terrettp
- 03 Feb 2003 13:16
GW Pharmaceuticals share price dived this morning after a Sunday newspaper claimed GlaxoSmithKline had pulled out of talks to license the companys cannabis medicines. But insiders claim the news is ancient history and is an cynical attempt by an undisclosed party to push the share price down and make it cheaper to buy.
Stock fell 8% to 161p in early trading on Monday and GW Pharmaceuticals was forced to issue an RNS statement in response. The company insists it is still on track to sign its first commercial partnership in the first half of 2003 and to submit its regulatory application to the Medicines Control Agency during the first quarter of 2003.
Many of the mornings trades were sells by retail investors. However stock recovered quickly after institutions bought in.
The Sunday Telegraph said yesterday that GWs chairman Geoffrey Guy had been in discussions with the drug giant to license out its pain relief drug for MS sufferers for an upfront payment of 20 million and royalties of 20-30% but GSK had abandoned the talks. The story did not appear in any other newspaper.
An insider said: GSK were extremely close to signing up and put in a lot of money but the deal fell over for political reasons to do with the US. But this is all ancient history. Other negotiations are going swimmingly. Whoever is behind the story in the Sunday Telegraph probably has an interest in pushing down the shares so they can buy in and get a pretty good return when a licensing deal is signed.
GWs managing director Justin Gover refused to confirm or deny whether GSK had been involved in talks with the company. We do not know the source of the story but its frustrating for us and its difficult to respond to speculation, he said. But were not just looking at one company and one deal.
Analysts failed to balk at the Telegraph story, which they described as irrelevant.
'I would have been surprised if theyd signed a deal with Glaxo, said Dr. Julie Simmonds, analyst at Evolution Beeson Gregory. It doesnt fit in with the style of the management because theyd have to give up control.
House analyst Dr. Jonathan Kwok at Collins Stewart was philosophical. It doesnt make me concerned. If when Antisoma was in discussions with Roche deals with other companies had fallen over, would it have made any difference? When the deal was announced the share price still doubled.
GW still has a healthy 20 million in the bank and, market rumours aside, a licensing deal should provide welcome upside for the share price.
grenvillegiles
- 30 Dec 2004 10:32
- 13 of 45
Any Ideas as to why the price drop today?
i facer
- 30 Dec 2004 12:19
- 14 of 45
there is no news, it is a combination of low volume, mms playing games, and sells outweighung buys....nothing tio worry about...a good top up opportunity
grenvillegiles
- 30 Dec 2004 12:35
- 15 of 45
Thanks ifacer I hunted around for news but none to be had so drew the same conclusions.. am a bit jittery after having been on the wrong end of PET. If only I had the funds to top up...
i facer
- 31 Dec 2004 14:31
- 16 of 45
you'll be fine with this mate, the approval in canada will put pressure on the uk in the run up to the appeal, and accordingly the price will increase linearly
dafter
- 10 Feb 2005 21:04
- 17 of 45
check out the chart
ethel
- 16 Feb 2005 18:59
- 18 of 45
I think that we have to wait until the UK elections are over for any rns on this.Blair has got cold feet on soft drugs,in whatever form they are used.
Big Al
- 16 Feb 2005 19:06
- 19 of 45
I did nicely trading this share long in the Autumn.
Unfortunately, it yet again had problems after the New Year. There'll always be fundie buyers methinks. ;-)
leslielipert
- 19 Apr 2005 12:00
- 20 of 45
Appoval at last!
GW Pharmaceuticals PLC
19 April 2005
Embargoed until 1135 19 April 2005
GW Pharmaceuticals plc
('GW' or 'the Company')
GW Announces Regulatory Approval of Sativex(R) in Canada
GW announces that Sativex(R) has been granted regulatory approval in Canada for
the symptomatic relief of neuropathic pain in multiple sclerosis.
Dr Geoffrey Guy, Executive Chairman, said, 'We are delighted that Sativex has
received regulatory approval in Canada. This event marks the world's first
approval of a cannabis derived medicine. This first regulatory approval has been
obtained by GW in just over six years since the Company's development programme
commenced, a highly significant achievement. We are now working with our
Canadian marketing partner, Bayer, towards the launch of Sativex throughout
Canada in late Spring.'
The full text of a joint statement released today with Bayer Healthcare, follows
below:
HEALTH CANADA FIRST TO APPROVE A NOVEL CANNABIS DERIVED PHARMACEUTICAL TREATMENT
FOR PEOPLE WITH MULTIPLE SCLEROSIS
TORONTO, Ontario -- (19 April 2005) - Health Canada has approved Sativex(R)
(Cannabis sativa L. extract) a new drug developed as adjunctive treatment for
the symptomatic relief of neuropathic pain in adults with multiple sclerosis
(MS). Canada becomes the first country in the world to approve Sativex, a novel
prescription pharmaceutical product derived from components of the cannabis
plant shown to have therapeutic properties. Sativex is administered via a spray
into the mouth.
Health Canada has approved Sativex with conditions, under the Notice of
Compliance with Conditions (NOC/c) policy. This authorization reflects the
promising nature of the clinical evidence which will be confirmed with further
studies. Products approved under Health Canada's NOC/c policy, have demonstrated
promising benefit, are of high quality and possess an acceptable safety profile
based on a benefit/risk assessment for the approved use.
'Effective pain control and management are extremely important in a disease like
MS,' said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain
Management Centre, Mount Sinai Hospital, Toronto, Ontario. 'The approval of
Sativex in Canada reflects the urgent need for additional treatment options in
the field of neuropathic pain in MS.'
Neuropathic pain
Pain is a common symptom of MS occurring in up to 86 per cent of people with MS.
(1) Neuropathic or nerve pain can occur spontaneously or can be provoked by
touch, temperature or movement. It is estimated that 50 per cent of people with
MS suffer from chronic neuropathic pain.(2),(3),(4) The most common descriptions
of neuropathic pain are of freezing, cold or burning sensations usually of the
limbs and most often of the lower extremities.(5) Many individuals with
neuopathic pain respond inadequately to current treatment options.(6),(7)
'It's hard to explain to someone who has never felt this type of pain. It's like
being plugged into an electric socket all the time,' said Steve Walsh, who
suffers from MS and has lived with neuropathic pain for five years. 'At times,
putting on clothes or anything touching me can be too much to take,' he added.
Data demonstrates efficacy
While there is no complete cure for MS or neuropathic pain, a double-blind
placebo controlled parallel group study demonstrated that Sativex provided
significantly greater pain relief than placebo. Sativex also significantly
reduced pain-related sleep disturbance.
Principal components
A product resulting from the pioneering research efforts of UK-based GW
Pharmaceuticals plc and marketed in Canada by Bayer HealthCare, Pharmaceuticals
Division, Sativex is the first product indicated in Canada as adjunctive
treatment for the symptomatic relief of neuropathic pain in MS.
Its principal active cannabinoid components are delta-9-tetrahydrocannabinol
(THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is
2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each time
it is used.
'The approval of Sativex is good news for the Canadian MS community. People
living with MS and neuropathic pain need new options to address their pain.
Sativex will likely be welcomed by the many people with MS, whose quality of
life has been further compromised with neuropathic pain,' said Dr. William J.
McIlroy, National Medical Advisor, MS Society of Canada.
How Sativex works
Sativex is administered through a spray pump under the tongue or on the inside
of the cheek, providing reliable, self-administered pain relief. The spray
formulation allows for more flexible dosing than an oral tablet, well suited to
the variable nature of neuropathic pain experienced by people with MS.
'Because Sativex is designed for self-administration, this allows for flexible
dosing and puts the patient in control of their pain,' said Dr. Gordon. 'This is
very important since pain severity varies between different patients and even in
the same patient at different times.'
Sativex and side-effects
In clinical trials, the most frequent side-effects included nausea, fatigue,
dizziness and application site reactions. Side-effects were usually mild or
moderate in severity and often resolved with down-titration or interruption of
treatment.(8)
Sativex is expected to be available through Canadian pharmacies by late Spring
2005.
Multiple sclerosis (MS) in Canada(9)
MS is a disease of the central nervous system and is the most common
neurological disease affecting young adults in Canada. Approximately 50,000
Canadian men and women have the disease and each day approximately three more
people are diagnosed. MS is most often diagnosed in people between the ages of
20 to 40 years of age.
- Ends -
Enquiries:
GW Pharmaceuticals plc Today: (44) 20 7067 0700
Dr Geoffrey Guy, Chairman Thereafter: (44) 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR (Europe/Canada) (44) 7885 638810
John Pastuovic, Press and PR (US) 001 312 925 9092
Weber Shandwick Square Mile (44) 20 7067 0700
Kevin Smith
Bayer Inc.
Lori Ann Horrigan 001 416 240 5252
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading,
innovative companies in the health care and medical products industry. In 2004,
the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion
Euro.
The company combines the global activities of the divisions Animal Health,
Biological Products, Consumer Care, Diabetes Care, Diagnostics and
Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that
will improve human and animal health worldwide. The products enhance well-being
and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group Management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in our public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission (including our
Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a
pharmaceutical research and development program to develop non-smoked
cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a
market on the London Stock Exchange.
Full details of GW and the company's clinical trials program can be found at
www.gwpharm.com
. GW's clinical research program is being carried out by a team
of pharmaceutical professionals experienced in drug development and, in
particular, the development of plant-based medicines and drug delivery systems.
This news release may contain forward-looking statements that reflect GW's
current expectations regarding future events, including the clinical development
and regulatory clearance of its products. Forward-looking statements involve
risks and uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors, including (inter alia), the
success of GW's research strategies, the applicability of the discoveries made
therein, the successful and timely completion of clinical studies, including
with respect to Sativex and GW's other products, the uncertainties related to
the regulatory process, and the acceptance of Sativex and other products by
consumers and medical professionals.
References:
--------------------------
(1) Ehde DM et al. Multiple Sclerosis 2003; 9; 605-611.
(2) Archibald CJ, et al. Pain 1994; 58:89-93.
(3) Sketris IS, et al. Clinical Therapeutics 1996; 18(2):303-318.
(4) Moulin DE, et al. Neurology 1988;38:1830-1834.
(5) Multiple Sclerosis International Federation
www.msif.org/print.rm?id=10188
(6) Harden N and Cohen M. Journal of Pain Symptom Management 2003;
25 (5 Suppl):S12-S17.
(7) New Directions in Neuropathic Pain: Focusing Treatment on Symptoms and
Mechanisms. Royal Society of Medicine Press Ltd.: 2000.
(8) Sativex Product Monograph - April 2005
(9)
cellby
- 13 Nov 2005 22:28
- 21 of 45
the spanish are taking this on in 1 region by demand of the people ,it seems like a good way around the political mess with a cannabis based treatment.stop the need of a lot of people haVing to put money in the hands of scum (drug dealers).if this co can get a reVenue stream going they should start a rise to there old highs .i bought at 122.5 back in april on the news of there canada aproVal ,going to get in at these lows see if i can bridge that gap.
cellby
- 15 Nov 2005 08:45
- 22 of 45
nice rise today goVernment to allow sale in briton ,didnt buy yesterday there was a bit of pull back thought may of got in cheaper ,going to try on any dip but we are geting good news this co should keep moVing up.
cellby
- 16 Nov 2005 08:57
- 23 of 45
still moVe up now going to be released in briton telegraph haVe aVoid rec on this any more holders out there.
jj50
- 16 Nov 2005 09:24
- 24 of 45
Yes, celby - needs to move up a fair bit before I am in profit though!
If approved, it has to be a winner; arthritis/ms sufferers in real pain often
cannot tolerate conventional pain killers. I believe this is a spray which will be much gentler on the stomach. Keeping my fingers crossed!
cellby
- 21 Nov 2005 09:45
- 25 of 45
someone must haVe giVen this a good mention rising today it should keep going as more market open.
leslielipert
- 22 Nov 2005 09:53
- 26 of 45
upward again today - could more good news be out soon?
cellby
- 22 Nov 2005 19:47
- 27 of 45
15% more today broke the pound barier and held this product is going worldwide with them or they may get taken oVer its to big and to useful to stop now 240 or there about was its top its good for that again just need some more cash for working capital.
cellby
- 23 Nov 2005 08:39
- 28 of 45
early rise today the battle is on plenty of people taking there profits today its come nearly 100% from lows.
leslielipert
- 23 Nov 2005 08:58
- 29 of 45
Drugs Minister Paul Goggins has allowed imports of Sativex to satisfy its prescription to individual patients in the UK as an unlicensed medicine. Expect soon that GWP will be allowed to supply direct from UK soon. That will improve GWP cash flow.
UK, European and US approvals are also events to be expected. As are negotiations with major drugs company for distributions in areas not allocated to Bayer. GWP must be holding back on these to maximise deals.
GW has also developed a novel, secure and tamper-proof means of dispensing drugs. The technology provides high levels of security for dispensing drugs, whilst also enabling clinicians to remotely monitor and, if required, remotely control drug usage in real time This has not been highlighted for some time.
leslielipert
- 23 Nov 2005 16:14
- 30 of 45
I wonder how many people read this thread. Perhaps the title is out of date. Comments please if a new thread should be started. Suggestions for a new name would be appreciated. Also any insights to what is happening and as to where the share price might go.
leslielipert
- 12 Dec 2005 09:14
- 31 of 45
GW Pharma expands in Europe
GW Pharmaceuticals has signed up Spanish group Almirall to market its cannabis-based pain relieving drug Sativex in Europe.
The deal, which excludes the UK, will give GW a 'significant share' of long term product revenues and possible milestone payments worth up to 46m, including a 12m signing fee.
The payments are contingent on the successful completion of ongoing pivotal final stage phase III trials, regulatory approvals and the achievement of sales targets.
Privately-owned Almirall is Spain's largest pharmaceutical company.
Sativex, which is administered via a spray into the mouth, is in phase III trials for the treatment of Multiple Sclerosis symptoms, neuropathic pain and cancer pain.
Under the agreement GW will complete those trials, but GW said it expects to collaborate with Almirall on the development of Sativex in other indications, which the Spanish group will help pay for.
The signing fee boosts GW's cash pile to 22m.
'As one of the leading specialist European pharmaceutical companies, Almirall is exactly the profile of partner that we have been seeking for Sativex,' chairman Dr Geoffrey Guy said in a statement.
'GW's commercial strategy is to maximise the value of Sativex by retaining a significant interest in revenues from product sales whilst at the same time generating sizeable cash payments in the short term to meet GW's financial requirements.
'The terms of this agreement reflect the merits of this strategy,' he said.
Up 15.5 to 133 on this news. There is more good news to come.
cellby
- 12 Dec 2005 09:59
- 32 of 45
good news but a lot of selling we are held to this aproVal of final trials again ,been here with some other co .we were already selling in spain more countrys would follow.