NORWOOD ABBEY LIMITED 2003-01-13 ASX-SIGNAL-G
HOMEX - Melbourne
+++++++++++++++++++++++++
Norwood Abbey Ltd (ASX: NAL) today announced that the US Food and
Drug Administration (FDA) has granted 510(k) marketing approval for
the Company's Laser-Assisted Drug Delivery (LAD) device for "ablation
of the outer layer of the skin prior to the application of OTC
topical 4% lidocaine cream, for local dermal anaesthesia". This
device, which is comprised of a laser device together with single-use
disposable tips, is designed to painlessly and temporarily alter the
stratum corneum, or outer layer of skin, allowing for more
efficacious delivery of topically applied drugs.
The Company believes that this proprietary technology represents a
breakthrough in transdermal drug delivery, and is very pleased to now
be in the position to have achieved this important milestone related
to release of the product in the US market.
"The approval represents a major milestone to achieving the Company's
goal of generating profits from the LAD project and becoming cash
flow positive", commented Peter Hansen, Executive Chairman of Norwood
Abbey. "Our research indicates that in addition to local
anaesthetics, there are a large number of additional drugs that
potentially can be delivered more effectively when used with the
LAD."
Norwood's North American marketing partner for the LAD, Ferndale
Laboratories Inc, will package Norwood disposable LAD tips with its
over-the-counter topical anaesthetic, Ela-Max(R).
The primary market for the product is expected to be patients
undergoing various procedures requiring needle-sticks, including
injections, intra-venous insertions and blood donations. Prime
initial target customers include clinicians and health care
professionals in the fields of:
* Dermatology/Plastic Surgery (Approximately 15,000 in USA)
* Oncology (Approximately 2000 in USA)
* Paediatrics (Approximately 11,000 in USA)
* Blood Donations
While the strategy with respect to the laser project has always been
to primarily concentrate on the receipt of an annuity or continuing
revenue stream from the sale of single use disposable tips, the
Company also expects to generate profits from the sale of the device.
Under the commercial arrangements that have been negotiated with
Ferndale Laboratories Inc in Detroit, Norwood Abbey, through a
network of direct sales representatives, medical wholesalers and
distributors, will sell disposable tips and drug in a single package
throughout North America. Market research has indicated that devices
are likely to be used, on average, 1,000 times per annum. Norwood
expects to net approx AUD$2.00 per disposable/procedure and
approximately AUD$2,000 per device per annum.
The Company currently expects to have sold or placed 10,000 devices
by the end of calendar 2005. This would generate - on an ongoing
basis - approximately AUD$20 million per annum in gross profit or
approximately 15 cents (pre-tax) for each Norwood share on issue.
In order to maximize market penetration, the Company has negotiated
an arrangement with Ferndale whereby in a situation where a potential
customer is not able to 'fund' the capital cost of the device,
Norwood - together with Ferndale - will be able to place a device
with a customer in return for the ongoing purchase of a minimum
number of 'procedures' ie drugs and disposable tips.
Norwood has appointed a Vice-President for the laser project in North
America, Mark McLoughlin, a distinguished healthcare industry
specialist. Mr McLoughlin will take the project to the next step of
manufacturing, market development, sales, marketing and distribution.
The Company will also seek to pursue further commercial applications,
such as the possible delivery of vaccines, anti-inflammatories and
other drugs.
To keep costs low, both the manufacture of the LAD and disposable
tips is being outsourced to international groups with experience in
manufacturing medical devices. This will of course, also reduce
Norwood's need for working capital and reduce the cost of the LAD and
the disposable tips.
Besides the significant initial market for its use in North America,
Norwood has also commenced discussions with respect to targeting the
European and Australasian markets. Limited sales have already been
made in Australasia for specific applications and the project is
expected to progressively generate substantial revenue from Asia.
As a result of positive feedback from the USA market, work is now
under way on a second-generation laser device for local anaesthetics
that would cover a wider area of the skin.
Norwood Abbey Ltd is a drug delivery and immunology company with
three proprietary delivery platforms in various stages of
commercialisation and development. Its delivery technologies include
laser-assisted delivery, micro-needle arrays and pressure wave
technology for the transfer of both drugs and genetic material.
In addition, the Company holds patent applications for the use of
GnRH analogue drugs in the re-growth of the Thymus gland and
production of new T-cells. GnRH drugs are already approved for the
treatment of prostate and breast cancer and have been available on
the market for many years.
For further information about Norwood, visit the Company's web site
at www.norwoodabbey.com
COMPANY CONTACTS: US INVESTOR CONTACTS:
Peter Hansen Lippert/Heilshorn & Associates Inc
EXECUTIVE CHAIRMAN Kim Sutton Golodetz ([email protected])
+613 9782 7333 212 838 377
Bernie Romanin Bruce Voss ([email protected])
DIRECTOR OF MARKETING 310 691 7100
+613 9782 7333 www.lhai.com
[email protected]
www.norwoodabbey.com
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