GWP GW Pharm.

 

TIDMGWP 
 
RNS Number : 6943O 
GW Pharmaceuticals PLC 
11 March 2009 
 

 
 
GW REPORTS HIGHLY STATISTICALLY SIGNIFICANT RESULTS IN SATIVEX  PIVOTAL PHASE 
III STUDY IN MS SPASTICITY 
 
 
Expected Milestone Payment from Almirall of GBP8m 
 
 
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 GBP8m. The GBP8m 
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 GBP10m milestone payment from Bayer. On approval in Spain, GW will 
receive a further GBP2.5m 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 
 

Gw Pharmaceuticals (LSE:GWP)
Historical Stock Chart
From Jun 2024 to Jul 2024

Gw Pharmaceuticals (LSE:GWP)
Historical Stock Chart
From Jul 2023 to Jul 2024