Angiotech announces Vascular Wrap(TM)/Lifespan(R) Vascular Graft combination product receives designation of "device" for U.S. p
20 Dezember 2005 - 3:00PM
PR Newswire (US)
VANCOUVER, Dec. 20 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today
announced that its Vascular Wrap(TM) Paclitaxel-Eluting
Mesh/Lifespan(R) Vascular Graft has received a designation of
"device" from the Office of Combination Products at the U.S. Food
and Drug Administration (FDA). This designation of "device" has
historically indicated a faster regulatory and commercial timeline
for a product as compared to when the FDA considers a combination
product to be a "drug". Angiotech plans to initiate the PREVAIL
(Paclitaxel Releasing Extra- Vascular Anastomosis Implant &
Lifespan(R) Graft) clinical trial in the first half of 2006.
PREVAIL will be designed to assess the efficacy and safety of
Angiotech's pioneering Vascular Wrap(TM) Paclitaxel-Eluting
Mesh/Lifespan(R) Vascular Graft combination product in patients
with end-stage renal disease who are undergoing hemodialysis. As a
combination product, the graft serves as an access port for
hemodialysis and the intent of the drug-eluting mesh is to prevent
the scar formation that often leads to graft failure. Currently,
approximately 50 percent of these grafts require replacement or
revision within one year as a result of scar formation. The cost of
these graft failures is significant, estimated to be an additional
US $55,000 per failure. "We consider this decision by the Office of
Combination Products as an incremental, positive step forward for
our Vascular Wrap paclitaxel-eluting mesh program", said Rui
Avelar, MD, Chief Medical Officer at Angiotech. "With a 'device'
designation for this combination 'Graft and Vascular Wrap' product,
we expect to submit the PREVAIL data in accordance with our
timelines as outlined at our Vascular Program Update meeting in New
York last month." About Hemodialysis: The lives of patients with
end-stage renal disease are highly dependent on access to their
circulatory system in order to have their blood cleaned by
hemodialysis, a method of filtering out toxins in the blood by a
special machine called a dialyzer. Blood must be drawn from the
body, brought to the dialyzer, and then retuned. The blood is often
accessed from a special port which is a synthetic graft implanted
under the skin. Today there are an estimated 4.4 million people in
the U.S. with end-stage renal disease. Of these patients, 250,000
undergo hemodialysis treatment and roughly half of these patients
have synthetic grafts for hemodialysis access. About the Vascular
Wrap(TM) Paclitaxel-Eluting Mesh/Lifespan(R) Vascular Graft
Combination Product: Angiotech's Vascular Wrap(TM)
Paclitaxel-Eluting Mesh/Lifespan(R) Vascular Graft combination
product technology is designed to be used as a port for
hemodialysis access or as a bypass for a blocked artery. It is a
combination product consisting of both the Lifespan(R) Vascular
Graft and the Vascular Wrap(TM) Paclitaxel-Eluting Mesh. The
Lifespan(R) Vascular Graft product line component was acquired from
Edwards Lifesciences in November, 2005 and is meant to serve as one
of the key components for Angiotech's initiatives in the
interventional vascular field. The Vascular Wrap(TM) component is a
biodegradable mesh implant incorporating Angiotech's paclitaxel
technology in a novel biomaterial with the goal of mitigating scar
formation caused by graft implantation and thereby potentially
enhancing graft patency rates in AV-access patients as well as in
peripheral bypass procedures. About Combination Products: According
to the FDA, a "combination product" is defined as either 1) a
product comprised of two or more regulated components that are
physically, chemically or otherwise combined or mixed as a single
entity; 2) two or more separate products packaged together (e.g.,
drug and device products); or 3) provided separately but intended
for use together where both are required to achieve the intended
use, indication, or effect and where mutually conforming labeling
is needed. The assignment of the combination product to either a
"device" or "drug" designation is determined by what about the
combination product is considered to be the "primary mode of
action". Vancouver-based Angiotech Pharmaceuticals, Inc. is a
specialty pharmaceutical company pioneering the combination of
pharmaceutical compounds with medical devices and biomaterials to
both create novel solutions for poorly addressed disease states and
improve surgical outcomes. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please
visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. 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. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
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; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. FOR ADDITIONAL
INFORMATION: --------------------------- Analysts and Investors:
Todd Young, Vice President Investor Relations and Communications
Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933 Analysts:
Rui Avelar, Chief Medical Officer Angiotech Pharmaceuticals, Inc.
(604) 221-7676 ext 6996 Media: Colleen Beauregard Waggener Edstrom
Bioscience (503) 443-7863 Email: DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Analysts and Investors: Todd Young,
Vice President Investor Relations and Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7676 ext 6933; Analysts: Rui
Avelar, Chief Medical Officer, Angiotech Pharmaceuticals, Inc.,
(604) 221-7676 ext 6996; Media: Colleen Beauregard, Waggener
Edstrom Bioscience, (503) 443-7863, Email:
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