pachandl
- 23 Jun 2004 16:20

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.
pachandl
- 01 Jul 2004 11:22
- 2 of 75
Provalis PLC
1 July 2004
For Immediate Release 1st July 2004
Provalis plc
Provalis signs Vaccine Option Agreement with Chiron Vaccines
Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical Diagnostics and
Pharmaceuticals Group, today announces that it has signed an option agreement
with Chiron Vaccines. Under the terms of the agreement:
Chiron Vaccines is granted an initial 12 month, exclusive
option (extendable by a further 12 months on payment of a fee) to evaluate
Provalis' protein based vaccine candidates to prevent Group B Streptococcus
infection;
Chiron Vaccines has paid an initial option fee to Provalis
and will pay all costs connected with the patents underpinning these vaccine
candidates; and
Chiron Vaccines has the right to enter into an exclusive
licence for, or to acquire, these vaccine candidates, in both cases on
pre-determined terms (which include the quantum of staged milestone payments and
royalty rates for the licence).
Commenting on the agreement, Phil Gould, Chief Executive Officer of Provalis
said 'We announced in 2002 that we would focus all of our resources on our
Medical Diagnostics and Pharmaceuticals businesses, and would seek partners to
continue the development of our vaccine development programmes. We are,
therefore, delighted to have reached this agreement with a major worldwide
player in vaccine development such as Chiron Vaccines. This, together with the
earlier deal with GlaxoSmithKline for Haemophilus Influenzae antigens, delivers
potential long term upside for our investors.'
END
Provalis' Internet Website;
http://www.provalis.com
pachandl
- 12 Jul 2004 11:46
- 3 of 75
Further proof that Provalis management is turning the corner. Improved 2nd quarter growth, cash balance good, acquisition strategy in place, and G5 marketing beginning.
Provalis PLC 12 July 2004
For Immediate Release
Trading update for Financial Year 2004
G5 now branded as in2it(TM) and to be unveiled at the Diabetes Educators Meeting in Indianapolis in mid-August
Provalis plc (LSE: PRO; NASDAQ:PVLS), the Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce that its unaudited results for the
financial year ended 30th June 2004 are in line with market expectations with:-
Unaudited Group sales of 12.9m;
Pharmaceutical sales 5 per cent ahead of last year at 11.4m;
Medical Diagnostics sales of Glycosal(R) improving in the second half of
the year, with the business achieving annual sales of 1.5m; and
Net cash of 1.8m at 30th June 2004, with an unused bank facility of
up to 3.0m.
Pharmaceutical Developments
The profitable Pharmaceuticals business continues to pursue a number of
development projects, particularly the acquisition of further products and the
enhancement of margins on its current product range. Preparations are already
underway for the launch of Erdotin(R), its new mucolytic, onto the UK and Ireland markets early in 2005.
in2it(TM) Chosen as the Brand Name for Provalis' G5 Diagnostic Platform
Preparations for the launch of Provalis' in2it(TM) A1c(previously code named
G5), our new 'point of care' diabetes management system, in Autumn 2004 continue
following the filing of the regulatory dossier in the USA in mid-June. Interest
in the product is exceeding our expectations, with our in-house US sales force
already receiving enquiries from a number of health management organisations and
distributors. in2it(TM) A1c is to be formally unveiled at the American Diabetes Educators Meeting in Indianapolis in mid August.
Phil Gould, Chief Executive of Provalis, commented, 'We are pleased that the 2nd
half of the year has seen stronger Group sales. In addition, completion of
in2it(TM) A1c (the brand name for G5), our new diabetes management system, and its filing with the US FDA, were significant developments for the Group. The
projected Autumn launch of in2it(TM) A1c in the US, using our own direct sales
force, is the next important milestone in developing a branded point of care
diagnostics business focused on chronic disease.'
END
Provalis' Internet Website
Oakapples142
- 05 Aug 2004 09:54
- 4 of 75
Nice jump into the blue this morning - but why ?. All buys so far even if the last two have been recorded as unknown
pachandl
- 05 Aug 2004 10:11
- 5 of 75
Probably just a reaction to the recent downward price movement. I would hope to see a slow rise all the way to the next set of results on Sept 16th. I should also add that G5 FDA approval should come in early September, with product launch in October.
Oakapples142
- 19 Aug 2004 12:52
- 6 of 75
pachandl - approval has come two weeks early - 28% increase and still buying - a good set of results in 3 weeks should see this little gem back to past glory and beyond.
pachandl
- 23 Aug 2004 09:57
- 7 of 75
Oak - back from my hols and nice to see the good news. Good results plus a clear marketing strategy for G5 will see this past the 10p mark within a few weeks.
Oakapples142
- 26 Aug 2004 13:31
- 8 of 75
Oh dear what now - just as I was getting used to being in the blue - It has to-day left me feeling that colour. Why why why???
pachandl
- 06 Sep 2004 14:57
- 9 of 75
Provalis PLC
06 September 2004
For Immediate Release 6 September 2004
PROVALIS PLC
NOTIFICATION OF PRELIMINARY RESULTS
for the year ended 30 June 2004
Results Date: Friday 17 September 2004
On behalf of our client, Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical
Diagnostics and Pharmaceuticals Group, we notify the London Stock Exchange that
the Company will now be announcing its Preliminary Results for the year ended 30
June 2004, on Friday 17 September 2004.
The following meetings will be held on the day of the results, at Buchanan
Communications, 107 Cheapside EC2V:
Analysts : 10.00 am
Press : 11.30 am
Private Client Brokers Lunch : 12:45 pm
Provalis had originally announced that results would be announced on Thursday
16th September. The Company trusts that this one day change will not cause any
inconvenience.
For further information please call:
Lisa Baderoon
Buchanan Communications Tel: 020 7466 5000
This information is provided by RNS
The company news service from the London Stock Exchange
pachandl
- 13 Sep 2004 19:38
- 10 of 75
A reasonable tick up today - helped by Pro's performance on the Nasdaq. Also accompanied by better than avergae volume - let's hope that some contract announcement with one of the USA hospitals will follow over the next few weeks in order to maintain current momentum.
pachandl
- 17 Sep 2004 11:45
- 11 of 75
A reasonable report, some good news on in2it potential demand, and nice to see that the institutions did not subscribe to the rights issue at a ridiculously low price. Pach.
Provalis FY loss widens as expected; in2it takes off in US UPDATE
AFX
LONDON (AFX) - Provalis PLC said its loss before tax and exceptionals widened in the year to June 30 2004, as expected. The group also highlighted the exceptionally positive response it has received in the US for its new 'point of care' diabetes diagnostic product in2it A1c.
Group sales for the year fell to 12.9 mln stg from 14 mln in 2003 and the board said current sales in both its businesses are in line with expectations.
In the year under review pharmaceutical sales advanced to a record 11.4 mln stg from 10.9 mln but Medical Diagnostics sales, despite a recovery in the second half, fell to 1.5 mln from 3.1 mln.
Provalis also announced a placing to raise 2.6 mln stg today to help satisfy the 'exceptional and unexpectedly high demand' from US customers for in2it A1c.
The placing for cash of 33,066,000 new ordinary shares was predominantly with institutional investors and at a price of 8 pence each.
Commenting on the full year results, chairman Frank Harding said the highlight of the last year has been the completion of the development of in2it. He said the product has been cleared for sale in the US by the FDA and granted CLIA waiver and the company is now readying itself for its launch onto the US market in the autumn.
'We believe in2it A1c will be the best point of care diabetes testing product that is commercially available.'
Chief executive officer Dr Phil Gould added that the next year will be an exciting one for Provalis.
The US launch of in2it will be followed by the Pharmaceuticals business launching Erdotin in the UK and Ireland early in 2005. The company then anticipates applying for US regulatory approvals for the second test for the in2it diagnostic platform in the first half of calendar 2005.
The board said it remains committed to building a viable, fast growing and diversified healthcare group that will achieve profitability at the earliest opportunity. 'We believe that the step change in our diagnostics sales potential in the US, coupled with the sound profitable base of our Pharmaceuticals business, will lead to a revaluation of the company by the market.'
newsdesk@afxnews.com
pachandl
- 22 Sep 2004 12:18
- 12 of 75
Seems to be attracting buyers when the price falls below 8p. 10 day and 50day MA's intersected in an upward direction (last week). Reasonable evidence of a double-bottom having formed. If so, 7.85 mid-price might easily become a low-point resistance level. By all means shoot me down in flames when things go horribly wrong this afternoon and the share price plummets. Anyone else following this share?
apple
- 22 Sep 2004 12:53
- 13 of 75
I am, why did you start a new thread?
I've got a better selection of charts at the top of the other one.
I sold at 9.9p earlier this year but am watching for convincing evidence of profits before I decide whether it is worth buying again.
pachandl
- 22 Sep 2004 16:16
- 14 of 75
Schroders increases stake to 10% - as notified today. Obviously someone sees potential, although fund managers are notoriously wrong when choosing small cap stocks (unless they are employed by Artemis)!
pachandl
- 25 Sep 2004 12:13
- 15 of 75
DT has a short piece about Provalis in the Money Section - mentions concerns about loss of Falk products but recognises potential for in2it. It concludes that the share is "very risky - but the potential upside could be high". It seems a fair reflection of the current position.
IC has Pro as fairly priced but recognises that the US demand for in2it is positive if it can be sustained.
Overall, the press coverage is mildly encouraging although no-one is going to put their head above the parapet until there is evidence of a sustainable order pipeline in the US.
pachandl
- 27 Sep 2004 18:52
- 16 of 75
Interesting 750k trade at the end - seems to be a buy if you look at the real bid/offer spread. I wonder whether any other instituion is buying in - probably wishful thinking!
pachandl
- 15 Oct 2004 16:20
- 17 of 75
Hatman's chart analysis on ADV is proving unerringly accurate - we are currently in the third wave (3rd part) of a 5 wave pattern. MA lines all starting to point upwards with interesting dissection of 50 and 200 yesterday. A positive update on in2it orders at the next AGM (scheduled for Nov 4th I believe) would really create a firm foundation for upward momentum for the next two months.
pachandl
- 18 Oct 2004 10:29
- 18 of 75
I would expect an RNS soon re some institutional buying. 500k buy at 8.5p and a lot of sells soaked up last week.
pachandl
- 05 Nov 2004 10:26
- 19 of 75
Slowly but surely:
LONDON (AFX) - Provalis PLC, the medical diagnostics and pharmaceuticals group, said current trading is ahead of last year and in line with market forecasts.
The company also said first shipments to the US of its fully automated diagnostic test platform in2it Alc is planned for this month and that US demand for the product continues to grow strongly.
In the text of a statement to today's AGM, chairman Frank Harding said: 'With the first shipments of in2it A1c now imminent, further tests being developed for the in2it platform and the planned launch of Erdotin, 2005 promises to be a busy and productive year for Provalis. We anticipate 2005 as being the year which sees significant progress towards Provalis' emergence as a sustainable, growing and profitable healthcare group.'
Provalis said the highest margins on sales of in2it occur in the US and the strong demand from that country means production for this market will take all the company's capacity until summer 2005.
'We do, however, expect to gain European regulatory approval shortly and, as we are already in discussions with a number of pan-European distributors, we will be in a position to launch in2it A1c in Europe as soon as capacity is available,' Harding said.
The chairman said the withdrawal of Merck's Vioxx from the market last month gave Provalis the opportunity to promote its Diclomax product, a medicine for use in the treatment of musculo-skeletal disorders,.
'Although this campaign has only just started, we have seen some early signs of a potential increase in demand for Diclomax,' he said.
He said he hopes the increased sales from the campaign will mitigate some of the negative effects increased generic competition will have on Diclomax.
Finally, Harding said Erdotin, Provalis' new mucolytic product for use in a number of respiratory illnesses, continues to progress through registration and the company remains on schedule to launch the product early in 2005.
newsdesk@afxnews.com
eurofox
- 21 Nov 2004 11:44
- 20 of 75
From Supermum on ADVFN:
PRO coming off a support at just below 6p as a double bottom and broken through the shorter term down trend through 8p, I'd look at that as support - at 9.5 its in a resistance area and working its way through, once its through 10.5 - I would say that it may stand a chance... its def not a stock that will go up in a straight line - there will be dips
pachandl
- 22 Nov 2004 09:23
- 21 of 75
LONDON (AFX) - Provalis PLC said has now made the final payment to Pfizer Inc for Diclomax, which it acquired in Dec 2001 for 14.5 mln stg .
The price was to be paid via an initial 1.9 mln stg and further instalments over three years.
Provalis chief executive Phil Gould said: 'In the three years since Provalis acquired Diclomax, the product has remained profitable, sales have been maintained above 6 million pounds per year and market share has been increased.
'The annual payments to Pfizer have totalled 4.6 million pounds each year, and with this final payment having been made the cash generated from sales of Diclomax is now available to fund the further development of the group,' he added.
newsdesk@afxnews.com
lam