Angiotech to market Vascular Wrap(TM)/ePTFE graft combination product through its own European sales and distribution networks
10 Mai 2007 - 3:00PM
PR Newswire (US)
VANCOUVER, May 10 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced that it has amended its agreement with Edwards
Lifesciences Corporation ("Edwards"), regarding the distribution of
Angiotech's Vascular Wrap(TM) paclitaxel-eluting mesh/ePTFE graft
combination product. Angiotech now has the exclusive rights to
distribute the Vascular Wrap(TM)/ePTFE graft combination product
through its own sales force and distribution network in Europe.
Edwards still retains the same marketing and distribution rights
with respect to the stand-alone Lifespan(R) vascular graft product
line as outlined in the original agreement. "First of all, I want
to thank Edwards for agreeing to revise the terms of our original
agreement. At the time of the initial agreement, we lacked the
commercial infrastructure to distribute products ourselves, but
since then we have grown significantly and have added the
capability to access the EU market directly through our own sales
and distribution network, said Dr. William Hunter, President and
CEO of Angiotech. "Based on the recent positive results from our
two-year European study, we believe that the Vascular Wrap product
will be a key catalyst for Angiotech going forward, and we felt it
was imperative that we establish our presence and brand in this
market right from the initial launch date," added Dr. Hunter. "We
believe the Vascular Wrap product represents a completely new
therapeutic option for vascular surgery procedures that has
considerable market potential. Launching the product under our own
name and through our own commercial group is an important step for
us in building this significant vascular franchise at Angiotech,"
said Dr. Santi Corsaro, VP Sales and Marketing (OUS) for Angiotech.
"By becoming the exclusive distributor of our Vascular Wrap/ePTFE
graft combination product in Europe, we can take full control of
the European marketing strategy for this key product, as we are
rapidly building our own sales and distribution network," added Dr.
Santi Corsaro. In December 2005, Angiotech acquired the Lifespan(R)
ePTFE vascular graft business from Edwards. This transaction
included a distribution agreement whereby Edwards was given the
rights to distribute the stand-alone Lifespan(R) ePTFE vascular
graft product line in Europe and the United States, as well as
Angiotech's Vascular Wrap(TM)/ePTFE graft combination product in
Europe. Subsequent to this transaction, Angiotech acquired its own
sales force and distribution infrastructure in March 2006 through
the acquisition of American Medical Instrument Holdings, Inc.
(AMI). As a result, Edwards has agreed to amend the agreement and
return to Angiotech the distribution rights of the Vascular
Wrap(TM)/ePTFE graft combination product in Europe. Upon receipt of
a CE Mark, Angiotech will commence commercialization - including
obtaining any relevant reimbursement approvals - of its Vascular
Wrap(TM) product in the EU and certain other countries outside of
the United States. About the Vascular Wrap(TM) Paclitaxel-Eluting
Mesh/ePTFE Graft Combination Product Angiotech's Vascular Wrap(TM)
paclitaxel-eluting mesh/ePTFE graft combination product technology
is designed to and in development for use in hemodialysis access
and peripheral arterial bypass surgery. It is a combination product
consisting of both the ePTFE graft and the Vascular Wrap(TM)
paclitaxel-eluting mesh. The Vascular Wrap(TM) component is a
biodegradable mesh implant incorporating Angiotech's paclitaxel
technology in a novel biomaterial with the goal of enhancing graft
patency rates in AV-access patients as well as in peripheral bypass
procedures. About the Current Pivotal Study In March 2007,
Angiotech launched a U.S. multi-center study, which is 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 hemodialysis vascular (AV) access. The pivotal trial
is a randomized, placebo-controlled, multi-center, two-arm study.
The primary objective of the study is to demonstrate that the
patency of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh and the
ePTFE graft is superior to the patency of the ePTFE graft alone
within one year following vascular access surgery. Subjects will
also be followed over a four-year period to confirm the long-term
safety of this product candidate although the Company anticipates
filing for U.S. regulatory approval after completion of the primary
one year follow up period. 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 Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. Note on Forward Looking Statements:
Statements contained in this press release or in our other written
or oral public communications that are not based on historical or
current fact, including without limitation statements containing
the words "believes," "may," "plans," "will," "estimate,"
"continue," "anticipates," "intends," "expects", "hopes" 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 in this release
include but are not limited to the statements regarding; financial
benefits to Angiotech that could potentially be realized in
Angiotech's vascular business, the ability of Angiotech to
successfully develop and commercialize the Vascular Wrap
paclitaxel-eluting mesh, the ability of Angiotech to find other
potential uses for the product, that a substantial market exists
for the product, and the successful initiation, completion and
outcome of the clinical trials referred to in the press release.
Such forward-looking statements are based on assumptions that
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. The assumptions include; that Angiotech will have the
ability to market and sell the product itself, that the market
potential for the product is significant, that Angiotech will be
able to obtain regulatory approval to develop and commercialize the
products referred to in the press release and that the outcomes of
the clinical trials referred to in the press release will be
positive. The risks and uncertainties include, among others; the
timing of, and safety and efficacy results from, the clinical
trials referred to in the press release, decisions made by
Angiotech based on these results, the ability to obtain regulatory
approval to develop and commercialize new products, the ability to
manufacture sufficient quantities of product for development and
commercialization activities and to do so in a timely and cost
efficient manner, the competitive environment for such products,
the ability to persuade physicians to use the products, the
availability of resources and funding, the potential size of the
market for the product, and the risks and uncertainties associated
with the business and described in Angiotech'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. 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 prospectus to reflect future results, events or
developments. (R) Lifespan is registered trademark of Edwards
Lifesciences Corporation (TM) Vascular Wrap is a trademark of
Angiotech Pharmaceuticals, Inc. CONTACT: Janet Craig, VP, Investor
Relations & Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-6933, ; Jodi Regts, Manager,
Investor Relations & Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-7930, DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Janet Craig, VP, Investor Relations & Corporate
Communications, Angiotech Pharmaceuticals, Inc., (604) 221-6933, ;
Jodi Regts, Manager, Investor Relations & Communications,
Angiotech Pharmaceuticals, Inc., (604) 221-7930,
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