Angiotech announces intent to file 510(k) for its innovative 5-FU Central Venous Catheter (CVC) based on positive results from p
09 Oktober 2007 - 10:43PM
PR Newswire (US)
VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced that it intends to file Premarket Notification 510(k)
documents with the U.S. Food and Drug Administration (FDA) for its
innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central
Venous Catheter (CVC). "After reviewing the data from our recently
completed clinical trial, we are extremely pleased that the 5-FU
CVC pivotal study has hit its primary efficacy endpoint while
showing an excellent safety profile. We are looking forward to
presenting the full data set in a scientific symposium at the
upcoming Critical Care Congress in February," said Dr. William
Hunter, President and CEO of Angiotech. "Based on the positive
results from the U.S. pivotal trial, we will prepare a 510(k)
package, which we expect to submit to the FDA in the fourth quarter
of 2007. This is another important step towards commercializing our
5-FU CVC product line and our 5-FU anti-infective platform,"
continued Dr. Hunter. "This is an exciting milestone for Angiotech.
Our R&D efforts are striving to address two of the most common
problems in surgery and medical devices: restenosis following
vascular injury and infection related to medical device
implantation. We continue to work towards achieving success in one
of the most challenging areas of medical device development by
deriving new and useful applications for our leading drug
platforms, paclitaxel and 5-FU, and taking them from their early
stages in the lab to their actual clinical use," added Dr. Jeff
Walker, Senior VP, Research and Development for Angiotech. The 5-FU
CVC is expected to be Angiotech's first product line to be
completely researched, developed and commercialized using internal
resources, personnel and technologies, many of which were obtained
through previous acquisitions completed by Angiotech. In July 2007,
Angiotech completed enrolment of 960 patients in the clinical trial
of its 5-FU CVC, which was one of the largest CVC studies ever
conducted. Designed as a randomized, single-blind,
active-controlled, two-arm, multi-center clinical study, the
primary objective is to compare the Angiotech 5-FU CVC to a leading
anti-infective catheter with regards to preventing bacterial
colonization. Angiotech plans to present the 5-FU CVC pivotal study
results at the "37th Critical Care Congress" hosted by the Society
of Critical Care Medicine, which will be held on February 2-6, 2008
at the Hawaii Convention Center. Pending the receipt of all
necessary regulatory approvals, Angiotech anticipates launching the
commercial 5-FU CVC product line in 2008. About Central Venous
Catheters (CVC) Central venous catheters (CVC) are usually inserted
into critically ill patients for extended periods of time to
administer fluids, drugs, and nutrition, as well as facilitate
frequent blood draws. One of the complications associated with CVC
implantation is infection, which can occur when bacteria
contaminate the catheter. CVC infections that progress to
bloodstream infections, or septicemia, can become life threatening.
About Catheter-Related Infections In the U.S., the cost per
catheter-related infection can range from $3,700 to $29,000(1). In
addition, the Centers for Disease Control and Prevention (CDC) has
raised concerns about the overuse of traditional antibiotics, which
can contribute to an increase in the antibiotic resistance of
bacteria. About Angiotech's 5-FU CVC Angiotech believes that 5-FU,
a well-known and approved compound, has the potential to be used as
a coating to prevent catheter-related infections as effectively as
traditional antiseptics and antibiotics. In addition, since 5-FU
has no clinical application as either a systemic antibiotic or a
hospital antiseptic, there is little risk to the hospital or the
community at-large of creating a "super-bug" that is resistant to a
useful class of antibiotic and can make infection control more
complex. The principle behind using 5-FU on a CVC is that the drug
appears to effectively interrupt the colonization of an implanted
medical device by those micro-organisms that typically gain
entrance to the bloodstream via the local skin penetration of
implanted catheters. This reduction in colonization by bacteria may
have a net effect of reducing biofilm burden on the implanted
catheters, 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," "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, our estimation of potential market size, 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.
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/. (1) Mermel, LA. Prevention of
intravascular catheter-related infections. Ann Intern Med. 2000;
132:391-402. CONTACT: Jodi Regts, Senior Manager, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-7930, ; Analysts and Investors: Deirdre Neary,
Manager, Investor Relations, Angiotech Pharmaceuticals, Inc., (604)
222-7056, DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Jodi
Regts, Senior Manager, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (604) 221-7930, ;
Analysts and Investors: Deirdre Neary, Manager, Investor Relations,
Angiotech Pharmaceuticals, Inc., (604) 222-7056,
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