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
- 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
pachandl
- 22 Nov 2004 11:41
- 22 of 75
In the light of the current controversy surrounding Cox-2 inhibitors, I would have thought that Diclomax sales will remain steady for a couple of years. This should contribute 4m+ to the bottom-line, enabling further platform development of in2it. Currently the sp seems stuck in the resistance area but this seems quite positive in the light of the large number of sells last week. Keeping my fingers crossed - not a share for widows and orphans.
pachandl
- 02 Dec 2004 12:20
- 23 of 75
The recent price drop suggests that momentum has stalled. Pro is a small company that has to prove itself before any real buying can take place. The MMs obviously want to drum up some turnover or they will get nothing. Without newsflow the only thing that the MMs can do is drop the price. I am hoping for consolidation around the current range but nothing will happen until Pro management makes a positive statement. Hatman's analyis on Adv had proved unerringly accurate but the wave theory has now dissipated and we need to find a solid base again. A shame - I was getting quite excited!
pachandl
- 02 Dec 2004 15:39
- 24 of 75
6.9mill sell - are people jumping ship or has a big seller finally left the scene clearing the way for an upward movement?
pachandl
- 03 Dec 2004 09:35
- 25 of 75
Finally some positive news to stabilise the share price:
Provalis PLC
03 December 2004
For Immediate Release 3rd December 2004
Provalis plc
Provalis Makes First Shipments of in2it(TM) A1c to the US
in2it(TM) A1c Exhibited at Medica in Dusseldorf to support European launch
Provalis plc (LSE: PRO; NASDAQ: PVLS), the Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce that its Medical Diagnostics
business is today making the first commercial shipment of in2it(TM) A1C to the
US. in2it(TM) A1c, Provalis' new, fully automated, diabetes diagnostic test, is
sold directly to a network of sub-distributors in the US by Provalis Diagnostics
USA, the US based sales organisation established by Provalis earlier this year.
In addition, Provalis exhibited in2it(TM)A1c at Medica, Europe's leading
exhibition of medical diagnostic equipment, last week. Response from attendees
was very positive and discussions are on-going with selected distributors
regarding the product's launch in Europe, which is scheduled for the Summer of
2005.
Phil Gould, Chief Executive Officer of Provalis, said 'I am delighted that
shipment of in2it(TM) to the US market is now underway. We are extremely pleased
by the enthusiastic response to the product in the US, with orders continuing to
build following the exceptionally strong response from many sectors of the US
healthcare market. in2it(TM)'s ease and speed of use, economic pricing and
laboratory-standard performance have been major selling points for us and we
look forward to a steadily increasing stream of weekly shipments over the next
few months and to European launch in Summer 2005.'
END
Provalis' Website;
http://www.provalis.com
pachandl
- 13 Dec 2004 09:35
- 26 of 75
Excellent news - also ensures that we are not just a one product company.
Provalis PLC
13 December 2004
For Immediate Release 13th December 2004
Provalis plc
Provalis signs Vaccine Option Agreement with Aventis Pasteur
Provalis plc (LSE: PRO; NASDAQ:PVLS), the Medical Diagnostics and
Pharmaceuticals Group, today announces that it has signed an option agreement
with Aventis Pasteur, the vaccines business of the sanofi-aventis Group, for the
development of vaccine candidates to prevent streptococcus pneumoniae infection.
Under the terms of the agreement, Aventis Pasteur is granted a 24 month
exclusive option to evaluate Provalis' protein based antigen vaccine candidates
to prevent streptococcus pneumoniae infection. Aventis Pasteur will pay an
initial option fee to Provalis and will pay all costs, back dated to May 2004,
connected with the patents relating to these vaccine candidates. Aventis Pasteur
has the right to enter into an exclusive license for these vaccine candidates on
pre-determined terms, which include multi-million dollar milestone payments and
commercial royalty rates on any product commercialised.
Commenting on the agreement, Phil Gould, Chief Executive Officer of Provalis,
said, 'We are delighted to have reached this agreement with a world-wide player
in vaccine development such as Aventis Pasteur. This now represents our third
major agreement within our vaccine portfolio - the others being with
GlaxoSmithKline and Chiron Vaccines - and completes our partnering programme.
This means we are committed to no further spend for the Group, whilst retaining
the potential to generate considerable upside for our shareholders in the
future.'
END
Provalis' Internet Website ;
http://www.provalis.com
pachandl
- 08 Jan 2005 11:32
- 27 of 75
A reasonably positive interim trading statement - but it is important that the necessary increase in manufacturing capacity is achieved by August this year.
RNS Number:1177H
Provalis PLC
07 January 2005
For Immediate Release 7th January 2005
Provalis plc
Half Year Trading Update
Pharmaceutical sales advance by 5%
Medical Diagnostics makes first sales of in2it(TM) A1c to the US
Provalis plc (LSE: PRO; NASDAQ:PVLS), the international Medical Diagnostics and
Pharmaceuticals group, is pleased to announce that unaudited sales for the half
year to 31st December 2004 were approximately #6.7 million. This is 5% ahead of
the same period in the previous year (#6.4 million), and is in line with the
Board's expectation.
During the first half of 2005 significant progress was made in both operating
businesses:-
Strong Sales by Pharmaceuticals Business
Sales by the Pharmaceuticals business were some #6.1 million, up 5% on the same
period last year. The second quarter sales were particularly strong, despite the
impact of wholesalers deferring purchases until after the 7% PPRS price
reduction takes effect in January 2005.
Diclomax(R) continues to sell well, helped by the withdrawal of Vioxx from the
market in October 2004 and the continuing uncertainties over other COX2
inhibitors, although the benefit of this has been counter-balanced by an
increase in generic competition. Calceos, our treatment to prevent or treat
osteoporosis, continued to make strong progress in the first half, with sales
significantly advanced over last year.
Medical Diagnostics Business Launches in2it(TM) A1c in the US
Activities within the Medical Diagnostics business were concentrated on
preparing for the US launch of in2it(TM) A1c following receipt of FDA clearance
in August 2004. Since then, the Company has worked with its various
manufacturing partners to bring the product on stream, with the first shipment
of in2it(TM) A1c to the US made in the first week of December.
Sales of the product in the US are being managed directly by Provalis' own sales
team, whose members each have extensive diagnostic experience within the US
diagnostics market. This sales team has established a number of preferred
distributors and key accounts in the US, and has helped achieve early take up of
in2itTM A1c. Indeed, interest in the product continues to grow as we expand our
distribution coverage in the US.
Sales of in2it(TM) A1c will progressively increase through the second half of
the year although, as previously announced, sales will be limited during that
period by our current manufacturing capacity of test cartridges. However,
following the successful fund raising in September 2004, we have begun the
staged implementation of automated manufacture of test cartridges. This remains
on track for completion during the summer of 2005, and should give a several
fold increase in production capacity.
Sales by the Medical Diagnostics business in the first half were some #0.6m,
principally from the supply of Glycosal(R) test cartridges to our existing
distributors. The business remains on course to meet market expectations for
the full year as sales of in2it(TM) A1c increase.
Phil Gould, Chief Executive Officer of Provalis plc, commented: "The first half
year has seen increased sales by our Pharmaceuticals business and a significant
achievement by our Medical Diagnostics business with the approval and launch of
in2itTMA1c in the US. In the second half of the year we will concentrate on
meeting the US demand for in2it(TM) A1c and continuing the development of two
further tests for the in2it(TM) platform, whilst continuing to maximise the
performance of our Pharmaceuticals business."
The Company's interim figures and an overview of trading expectations for the
full year will be presented in March 2005.
END
Provalis' Website; http://www.provalis.com
pachandl
- 18 Jan 2005 15:06
- 28 of 75
Is someone building a stake - the sp has not exactly crashed given the constant flow of sells. Probably wishful thinking.
pachandl
- 25 Jan 2005 10:11
- 29 of 75
Provalis PLC
25 January 2005
For Immediate Release 25 January 2005
PROVALIS PLC - NOTIFICATION OF INTERIM RESULTS - for the six months ended 31 December 2004
Results Date: Tuesday 1 March 2005 - Web Cast Notification
On behalf of our client, Provalis plc (LSE: PRO; NASDAQ: PVLS), the
International Medical Diagnostics and Pharmaceuticals Group, we notify the
London Stock Exchange that the Company will be announcing its Interim Results
for the six months ended 31 December 2004, on Tuesday 1 March 2005.
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
Running simultaneously to the briefing at 10.05 am will be a live web cast of
the results presentation. To connect to the web cast facility please go to the following internet address approximately 5 minutes (10.00 am) before the start of the briefing: http://mediaserve.buchanan.uk.com.
This presentation will also be available on the Provalis website later that day
at: www.provalis.com
For further information please call:
Lisa Baderoon Buchanan Communications Tel: 020 7466 5000
pachandl
- 25 Feb 2005 09:43
- 30 of 75
The market does not seem to have reacted favoyrably to this announcement - although the saving of money will almost certainly avioid any further need for a cash-call (IMHO).
LONDON (AFX) - Provalis PLC said it intends to terminate its listing on NASDAQ.
As soon as possible thereafter, it said it will suspend its registration and reporting obligations to the United States Securities and Exchange Commission (SEC).
Provalis said a review of its secondary listing on NASDAQ concluded that the significant costs and management time necessary to comply with additional requirements introduced by recent changes in United States securities laws far outweighed the benefits of the listing.
This action, which is expected to save the group some 700,000 usd between now and June 30 2006 and at least 400,000 usd in each year thereafter, should not cost more than 50,000 usd.
newsdesk@afxnews.com
pachandl
- 01 Mar 2005 08:00
- 31 of 75
Highlights of interims - reasonable progress seems to be the order of the day.
For Immediate Release 1st March 2005
Provalis plc
Interim Results for the six months ended 31 December 2004
Provalis plc (LSE: PRO; NASDAQ: PVLS), the International Medical Diagnostics and
Pharmaceuticals Group, is pleased to announce its interim results for the six
months ended 31 December 2004.
Highlights
Group
Group sales 6.7m (1H2004: 6.4m) with gross profit 3.5m (1H2004: 3.6m)
Group operating loss of 2.7m (1H2004: 1.8m) principally reflecting
additional costs of the US sales operation
Group loss for the period of 1.7m; (1H2004: 2.0m)
Share placing in September raised 2.5m net to support manufacture of
in2it(TM)
Closing cash of 1.1m augmented by the scheduled receipt of 2.0m from
Dr Falk Pharma in January
5.0m three year credit facility arranged with Bank of Scotland in
February 2005
Completion of payments to Pfizer for Diclomax
Option for vaccine license agreement granted to Aventis Pasteur
Medical Diagnostics
US FDA 510K clearance and CLIA waiver of in2it(TM) A1c
US sales management team generating significant demand and orders for
in2it(TM) A1c
First shipment of in2it(TM) A1c to the US made in December 2004
Continuing strong demand for in2it(TM) from US market with shipments steadily
increasing from February
Major interest in in2it(TM) from international markets with European launch
expected by autumn 2005
Project for major increase in cartridge manufacturing capacity for in2it(TM)
on course for completion by July 2005
Further tests for the in2it(TM) platform in development
Pharmaceuticals
Sales of 6.1m (1H2004: 5.8m) with net profitability of 0.8m (1H2004; 1.0m)
Diclomax(R) continued to sell well (2.8m) but market remains turbulent
following Merck withdrawal of Vioxx in October 2004 and increased generic
activity
Sales of Dr Falk products at 2.5m; marketing and distribution of these
products ceased in December 2004 and final compensation payment received by
Provalis in January
Erdotin(TM) continues to progress through regulatory process towards UK and
Irish approvals
Phil Gould, Chief Executive Officer of Provalis plc, commented: 'The first half
of the year saw Provalis achieve most of the key strategic objectives necessary
to provide the platform for significant sales growth in the next financial year.
Most importantly, our US sales team generated strong and continuing demand for
in2it(TM) A1c following the grant of regulatory approvals in August.
Demand for in2it(TM) A1c continues to exceed our manufacturing capacity for test
cartridges. The project to deliver a several fold increase in capacity is well
advanced and should be completed by early in the next financial year. This would
allow sales of in2it(TM) A1c to accelerate markedly and, despite the challenges
facing our Pharmaceuticals business, rapidly move the Group as a whole towards
profitability.'
END
pachandl
- 02 Mar 2005 18:19
- 32 of 75
It's about time the directors started reaching into their pockets!
Provalis chief exec, finance director buy shares
AFX
LONDON (AFX) - Provalis PLC said chief executive Phil Gould, finance director Peter Bream and director FA Harding have each acquired 100,000 ordinary shares in the company at 5.75 pence each.
Gould now holds 450,689 shares, representing 0.12 pct. Bream now holds 221,462 shares, representing 0.06 pct, and Harding now holds 366,058 shares, representing 0.1 pct.
newsdesk@afxnews.com
slm/
pachandl
- 04 Mar 2005 19:38
- 33 of 75
Inv Chr has Pro as "fairly priced" with loss of Dr Falk products and increased generic competition for Diclomax squeezing profits, but counter-balanced by demand for in2it exceeding supply. Probably a faiur assessment at present until increased capacity comes on stream.