Report
GW Pharmaceuticals Re Sativex




RNS Number:8627J
GW Pharmaceuticals PLC
13 December 2007



GW Welcomes Move by UK Regulator to Provide More Information for Sativex(R)
Prescribers


Porton Down, UK; 13 December 2007: GW Pharmaceuticals plc (AIM: GWP) welcomes
the publication today by the UK regulator, the Medicines & Healthcare products
Regulatory Agency (MHRA) of a Public Information Report on Sativex(R), GW\'s
cannabinoid spray medicine.


The MHRA has taken this unprecedented step due to its view of the \"huge public
interest\" in Sativex and the fact that approximately 1400 patients in the UK
have so far received the medicine on prescription on a named patient basis. New
patients continue to be prescribed Sativex every day. Hence, the MHRA considers
that it is in the public interest for potential prescribers to have further
information on the medicine.


Dr Geoffrey Guy, Chairman, said, \"We welcome the MHRA\'s appreciation of the
public interest in Sativex and recognition of the extent of prescription use of
Sativex in the UK. We continue to receive enquiries from UK physicians and
patients on a daily basis and this report will serve to provide them with more
information about the medicine and its use.\"


Dr Guy added, \"As we have previously announced, there is an outstanding efficacy
issue to be resolved prior to full regulatory approval for Sativex in the relief
of Multiple Sclerosis spasticity. This issue, detailed in the report, is being
addressed through an additional Phase III clinical trial, which commenced
recently.\"



Enquiries:

GW Pharmaceuticals plc Today: +44 20 7831 3113

Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: + 44 7885 638810

Financial Dynamics Tel: +44 20 7831 3113

David Yates

WHAT NOBODY IN THIS BABY?...YOU MUST BE ALL ON DRUGS OR BRAINDEAD

Drugs, now brain dead, sorry,

News Item Tues 18Dec07
Researchers in London have discovered a means of supressing the long-term, unwelcome effects of Canabis - it is hoped this might make it possible to prescribe it for people with MS, where they suffer considerable pain.
This is nowhere near Approval, but shows that the basic ingredient (canabis) might be better-refined. Not sure if this affects GWP - oddly no mention was made to "other solutions"; but that would have blown its chances for a News-slot.

Have been a "sufferer" of this share for a while now, but have noticed that since dec 07 it is moving slowly but surely incl a 4.4% hike today. Any rumours going round re the additional info required?

anyone there? up nearly 10% today but i can not find any news

GW Pharma's cannabis-based Sativex missed Phase III goal for MS pain - AFX
(Adds analyst reaction, live share price)

LONDON (Thomson Financial) - GW Pharmaceuticals Plc, the AIM-listed specialist in cannabis-based medicines, has announced that its Sativex lead product has missed a statistically significant result in its Phase III trial for MS central neuropathic pain, because of an 'unexpectedly large placebo response'.

In the study, 50 percent of Sativex patients experienced a pain reduction of at least 30 percent, the company said, the second largest response rate seen in any Sativex study and amongst the largest seen for any pain treatment in the published literature.

However, although the difference between the Sativex and placebo groups was clearly in favour of Sativex, it narrowly failed to reach statistical significance in this trial due to an unexpectedly large placebo response.

This study is one of three Phase III trials for Sativex underway in 2008, each of which targets a distinct indication. The other European Phase III study in MS Spasticity, requested last year by the UK regulator in order to gain approval in this indication and which involves a different trial design, is on track to report later this year.

Scientific director Stephen Wright told Thomson Financial news in an interview that the target in Europe was the spasticity indication, which reports Phase III results at the end of the year.

'Our primary target has always been spasticity in MS and that absolutely remains the case and we have a large study ongoing designed in agreement with the MHRA which, when positive, will meet their requirements for approval, and that will report around the end of this year,' he said.

'Neuropthic pain has always been in the spirit of expanding the indications of Sativex when it's approved. Clearly had we had an extraordinarily positive result with this study it could have led to an early approval but in fact it's really building the MS franchise of Sativex.'

He explained that the trial failed because patients were taking much larger doses of the placebo drug than Sativex, and that future studies would be designed on a same dose basis.

Managing director Justin Gover added that the company would be planning another trial in neuropathic pain, and that the body of evidence was 'compelling'.

'You should bear in mind that we've done multiple neuropathic pain studies, this is not the first by any means and in fact we've seen a host of positive outcomes for a number of previous neuropathic pain studies so the body of evidence that we have to support the neuropathic pain use of Sativex is compelling.'

Ibraheem Mahmood at Investec Securities said he was a buyer of the stock in the short term and long term and he would hold it in the medium term.

'I'm pretty confident about the trial result in MS spasticity. The other one is harder to tell (cancer pain) but what we can say about both of them is they don't have the dosing issue so I suspect today there'll be an over-reaction and then if it drops below 50 pence the stocks will be mopped up and I think it'll drift back again to 60 pence or 70 pence.

'Long-term good buy, short-term buy, medium term term hold,' he said.

Jacob Plieth at Edison Investment Research also said that the neuropathic pain result is 'of limited importance'.

'In the grand scheme of things it's of limited importance. The cancer is the focus in the US and spasticity is the focus in the UK,' he said.

'It's not like they have pulled the project,' he said.

At 9:41 a.m. GW shares were down 15.5 pence or 21.7 percent at 56.5 pence, off intraday lows of 49 pence.

ben.deighton@thomson.com

bsd/ejb/bsd/slm

GW REPORTS HIGHLY STATISTICALLY SIGNIFICANT RESULTS IN SATIVEX PIVOTAL PHASE III STUDY IN MS SPASTICITY




Expected Milestone Payment from Almirall of 8m




Porton Down, UK, 11 March 2009: GW Pharmaceuticals plc (GWP:AIM) today announces positive preliminary results from a pivotal Phase III double-blind randomised placebo-controlled study of Sativex in patients with spasticity due to Multiple Sclerosis (MS), who have achieved inadequate spasticity relief with existing therapies. This study was requested by the UK regulator in order to gain approval in this indication and following today's results, GW will file a regulatory submission in Q2 09.




This Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose. This study is the largest study GW has undertaken and recruitment was achieved in just ten months using 52 hospital sites in five countries - UK, Spain, Italy, Czech Republic and Poland.




The prospectively defined primary efficacy endpoint of the study - the difference between the mean change in spasticity severity of Sativex vs Placebo in Phase B - was highly statistically significantly in favour of Sativex (p=0.0002). The numeric difference between the two groups as measured on a Numeric Rating Scale was 0.84 units from a baseline of 3.89, greater than that achieved in previous studies. The difference between Sativex and placebo was also significant for a number of secondary endpoints. 74% of Sativex patients achieved an improvement of greater than 30% in their spasticity score over the entire study versus 51% on placebo (p=0.0003). In addition, statistically significant improvements were also seen in spasm frequency (p=0.005), sleep disturbance (p<0.0001), patient global impression of change (p=0.023), and physician global impression of change (p=0.005).




The study provides further evidence of Sativex's reassuring safety profile. The adverse event data in this study was superior to previous Sativex studies - an improvement which resulted from the modified dose titration regimen employed in the study.




Following these positive results, GW will submit a regulatory application in Q2 09 in the UK and, subject to discussion with Almirall, other selected European countries. Upon approval, Sativex will be marketed exclusively in the UK by Bayer HealthCare and in the rest of Europe by Almirall.




Dr Stephen Wright, GW's R&D Director, said: 'This Phase III study is a resounding success and provides further evidence that Sativex provides meaningful efficacy for people with spasticity due to MS. In the last six months, GW has reported three positive Sativex studies incorporating a design modified from previous studies and we are delighted that this new approach is producing such consistent positive results. We will file a European regulatory submission in Q2 09 and look forward to progressing the review during 2009.'




Milestone Payment




GW also announces today that it has signed an amendment to the Sativex licence agreement with Almirall. This amendment provides for the potential milestone payment to be received following this study result to reach 8m. The 8m milestone will become due upon Almirall electing to include a country within their licensed territory (Europe excluding UK) as part of the forthcoming regulatory submission to the UK. This decision is expected to be made within the next month.




Justin Gover, GW's Managing Director, said, 'GW has a history of maintaining a strong financial position and this increased potential milestone payment represents an attractive opportunity to further consolidate this position. We are delighted by the ongoing support and enthusiasm of our licensing partners for the commercial potential of Sativex.'




There will be a conference call for analysts today at 2.30pm and the corresponding presentation will be available on the investor relations section of the GW website (www.gwpharm.com). Analysts should contact Juliet Edwards at Financial Dynamics on 020 7269 7125 for details. A recording of this meeting will be available on the GW website later today.






Enquiries:




GW Pharmaceuticals plc
(Today) + 44 20 7831 3113

Dr Geoffrey Guy, Executive Chairman
(Thereafter) + 44 1980 557000

Justin Gover, Managing Director








Financial Dynamics
+ 44 20 7831 3113

David Yates / John Dineen








Investec Bank plc
+ 44 20 7597 4000

Patrick Robb







Notes to Editors




Sativex Prescription Use

Sativex is approved and marketed in Canada for the treatment of cancer pain and MS neuropathic pain. In addition, Sativex is available on prescription in the UK on a 'named patient' basis and has to date been exported to 22 countries around the world.




Sativex and MS Spasticity

Spasticity (spasms and stiffness) is one of the most common symptoms of MS occurring in as many as three-quarters of people with MS. Spasticity can affect many aspects of daily life, such as walking and sitting. Sativex aims to treat high need patients who have previously failed to gain adequate benefit from currently available anti-spasticity treatments




The indication of MS spasticity has been the sole focus of previous discussions with European regulatory authorities. The trial reported today was specifically requested by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), prior to obtaining approval for Sativex.




Prior to the study reported today, GW had accumulated a body of clinical data in approximately 700 patients with MS spasticity, including two pivotal Phase III trials as well as two supportive trials.




In February 2009, GW reported positive results from a placebo-controlled randomized withdrawal study of Sativex in patients with spasticity due to MS. This study showed that Sativex provides meaningful long term efficacy for people with spasticity due to MS, and will be important additional feature of the efficacy and safety data to be submitted in the forthcoming regulatory application.




GW expects to file a regulatory submission in Q2 09. Upon UK approval, GW will receive a 10m milestone payment from Bayer. On approval in Spain, GW will receive a further 2.5m payment from Almirall.




Sativex and Cancer Pain

Over one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Currently available opioid therapies do not yield sufficient relief in a substantial proportion of these patients and there is a clear need for new treatments.




Cancer pain is the lead indication for the development of Sativex in the United States. GW has completed a positive Phase II cancer pain study in Europe in 177 patients and is now carrying out a 336 patient Phase IIb/III study in collaboration with its partner, Otsuka Pharmaceutical Co. Ltd. Upon approval, Sativex will be exclusively marketed in the US by Otsuka.




About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.





This information is provided by RNS
The company news service from the London Stock Exchange

END


RESILFLVVIILLIA

are we going places? All seems to be going smoothly

COULD HIT 100P BY FRIDAY

SORRY TUESDAY

SATIVEX APPROVED IN UK JUDGING BY WHAT I'M HEARING...ABOUT BLOODY TIME TOO

SATIVEX REGULATORY UPDATE



UK AND SPANISH REGULATORS CONFIRM NO MAJOR ISSUES OUTSTANDING

Regulatory Process Now at Advanced Stage. Approvals Expected Q2 2010



Porton Down, UK, 18 March 2010: GW Pharmaceuticals plc (GWP:AIM) today provides an update on the progress of its regulatory submission for Sativex Oromucosal Spray for the treatment of the symptoms of spasticity due to Multiple Sclerosis. The regulatory submission was filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK acting as the Reference Member State.



The regulatory process has now reached "Day 150" of the decentralised procedure and both the UK and Spanish regulators have concluded that there are no major quality, safety or efficacy issues remaining to be resolved. Resolution is now required only of points of clarification related to finalisation of wording on the patient information leaflet. We expect this document to be reviewed by the regulators in the coming weeks.



Once the regulators have agreed final wording on the patient leaflet, the decentralised procedure can close and the process will enter its final phase. This final phase, known as the national phase, takes place separately in the UK and Spain and its purpose is to finalise local wording on product packaging and related documents.



GW therefore expects regulatory approval in the UK and Spain during Q2 2010.



Dr Stephen Wright, GW's R&D Director, said, "This is a major milestone in the regulatory process for Sativex, and for GW's future prospects. We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. This progress with Sativex also provides further validation of GW's cannabinoid platform and the significant long term promise of GW's portfolio of cannabinoid medicines."



Sativex will be marketed in the UK by Bayer Schering Pharma, and in the rest of the European Union by Almirall S.A. Upon UK regulatory approval, GW expects to receive a 10m milestone payment from Bayer. A further 2.5m milestone payment is payable by Almirall following both regulatory and pricing approval in Spain.



Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.



There will be a conference call for analysts today at 10.00am. Analysts should contact Juliet Edwards at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio webcast of this call, which will be accessible on the presentations/webcasts page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.



Enquiries:



GW Pharmaceuticals plc
(Today) + 44 20 7831 3113

Dr Geoffrey Guy, Chairman
(Thereafter) + 44 1980 557000

Justin Gover, Managing Director








Financial Dynamics
+ 44 20 7831 3113

Ben Atwell / John Dineen








Piper Jaffray Ltd
+44 (0)20 3142 8700

Neil Mackison / Rupert Winckler






Notes to Editors



Regulatory Process

In the decentralized procedure, issues raised by the regulatory authorities are classified in terms of their importance. At Day 150 of the procedure, unresolved "major" issues mean that the product is not approvable. If all major issues are considered resolved at Day 150, the regulators deem the product to be approvable subject to resolution of any "points for clarification". Such points are necessary to resolve prior to approval but are not considered as barriers to approvability.



MS Spasticity

There are approximately 670,000 people with MS in Europe (source: European MS Platform).Spasticity (spasms and stiffness) is one of the most common symptoms of MS occurring in as many as three quarters of people with MS. Spasticity can affect many aspects of daily life, such as walking and sitting. Sativex aims to treat high need patients who have previously failed to gain adequate benefit from currently available anti-spasticity treatments.



About Almirall

Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing. The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions. Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 11 affiliates.



About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.



This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW's 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 the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumer and medical professionals.


This information is provided by RNS
The company news service from the London Stock Exchange

END


MSCSFAFUWFSSEED

AT LAST WE'RE GETTING THERE!!!!!!!!!!!!!!!!!!!

Its been a long wait, but looking very positive now.

been holding these for 3 years and were as interesting as watching paint dry....in the money at last now