NEWS RELEASE
Singapore-listed Biosensors Obtains CE Mark Approval
for Axxion Drug-Eluting Stent
Singapore, 12 July 2005: SGX Main Board-listed Biosensors International Group, Ltd.
(“Biosensors,” Bloomberg: BIG SP), announced that its Netherlands-based subsidiary,
Occam International B.V. has received Conformité Européene (“CE”) Mark approval for
the Group’s first drug eluting stent (DES), Axxion.
“We had expected to receive the CE approval for Axxion in the second half of 2005. We
are elated to receive this approval now, barely one month into our expected time period,”
said Mr. Yoh-Chie Lu, CEO and Chairman of Biosensors. The CE Mark is an
international symbol for medical devices that adhere to strict quality assurance standards
issued by the European Union.
“In anticipation of CE Mark approval, we have already ramped up our manufacturing and
marketing preparedness. We are operationally ready to launch Axxion in selected
markets, which is an essential part of our long-term strategy to have the
commercialization of our own DES products drive the Group’s future revenues,” added
Mr. Steve Thomson, Chief Operating Officer.
Products that have received the CE Mark are allowed to be sold in the European Union.
Other foreign regulatory agencies, for example, those in Asia, have adopted an approval
process that is a combination of the US or European review process. In most cases, the
regulatory process in these countries is less difficult, although not avoided, by presenting
evidence of the EU approval.
Biosensors’ Axxion DES is a polymer-free system which incorporates its Calix stent
delivery system and the commercially available drug, paclitaxel. The drug is directly
coated on the stent over a layer of glycocalix, a substrate designed to improve
biocompatibility of the metal stent surface after the drug is released. This technology is
licensed exclusively by Occam from a privately-held company in Germany that is a
leading designer and manufacturer of ultra-thin coatings that set unsurpassed standards
of efficiency, hemocompatibility and biocompatibility.
“The “polymer-free” approach potentially can reduce concerns about the long term
effects of polymer coatings used in competitors’ products,” stated Mr. Lu.
Biosensors expects sales of Axxion to contribute to the Group’s revenue for the current
financial year ending 31 March 2006 prior to receiving regulatory approval of its flagship
DES system, BioMatrixTM which it had filed for CE Mark in April 2005.
The BioMatrix™ DES system incorporates the Group’s proprietary anti-restenotic drug,
Biolimus A9™, bioresorbable polymer, S-Stent™ and stent delivery catheter, all of which
have been developed in-house. Biosensors expects to receive CE Mark approval for its
BioMatrix™ in the first half of calendar 2006.
### end of release ###
Media Contact
WeR1 Consultants Pte Ltd
Ms Mona Leong, Senior Consultant
Tel
: (65) 6737 4844
Email
: monaleong@wer1.net
Biosensors International Group
Ms Tina Lim, Executive, Corporate Communications
Tel
: (65) 6213 5712
Email
: tina@biosensors.com.sg
For investor related enquiries, please write to ir@biosensors.com.sg
About Biosensors International Group, Ltd.
Biosensors develops, manufactures and markets innovative medical devices used in interventional cardiology and critical
care procedures. Biosensors believes that it is well-positioned to emerge as a leader in drug-eluting stents, an evolving
therapy that is rapidly gaining market share from traditional therapies such as bare-metal stenting and open heart surgery.
Biosensors has internally developed technology to address each component of a drug-eluting stent system, including a
stent, a stent delivery catheter, a bioresorbable polymer and a proprietary anti-restenotic drug. It is pursuing two drugeluting stent programs independently (BioMatrix™ and Axxion), and has licensed aspect of its drug-eluting stent technology
to four licensees.
Forward Looking Statements
Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation
Reform Act of 1995. Forward-looking statements generally can be identified by the use of forward-looking terminology, such
as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “project” or “continue” or the negative thereof or other
similar words. All forward-looking statements involve risks and uncertainties, including, but not limited to, customer
acceptance and market share gains, competition from companies that have greater financial resources; introduction of new
products into the marketplace by competitors; successful product development; dependence on significant customers; the
ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual
results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking
statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new,
changing or unanticipated events or circumstances.
Sponsorship statement: Citigroup Global Markets Singapore Pte. Ltd. was the Sole Global Co-ordinator and Sole
Bookrunner, Joint Lead Manager and Underwriter of the offering (the “Offering”) in respect of 185,434,000 shares of the
Company pursuant to the prospectus issued by the Company dated 22 April 2005. The Joint Lead Manager and Underwriter
of the Offering was UBS AG, acting through its business group UBS Investment Bank. The Joint Lead Manager, Local
Coordinator and Underwriter for the Offering was UOB Asia Limited.