Angiotech and Rex Medical announce exclusive licensing and distribution agreement for the "Option(TM)" inferior vena cava filter
13 März 2008 - 9:34PM
PR Newswire (US)
VANCOUVER, March 13 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) announced
today that it has entered into a definitive licensing agreement
with privately held Rex Medical, LP ("Rex Medical") for exclusive
worldwide rights to market and distribute the Option(TM) inferior
vena cava (IVC) filter, a medical device that is implanted into the
body's inferior vena cava to prevent pulmonary embolism (PE).
According to industry research, the U.S. market for IVC filters in
2007 was approximately $200 million with retrievable filters
accounting for approximately two-thirds of this market. The
Option(TM) IVC filter, developed by Rex Medical, is an IVC filter
specifically designed for long-term retrieval post device
implantation and is expected to be approved for both permanent and
retrievable indications. Angiotech and Rex Medical will be
exhibiting at the 33rd Annual Meeting of the Society of
Interventional Radiology (SIR) to be held in Washington, DC from
March 15-18, 2008. "With product offerings such as the Option(TM)
IVC filter and our EnSnare(TM) retrieval device, we are continuing
our commitment to offer industry-leading technologies to service
the needs of our interventional and endovascular call points. We
believe that the Option(TM) IVC filter is a cornerstone technology
for our Interventional business and a 'best-in-class' product that
will be significantly differentiated in the marketplace," said Dr.
William Hunter, President and CEO of Angiotech. "We are pleased to
have entered into this commercial partnership with Angiotech for
the Option(TM) IVC filter in such a critical market for the
interventional community. We believe that the Option(TM) IVC filter
is a superior IVC filter and will significantly improve the
clinical management of pulmonary emboli in patients. Clinical data
from our international clinical study has shown that the Option(TM)
IVC filter can be successfully retrieved in patients for longer
than one year. The development of the Option(TM) filter further
exemplifies Rex Medical's commitment to the delivery of
ground-breaking medical devices for the interventional community,"
said Dr. James F. McGuckin, Co-Founder of Rex Medical. Rex Medical
expects to complete enrolment of its U.S. clinical study for the
Option(TM) IVC filter in the treatment of PE by the end of Q2 2008.
Rex Medical anticipates that the filing for 510(k) approval with
the FDA for the Option(TM) IVC filter will be completed in the near
term. Rex Medical has filed for the CE Mark for the Option(TM) IVC
filter and is awaiting approval from the European regulatory
bodies. Pending regulatory approval, it is expected that the
Option(TM) IVC Filter will be available for commercial sale through
Angiotech's Interventional sales force in the U.S. and in the EU by
the end of 2008. "As the Lead Investigator on the Option(TM) IVC
Filter clinical trial, I am impressed with the low profile (6Fr OD)
delivery system and novel nitinol design. Results to date suggest
that it prevents PE as well as any commercially available filter.
And despite its remarkable stability, the Option(TM) has been
safely and successfully retrieved at long intervals - up to 175
days in the U.S. IDE," said Dr. Matthew S. Johnson, MD, Professor
of Radiology and Surgery at Indiana University School of
Medicine/Chief, Vascular and Interventional Radiology, Clarion
Health Partners. Financial terms of the agreement were not
disclosed. About the Option(TM) Inferior Vena Cava Filter The
nitinol, Option(TM) IVC Filter, with a low profile 5Fr (6Fr O.D.)
delivery system, is designed to be implanted into the inferior vena
cava of patients to prevent recurrent PE. The filter is designed
with symmetric flared struts to direct clot volume into the center
of the vessel for maximum dissolution and preservation of blood
flow allowing for capture of clinically significant clot and
protection against PE. Designed as both a permanent or retrievable
IVC filter, the self-centering filter promotes optimal positioning
and stability within the inferior vena cava. Its intuitive,
easy-to-use design makes the Option(TM) IVC filters' deployment and
retrieval both safe and effective. About Pulmonary Embolism (PE) PE
is an extremely common and highly lethal condition that is a
leading cause of death in all age groups. PE is the sudden blocking
of an artery of the lung (pulmonary artery) by a collection of
solid material brought through the bloodstream (embolus) - usually
a blood clot (thrombus) or rarely other foreign material. PE occurs
when these clots break loose and embolize to block pulmonary blood
vessels in the lungs. PE affects an estimated 600,000 to 1,000,000
people in the US, and its incidence is increasing annually due
mainly to the aging population. According to clinical research, if
left untreated, PE has a mortality rate of 30% and is a leading
cause of in-patient deaths in U.S. hospitals. Emboli dislodgement
can be caused by peripheral vascular disease (PVD), severe deep
vein thrombosis (DVT), trauma and, prolonged immobilization often
following major surgical procedures. About Angiotech Angiotech
Pharmaceuticals, Inc. is a global specialty pharmaceutical and
medical device company with over 1,600 dedicated employees in 18
different countries. 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
http://www.angiotech.com/. About Rex Medical, LP Rex Medical, LP,
based in Conshohocken, PA, is a privately held medical device
company specializing in the development, manufacturing and
marketing of minimally invasive medical devices targeted towards
the cardiovascular, venous access, endosurgery and oncology
markets. 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. ("AMI");
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. (TM) Option is a trademark of Rex Medical, LP, used
under license by Angiotech. EnSnare is a trademark of Angiotech.
CONTACT: Angiotech Contact: Deirdre Neary, Angiotech
Pharmaceuticals, Inc., (604) 222-7056, DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Angiotech Contact: Deirdre Neary,
Angiotech Pharmaceuticals, Inc., (604) 222-7056,
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