comparing its 5-FU CVC with a
chlorhexidine/silver sulfadiazine (CH-SS) coated CVC was recently
presented by clinical investigators at the 28th International
Symposium on Intensive Care and Emergency Medicine in Brussels. The
study met its primary non-inferiority endpoint and there were no
occurrences of clinically evident blood stream infection in
patients treated with Angiotech's 5-FU CVC. About Angiotech's 5-FU
CVC Angiotech has demonstrated that 5-FU, a well-known and FDA
approved drug, has effectively demonstrated its ability to prevent
catheter-related infections as compared with CH-SS coated
catheters. In addition, since 5-FU is not routinely used as either
a systemic antibiotic or a hospital antiseptic, there may be a
reduced risk to the hospital or the community at-large of creating
a "super-bug" that is resistant to useful classes of antibiotics
and antiseptics and may make infection control more complex. The
alarming increase in microbial resistance is one of the Centers for
Disease Control and Prevention's top concerns, and the 5-FU CVC
represents an effective and important step towards preserving
valuable antibiotic and antiseptic agents which currently have
widespread use in the hospital and community settings. The
principle behind using 5-FU on a CVC is that the drug acts through
multiple pathways to inhibit bacterial growth and metabolic
functions of most microorganisms. Adding a very minute amount of
5-FU to the surface of a device makes that surface a hostile
environment for a microorganism, with unchanged tolerability for
the patient. This reduction in colonization by bacteria may have a
net effect of reducing biofilm burden on the implanted devices,
making them less likely to serve as reservoirs for additional
infection. 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," "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 strategies or future
actions, our targets, expectations for our financial condition and
the results of, or outlook for, our operations, research
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 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, both
nationally and in the 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; adverse
results or unexpected delays in drug discovery and clinical
development processes; 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 and to expand commercialization activities
or consummate acquisitions; the accuracy of our estimations of the
size of the market, and the potential market, for our products in
specific disease areas; sales numbers and future guidance publicly
provided by Boston Scientific Corporation regarding sales of their
paclitaxel-eluting coronary stent products; 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 attract and retain
qualified personnel; our ability to successfully complete
preclinical and clinical development of our products; changes in
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 ability of Boston
Scientific Corporation to successfully manufacture, market and sell
their paclitaxel-eluting coronary stent products; the continued
availability of capital to finance our activities; our ability to
achieve the financial benefits expected as a result of the
acquisition of American Medical Instruments Holdings, Inc.; and any
other factors referenced in our annual information form and other
filings with the applicable Canadian securities regulatory
authorities or the SEC. 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 press release to reflect future results, events or
developments. 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:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. CONTACT: Deirdre Neary, Manager,
Investor Relations, Angiotech Pharmaceuticals, Inc., (604)
222-7056, DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT:
Deirdre Neary, Manager, Investor Relations, Angiotech
Pharmaceuticals, Inc., (604) 222-7056,
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