GW Files Sativex Regulatory Submission
May 20 2009 - 2:01AM
UK Regulatory
TIDMGWP
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 |
+--------------------------------------------+------------------------------+
| Justin Gover, Managing Director | |
+--------------------------------------------+------------------------------+
| | |
+--------------------------------------------+------------------------------+
| Financial Dynamics | + 44 20 7831 3113 |
+--------------------------------------------+------------------------------+
| Ben Atwell / John Dineen | |
+--------------------------------------------+------------------------------+
| | |
+--------------------------------------------+------------------------------+
| Investec Bank plc | + 44 20 7597 4000 |
+--------------------------------------------+------------------------------+
| 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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