Singapore
and Tokyo, Japan - October 27, 2003
Biosensors and Terumo Sign Licensing Agreement
on First Drug-Eluting Stent to Undergo Full Clinical Trials
in Japan
Biosensors International, through its Netherlands-based
Occam International affiliate, and Terumo Corporation today
announced that both parties have entered into a definitive
licensing and supply agreement on a drug-eluting stent
developed for the Japan market, the second-largest in the
world in monetary terms. The device will be the first of
its kind to have the entire course of its clinical trials
conducted in Japan, involving Japanese patients and physicians.
Under terms of the agreement and subject to the successful
completion of clinical trials, the device will be distributed
exclusively in Japan by Terumo under Terumo's name and
incorporating Terumo's delivery catheter. Terumo will also
have non-exclusive distribution rights elsewhere in the
world outside of the U.S. Although specific monetary terms
were not disclosed, the agreement calls for Biosensors
to receive an up-front payment, additional payments tied
to clinical trial milestones and payments based on product
sales. Clinical trials of the device in Japan are targeted
to begin in 2004.
The drug-eluting stent is designed
to reverse the narrowing of coronary arteries that is
the hallmark of many cases of coronary artery disease.
Implanted in an artery following balloon angioplasty,
it uses the strength of its cylindrical metal mesh wall
to maintain restored blood flow. Following implantation,
it gradually releases ("elutes") into surrounding
tissues an anti-proliferative drug called Biolimus A-9.
Biolimus A-9 is formulated to inhibit excessive tissue
formation around the stent following implantation, a common
side effect called restenosis which often threatens to
reverse the clinical benefits of the angioplasty and stent
implantation procedures. Biolimus A-9 is proprietary to Biosensors and is being
evaluated in clinical trials of its MATRIXT stent in Europe, code-named the
STEALTH trial.
The stent structure used in the device
for Japan is derived from Biosensors' bare-metal S-Stent™,
which features a smaller, more flexible configuration
than most stents currently on the market or in clinical
trials, and which was specially designed for the smaller,
more tortuous blood vessels characteristic of Asian
physiques. S-Stent™ is an approved product widely
distributed in Asia.
"We are pleased to reach this agreement with Terumo, the
largest medical products company in Japan," commented Yoh-Chie
Lu, President and CEO of Biosensors International. "It
is gratifying to receive this validation of our product
development efforts by a company with Terumo's outstanding
leadership profile. The combination of Biosensors' innovations
and proprietary technologies with Terumo's brand reputation
and excellent stent and catheter technologies puts us on
a path to become one of the major suppliers of complete
DES systems in Japan and Asia in the next few years."
"We are delighted to enter into this partnership with
Biosensors International. Introduction of the new-generation
drug-eluting stent developed by Biosensors International
will strengthen our product portfolio in Europe, Asia and
Japan," commented Koji Nakao, Managing Executive Officer & Group
President of CV Systems / Interventional Systems of Terumo
Corporation.
The drug-eluting stent for Japan referred to in this press
release is an investigational device and is not approved
for sale by the Ministry of Health, Labor and Welfare in
Japan.
About Terumo
Terumo Corporation is a premier global medical company
with 2003 annual sales in excess of $1.7 billion. Terumo
Corporation develops, manufactures, and markets a wide
range of medical products including I.V. solutions, blood
bags, disposable medical devices, therapeutic catheters,
cardiovascular systems, peritoneal dialysis systems, diabetes
care systems, medical electronic products, etc. in more
than 150 countries.
For more information, please visit http://www.terumo.com/
Media Relations Contact:
Nori Takagi / Corp.orate Communication Department
Terumo Corporation, Tokyo, Japan
Tel: 81-3-3374-8283
Fax: 81-3-3374-8399
e-mail: ccd@terumo.co.jp.
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