
Provalis PLC
17 June 2004
For Immediate Release 17th June 2004
Provalis Files G5 Diabetes Test with FDA and builds USA Sales Team
Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce that, on schedule, it has filed
the USA regulatory submission with the FDA for its G5 diabetes glycated
haemoglobin test.
Regulatory clearances are being sought in the USA for 510K and prescription home
use marketing approvals, which additionally confers CLIA waiver. These allow
the Company to fully exploit the sales potential of G5 into all physicians'
offices and also to be available eventually to diabetics for use at home.
In further preparation for the launch of the product in the USA, Provalis has
now appointed its three vice-presidents of sales to cover the central, west
coast and east coast regions. They, together with Bert Valada the General
Manager of Provalis Diagnostics (USA), have collectively over 100 years of
diagnostics sales experience in the USA and are now building the network of
national sub-distributors ready for product launch in the autumn (fall) of this
year.
Phil Gould, Chief Executive Officer of Provalis said 'We are delighted with the
high quality of the clinical data we have generated with G5 and that we have now
filed on schedule the USA regulatory submission with the FDA. With an
experienced sales team now recruited in the USA, we look forward to a successful
product launch in the autumn of this year'.
END
Provalis' Internet Website ;
http://www.provalis.com
Comment - Provalis has a market cap of 17m. At one time, when called Cortecs, the company was a medium sized pharma. During the tech bubble it lost its way and eventually had to re-invent itself. It re-directed its efforts to the diagnostic side of the market, finally producing Glycosal, a physician's office blood-testing equipment for diabetics. Another rights' issue later and it has finally filed for G5 approval (allowing for a similar test for home use). It has decided to create its own market distribution network - very risky. It is against some much larger competitors such as Axis-Shield (Afinion) which are closer to marketing their own versions of G5 - even offering multi-platform testing - but in less than 90 days Pro will also be selling its G5 product. Diabetes is a huge market, as we all know from reading about obesity etc. Pro only has to catch a small slice of this market to increase its market cap many times over. A very risky punt but it could be rewarding if you get in at the bottom. 7.125p mid-price at the time of writing.