Re Marketing Approval
30 Août 2000 - 9:00AM
UK Regulatory
RNS Number:1059Q
Provalis PLC
30 August 2000
Provalis plc
APPROVAL OF GLYCOSAL IN JAPAN
Following the announcement of 23rd August 2000 that
Provalis Diagnostics, the medical diagnostics division of
Provalis plc, received USA regulatory approval for its
innovative point of care diabetes-monitoring product,
Glycosal, the Company is delighted to announce that it
has now received marketing approval from Japan. The
product will be sold in Japan through our distributor Bio-
Rad Laboratories Inc as the Micromat II.
The product measures glycated haemoglobin in a single 4
minute test carried out in the doctor s office.
Glycosal measures the diabetic s average level of
glucose over the last three months by measuring a
specific fraction of the patients haemoglobin called
HbA1c. The product is used to help monitor the severity
of, and the effectiveness of long-term therapy for,
diabetes.
John Curtis, Managing Director of Provalis Diagnostics
commenting on the approval said, "I have to thank our
distributor Bio-Rad for assisting us in this approval.
Their Japanese subsidiary achieved this in record time
and considerably ahead of schedule. The Japanese market
for Glycosal is considerable and we are delighted that
we can now begin sales of the product.
Phil Gould, Chief Executive of Provalis added, "Coming on
the back of last weeks news about the USA registration
this is excellent further news for the Company. We now
have global approval for Glycosal within 6 months from
initial launch - we believe this must be a record for any
British Healthcare Company. I must also congratulate our
partners Bio-Rad who have provided such excellent support
to us. We are now looking forward to a prosperous
relationship as the product begins to make sales in both
the USA and Japan in addition to the markets in which the
product is already sold.
Provalis Internet Website ; http://www.provalis.com
"Safe Harbor" Statement under the US Private Securities
Litigation Reform Act of 1995: Some or all of the
statements in this document that relate to future plans,
expectations, events, performances and the like are
forward looking statements as defined in the US Private
Securities Litigation Reform Act of 1995. Actual results
of events could differ materially from those described in
the forward looking statements due to a variety of
factors, including those set forth in Provalis plc s
filings with the US Securities and Exchange Commission.
For further information:-
John Curtis, Managing Director, Provalis Diagnostics Ltd
Tel: 01244 833542
Dr Phil Gould, Chief Executive Officer, Provalis plc
Tel: 01244 833463
Lisa Baderoon, Buchanan Communications
Tel: 020 7466 5000
Notes to Editors
Provalis PLC (LSE.PRO and NASDAQ.PVLS) is an integrated
healthcare company with three separate divisions focused
on the supply and sale of prescription medicines, the
development and global sale of medical diagnostics, and
the development of new therapeutic products, such as
vaccines to combat infectious diseases.
The three divisions are:-
Healthcare - This Division carries on the supply,
sale and marketing of branded, third party,
prescription medicines in the UK to GP s and
Hospitals through its own regionally managed sales
force. Its current product range includes products
for use in the medical areas of gastroenterology,
osteoporosis, migraine and dermatology.
Medical Diagnostics - This Division carries on the
development and sale of medical diagnostic products
for sale to global markets through a number of
distributors. The Division has recently launched
the innovative diagnostic products Glycosal and
Osteosal, in the areas of diabetes and osteoporosis
respectively, and has a worldwide franchise in
medical diagnostic products for infectious diseases.
Therapeutic Research & Development - This Division
carries on the development of new therapeutic
products, including vaccine candidates for
infectious diseases. A number of vaccine candidates
are at the pre-clinical stage.
Glycosal
Glycosal brings to the "point-of-care" the most widely
used laboratory test in diabetes management offering the
prospect of lower cost, more immediate assessment of
control and adjustment of therapy. The key facts are:
* Glycosal will immediately compete in the current
100m laboratory test market for HbA1c by bringing the
test to the "point of care".
* HbA1c market currently valued world-wide as $800m to
$1bn
* Glycosal is a simple four minute test for glycated
haemoglobin
* For use by diabetic clinics, G.P.s and nurses at the
"point-of-care"
* Glycosal(TM) is certified by the European Reference
Laboratory
* Tighter control of diabetes is associated with the
reduction of risk of debilitating long term complications
* Diabetic complications include blindness,
amputation, cardio vascular disease and increased risk of
stroke
* These complications reduce the average life
expectancy of the diabetic by 15 years. Each 1% reduction
in HbA1c level reduces this risk by 25%.
Bio-Rad Laboratories Inc.
Bio-Rad Laboratories Inc. (www.bio-rad.com) is a
multinational manufacturer and distributor of life
science research products, clinical diagnostics and
analytical instrumentation with a network of 25 wholly
owned subsidiaries serving over 70 countries. The company
is based in Hercules California and employs over 2500
people worldwide. In October 1999 Bio-Rad acquired
Pasteur Sanofi Diagnostics whose sales in 1998 were
approximately $210 million. Bio-Rad s sales in the year
ending Dec. 31st 1999 were $549.5 million. Sales for the
combined company are estimated to be $722 million per
annum.
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