Sativex Approved in New Zealand for the Treatment of Spasticity due to Multiple Sclerosis

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Nov 03, 2010

Porton Down, UK, 3 November 2010: GW Pharmaceuticals plc (AIM: GWP) today announces that the New Zealand regulatory authority, MedSafe, has approved Sativex® as a treatment for the relief of spasticity in Multiple Sclerosis (MS).

Sativex®contains two cannabinoids or active ingredients - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) and is administered as a mouth spray.  It is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant.

A consent notice to distribute Sativex®under Section 20 of the Medicines Act 1981 has been published in the New Zealand Gazette, the official newspaper of the Government of New Zealand.

Dr Stephen Wright, R&D Director, said, “New Zealand represents the fourth approval for Sativex®in recent months and follows approvals in the UK, Spain and Canada. We are delighted that Sativex has received positive endorsement from another of the world’s most highly regarded regulatory authorities.”

Sativex®is currently licensed to marketing partners in both Europe and North America. GW will appoint a commercial partner for New Zealand as part of a wider strategy to put in place distributors for regions of the world which are not yet partnered. The commercial plan for New Zealand will be determined in due course in collaboration with the distributor for that country when an agreement is in place.

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
Ben Atwell / John Dineen 

Piper Jaffray Ltd +44 (0)20 3142 8700
Neil Mackison / Rupert Winckler

About MS
Multiple sclerosis (MS) is a degenerative neurological condition, which is associated with a wide range of distressing and disabling signs and symptoms. MS is the most common disabling disease of the CNS affecting young adults and is usually diagnosed between the ages of 20 and 40 years.1,2MS is twice as common in women than in men.1,2An estimated 3,000 people in New Zealand have MS.3

About spasticity
Spasticity is a common symptom associated with Multiple Sclerosis (MS)4and is a major contributor to disability.5It is caused by damage to the nerves in the central nervous system which carry messages instructing muscles how to move resulting in an involuntary muscle overactivity.6

In a survey, 84% of people with MS reported symptoms of spasticity.7Moderate, severe or total spasticity is reported in 34% of individuals.7Symptoms include loss of mobility, painful spasms, stiffness and / or weakness of muscles.6As a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement.4In addition to causing a great deal of distress to the person with MS, mood, self-image and motivation can also be affected.8

About Sativex®
Sativex®was developed by GW Pharmaceuticals plc in specific response to the MS population’s unmet need for a prescription cannabis based medicine and is manufactured under Home Office licence at an undisclosed location in the UK,

Sativex® is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.9

Sativex® contains active ingredients called ‘cannabinoids’, which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains.10A receptor is a site on a brain cell where certain substances can stick or “bind” for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a ‘dimming down’ of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.11

Sativex®is primarily made up of a 1:1 ratio of two particular cannabinoids - cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).12The CBD:THC formulation is believed to provide a good balance of clinical effect - a significant decrease in MS spasticity- to  THC-related side effects.11,12

Main effects of CBD and THC:11
CBD:
Anti-inflammatory, anticonvulsant, antipsycotic, anti-oxidant, neuroprotective, immunomodulatory

THC:
Analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant, anti-emetic

The most common side effects of Sativex® are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued.9

Sativex®is a registered trade mark of GW Pharmaceuticals. Health Support, a New Zealand-based contract research organization currently act as local agents on behalf of GW Pharmaceuticals.

About GW Pharmaceuticals

GW was founded in 1998 and is listed on the AiM, a market of the London Stock Exchange.  Operating under licence 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 MS 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.

For further information, please visitwww.gwpharm.com

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.

1. Multiple Sclerosis Trust. MS Explained. 2008. Available athttp://www.mstrust.org.uk/information/publications/msexplained/
2. NHS Choices. Multiple Sclerosis Introduction. Available athttp://www.nhs.uk/conditions/multiple-sclerosis/pages/introduction.aspx
3. http://www.mult-sclerosis.org/prev_tab.html
4. Multiple Sclerosis Trust. Multiple Sclerosis Information for Health and Social Care Professionals. 2007. Available athttp://www.mstrust.org.uk/downloads/ms_information_for_hps.pdf
5. Beard S, et al. Health Technol Assess 2003;7(40)
6. Multiple Sclerosis Trust. Spasticity and Spasms factsheet. November 2009
7. Rizzo MA, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Multiple Sclerosis 2004;10:589/595
8. Multiple Sclerosis International Federation. Spasticity in MS. MS in focus. Issue 12. 2008. Available athttp://www.msif.org/docs/MSinFocusIssue12EN.pdf
9. Sativex® New Zealand Datasheet, 2010
10. GW Pharmaceuticals. Cannabinoid Science: Mechanism of action. Available athttp://www.gwpharm.com/mechanism-of-action.aspx
11. GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available athttp://www.gwpharm.com/types-compounds.aspx
12. GW Pharmaceuticals. Frequently Asked Questions. Available athttp://www.gwpharm.com/sativex-faqs.aspx

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