Regulatory Approval
23 Août 2000 - 9:00AM
UK Regulatory
RNS Number:8262P
Provalis PLC
23 August 2000
APPROVAL OF GLYCOSAL IN THE USA
AND COMMERCIAL UPDATE
Provalis Diagnostics, the medical diagnostics division of
Provalis plc, has today received 510K regulatory approval
for its innovative 'point of care' diabetes-monitoring
product, Glycosal in the USA. 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.
The product is approved for use by doctors and healthcare
professionals and the Company will immediately apply for
CLIA waiver, which would allow its use by a broader range
of healthcare support staff.
The product will be sold through our distributors Bio-Rad
Laboratories Inc as the Micromat II and Drew Scientific
Group plc and its distributors as the DS1 Glycomat.
Stock build and an increase in tooling capacity to
support this launch are already underway.
Provalis has already launched the product in the UK
through an association with Mediserve Ltd and the product
is currently available in over 20 markets in Europe,
South American and the Far East through our main
distributors. A registration is in preparation for Japan
where the product will be sold through Bio-Rad
Laboratories and a domestic Japanese distributor.
John Curtis, Managing Director of Provalis Diagnostics
commenting on the approval said, 'Provalis Diagnostics is
justifiably proud to achieve regulatory approval of
Glycosal in the USA market. Our distribution partners,
Bio-Rad and Drew, can now begin selling the product in
the world's largest single healthcare market. Glycosal
now has strong marketing partners and global regulatory
approval excluding Japan. It provides user simplicity
and a price profile to make it a significant world
product, both commercially and for the assistance it can
bring to those suffering from diabetes. By using this
simple test the doctor now knows how well the patient's
diabetes is being controlled and also is aware that every
1% reduction in HbA1c level reduces the long term side
effects due to the disease by 25%.'
The market response to Glycosal has been extremely
encouraging; we already have orders to place greater than
1000 Glycosal instruments in the field, excluding the
USA, by December 2000 and the supply of tests is also
underway.
Phil Gould, Chief Executive of Provalis added, ' This is
excellent news for the Company and Glycosal is now our
second 'point of care' diagnostic on the US market. With
the approval and launch of Glycosal in the USA, it's
European Reference Laboratory Certification to support
sales and with strong global distribution partners, we
are well placed to have a significant revenue generating
medical diagnostic product on world markets.
We have met another important commitment within the
progress of our plan to build a successful and profitable
integrated healthcare Company. With the expected sales
of Glycosal this will support the growing revenue and
profit base of the Company.'
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(TM) and
Osteosal(TM), 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(TM)
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
100,000,000 laboratory test market for HbA1c by bringing
the test to the 'point of care'.
* 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
* Current global clinical laboratory market for
glycated haemoglobin approximately US$800 million
* 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.
Drew Scientific Group plc
Drew Scientific Group plc (www.drew-scientific.com)
designs and manufactures analytical instrumentation and
related consumables based on micro-column liquid
chromatography. The company has its headquarters and
manufacturing facilities in the United Kingdom and sells
its products throughout the world.
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