GW Files Sativex Regulatory Submission

 

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RNS Number : 5306S 
GW Pharmaceuticals PLC 
20 May 2009 
 

GW FILES SATIVEX  REGULATORY SUBMISSION 
 
 
Porton Down, UK, 20 May 2009: GW Pharmaceuticals plc (GWP:AIM) today announces 
that it has filed a regulatory submission for Sativexfor the treatment of 
spasticity due to Multiple Sclerosis. This submission follows the recent 
announcement of a positive Phase III trial in this indication. 
 
 
The regulatory submission has been filed in the UK and Spain under the European 
decentralised procedure. The UK regulatory authority, the Medicines and 
Healthcare products Regulatory Agency (MHRA), is acting as 
Reference Member State and has validated the application. 
 
 
It is expected that an outcome of the regulatory submission will be known 
towards the end of 2009 / early 2010. 
 
 
Following approval in the UK and Spain, submissions for approval will made in 
additional European countries during 2010 under the mutual recognition 
procedure. 
 
 
Sativex will be marketed in the UK by Bayer HealthCare, and in the rest of the 
European Union by Laboratorios Almirall S.A. 
 
 
Dr Stephen Wright, GW's R&D Director, said, "We are pleased to have completed 
and filed the regulatory submission within a very short period of time of 
receiving the latest positive Phase III data. We look forward to working with 
the regulatory authorities in their review of the application." 
Enquiries: 
 
 
+--------------------------------------------+------------------------------+ 
| GW Pharmaceuticals plc                     |    (Today) + 44 20 7831 3113 | 
+--------------------------------------------+------------------------------+ 
| Dr Geoffrey Guy, Chairman                  |       (Thereafter) + 44 1980 | 
|                                            |                       557000 | 
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| Justin Gover, Managing Director            |                              | 
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|                                            |                              | 
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| Financial Dynamics                         |            + 44 20 7831 3113 | 
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| Ben Atwell / John Dineen                   |                              | 
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|                                            |                              | 
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| Investec Bank plc                          |            + 44 20 7597 4000 | 
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| Patrick Robb                               |                              | 
+--------------------------------------------+------------------------------+ 
 
 
Notes to Editors 
 
 
MS Spasticity 
There are approximately 500,000 people with MS in Europe. 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. 
 
 
Sativex Phase III Trial 
On 11 March 2009, GW announced 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. 
 
 
The prospectively defined primary efficacy endpoint of the study - the 
difference between the mean change in spasticity severity of Sativex vs Placebo 
- was highly statistically significantly in favour of Sativex (p=0.0002). The 
difference between Sativex and placebo was also highly significant for a number 
of secondary endpoints, including the 30% responder analysis (p=0.0003), 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). 
 
 
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 21 countries around 
the world. 
 
 
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 
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