Forum Archive Index - March 2000

["David Reid" <aspex@ix.net.nz>]

This share (also on ASX as PVL) fell after US hype back to 35p (UK)

News that supports the pharmaceuticals in UK like Provalis

example today:

 

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