Provalis PLC - Launching of Glycosal, etc.

RNS Number:2833H
Provalis PLC
15 March 2000

  Provalis Launches Innovative Diabetes Test Glycosal(TM)
     Major distribution alliances agreed with Bio-Rad
     Laboratories Inc and Drew Scientific Group plc
                            

Provalis plc today announces through its Diagnostics
Division, Provalis Diagnostics Ltd, the introduction of
an innovative new test, Glycosal(TM) that could significantly
improve the routine care of the diabetic patient.

Glycosal brings to the point of care the most widely
used test in diabetes management offering the prospect of
more immediate assessment of control and adjustment of
therapy.  The key facts are

-    Simple four minute test for glycated haemoglobin
     (HbA1c)
-    For use by diabetic clinics, G.P.s, nurses at the
     point of care'
-    Glycosal is certified by the European Reference
     Laboratory
-    Current global clinical laboratory market for HbA1c
     approximately $800m
-    Tighter control of diabetes is associated with the
     reduction of risk of debilitating long term complications
-    Launched at the British Diabetic Association's
     Annual Conference in Brighton
-    Strong international distribution alliances with Bio-
     Rad Laboratories Inc. and Drew Scientific Group plc
-    Additional UK distribution through Mediserve Ltd,
     and Provalis Healthcare Ltd

Commenting on this announcement John Curtis, Managing
Director of Provalis Diagnostics said: "The Provalis
Diagnostics team is justifiably proud to have
successfully developed such an innovative test with high
clinical relevance and with promise of improving the
quality of life for the diabetes patient.  Glycosal will
allow G.P.s and practice nurses to monitor control of
diabetic patients rapidly and accurately, and to adjust
their therapy accordingly. Glycosal(TM) has a performance
which sets new standards for tests carried out in the
doctors office and has been certified by the European
Reference Laboratory."

Commenting on the launch of Glycosal, Dr. Phil Gould,
Chief Executive of Provalis plc said: "At the launch of
Provalis we told our shareholders that we would start to
deliver new products and deals from our Diagnostics
division in the spring of 2000 following our successful
fundraising. I am delighted that Glycosal with such
remarkable performance starts to fulfil that promise. We,
together with Bio-Rad Laboratories and Drew Scientific
Group, believe that Glycosal(TM) delivers a product
performance, user friendliness and value for money
unmatched by any other system on the market available to
diabetologists, clinics, general practitioners and
pharmacies".

For further information:-

Dr Phil Gould, Provalis plc:               Tel: 01244 833463
Lisa Baderoon, Buchanans Communications:   Tel: 020 7466 5000


Notes to Editors

Glycosal(TM) Background

Provalis Diagnostics has succeeded in solving the problem
of making HbA1c testing widely available to the point of
care market. The company believes that this test will
significantly impact on the laboratory market for
diabetes testing with volumes currently running at around
100,000,000 tests per annum worldwide and with a market
value in excess of $800m. The test will shortly be
registered with FDA for 510k marketing approval in the
USA. The product will carry the C.E. mark supporting
sales throughout Europe.

Glycosal(TM) accurately measures HbA1c or glycated
haemoglobin  - the substance most commonly measured to
monitor the control or progress of patients suffering
from diabetes. Until now HbA1c measurement has only been
available from sophisticated laboratories using costly
equipment and qualified staff skilled at these complex
laboratory based techniques. The new Provalis break
through product, Glycosal, now allows this important test
to be carried out by G.P.s and nurses in a simple four-
minute compact format.

To emphasise the opportunity that this new test
represents Provalis has been able to attract two of the
international market leaders in laboratory based HbA1c
testing, Bio- Rad Laboratories Inc. from the USA and Drew
Scientific Group plc from the UK to be semi-exclusive
distributors for marketing the test throughout the world.

Bio-Rad Laboratories Inc., currently the world's market
leader for HbA1c laboratory based methods, will market
the test under the Bio-Rad name MICROMATII.  Drew
Scientific Group is the UK's largest researcher and
manufacturer of equipment used by clinical laboratories
for HbA1c testing; it will market the test as DS1
GLYCOMAT. Drew has world wide sales, marketing and
distribution through a series of International partners
across all the major healthcare markets.  Both companies
see Glycosal as an important addition to their current
product ranges.

The test will also be sold in the UK through Mediserve
Ltd., an authorised distributor and a specialist in
promotion to diabetic clinics. In addition, Provalis has
reserved its position to appoint further partners in the
through pharmacy testing' and e-commerce marketplaces.

Diabetes and the role of HbA1C testing

The prevalence of diabetes is currently 3-5% of the
world's population. A similar number are thought to be
undiagnosed diabetics who would greatly benefit from
diagnosis. The disease manifests itself as an inability
for the patient to control the amount of glucose in the
blood. In normal individuals blood glucose is normally
held within quite narrow limits.  If uncontrolled blood
glucose levels rise beyond this range it results in acute
symptoms and over time is associated with the development
of many long-term complications such as increased heart
disease, kidney disease, and loss of visual acuity and
blindness.

Until now the only point of care test available to
monitor blood glucose levels in diabetics at the point of
care is the glucose strip available to healthcare
professionals and sold widely through pharmacies
throughout the world. In 1999 this market was worth some
$2.5Bn worldwide.

The drawback of glucose testing is that the level of
glucose in patients fluctuates widely over the day
depending on a number of factors such as when and what
was last eaten. This variation means that it is difficult
for the doctor to monitor meaningfully the real ongoing
severity of the patient's diabetes.

Blood glucose reacts with haemoglobin in the red blood
cells to form the relatively stable complex HbA1c. This
interaction occurs slowly, and therefore, for HbA1c to be
increased, the level of glucose in the blood must stay
above normal for a considerable period of time. Because
this measure is then related to the half-life of the red
blood cells, HbA1c reflects tightness of glucose control
over the preceding 3 months. It has therefore become the
yardstick by which glucose control can be reliably
monitored avoiding the misleading fluctuations of blood
glucose itself and by which therapy can be more reliably
selected and adjusted.

All diabetics would potentially benefit from an easily
available accurate point of care test for HbA1c.
Although complex tests requiring expensive equipment are
well established in the clinical laboratory a simple
inexpensive test such as Glycosal will allow G.P.s and
diabetic clinics to measure HbA1c rapidly and amend
therapy with confidence whilst the diabetics are still in
the surgery.  Currently the patient has to return a week
later when the laboratory test results become available
to the clinician or specialist.

HBA1c Test Background and Impact For Long-term Diabetes
Control and Complications

HbA1c became the test of choice for maintenance of
patients with diabetes after two extensive studies
confirmed its potential. The Diabetic Control and
Complications Trial in the USA followed the HbA1c levels
and clinical complications of over 1,400 diabetics in the
USA over a ten-year period and linked the absolute level
of HbA1c to the severity of the complications experienced
by the patients. The study showed that the higher the
level of HbA1c the greater the clinical complications.
The UK Prospective Diabetes Study followed 5,000 patients
over a 20 year period and concluded that for every 1%
drop in HbA1c level there was:

-    A reduction by 25% in diabetes related deaths
-    An overall reduction of 25% in diabetes related
     complications
-    A 35% reduction in vascular side effects of the
     disease
-    An 18% reduction in diabetes related heart attacks


Provalis plc

Provalis (www.provalis.com) is an integrated healthcare
provider in the areas of Medical Diagnostics,
specialising in simple diagnostics for use at the point
of care, ethical healthcare sales and distribution with
market leading products from Dr Falk Pharma GmbH and
other world leading pharmaceutical companies and a
therapeutic R&D division specialising in the research and
development of therapeutic vaccines. Provalis is located
in Deeside, North Wales, UK and is listed in London
(LSE.PRO), and NASDAQ (PVLS).


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.

References:

Comparison of Glycosal(TM), a rapid point of care test, with
laboratory methods for the measurement of HbA1c.
Stevenson A. Cresswell M. Poster; American Diabetes
Association Annual Meeting, San Diego 1999

Glycosal, a rapid point of care test for the measurement
of HbA1c. Stephenson A., Cresswell ., Poster, European
Association for the study of Diabetes Annual Meeting,
Milan 1999.

Glycosal:The first Rapid Point of Care Test for the
Determination of Hemoglobin A1c in Patients with
Diabetes. Stephenson A. Diabetes Technology and Therapy.
Volume 1, Number 4, 1999.

The Diabetes Control and Complications Trial Research
Group: The effect of intensive treatment of diabetes on
the development and progression of long-term
complications in insulin-dependant diabetes mellitus. Eng
J Med; 329,977-986

UK Prospective Diabetes Study Group: Intensive blood
glucose control with sulphonylureas or insulin compared
with conventional treatment and risk of complications in
patients with type 2 diabetes. 1998 Lancet; 352, 837-853

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