Sativex® launched in Germany

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Jul 04, 2011

Porton Down, UK; 4 July 2011: GW Pharmaceuticals plc (AIM:GWP) today announces the launch in Germany of Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as a treatment of spasticity due to Multiple Sclerosis (MS). This launch follows regulatory approval of Sativex® by the German health authorities in May. Germany has the highest prevalence of MS in Europe.

Sativex® is a first in class endocannabinoid system modulator and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). Sativex® offers the first new therapeutic option in decades to patients in Germany who have previously failed to respond adequately to other anti-spasticity medication. The spray is quickly absorbed through the oral mucosa, is easy to use for patients and enables them to optimally adjust their dosage. The medicine is already available for MS patients in the UK and Spain.

Spasticity (otherwise known as muscle stiffness) is a common symptom of MS affecting about 80% of the 130,000 MS patients in Germany. Spasticity has a negative impact on patients’ daily lives, affecting their mobility, physical capabilities and thus their overall quality of lifei. Spasticity often leads to patients having to modify or give up certain activities and to the need for help from a family member or carer. If not treated adequately, spasticity can have long term effects and complicate treatment of other symptoms.

“Spasticity in multiple sclerosis can have a significant negative impact on patients’ daily lives. In particular, muscle cramps and stiffness are usually very painful and can disturb sleep. This new medication is therefore a highly promising treatment option for both neurologists and patients”, said Prof. Dr. med. Juergen Koehler, Managing Director and Medical Head of the MS Treatment Center, Kempfenhausen.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in MS, while alleviating associated symptoms. The relief of symptoms and positive impact on sleep quality and mobility enables patients to better cope with everyday tasks.

“Almirall’s philosophy is to provide innovative solutions for patients. This first new medication for treating spasticity in multiple sclerosis offers an important new treatment option to help multiple sclerosis patients improve their spasticity and associated symptoms”, said Farid Taha, Managing Director, Almirall, Germany, Austria and Switzerland.

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 brainsii. A 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 activitiesiii.

In addition to Germany, Almirall also expects to launch Sativex® in Denmark and Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.

Sativex® is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Sativex® was developed by GW Pharmaceuticals. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Enquiries:

GW Pharmaceuticals plc (Today) + 44 20 7831 3113
Dr Geoffrey Guy, Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director 

GW PR: Financial Dynamics + 44 20 7831 3113
Ben Atwell / John Dineen

GW Nominated Adviser: Peel Hunt LLP +44 (0)20 7418 8900
James Steel / Vijay Barathan 

Notes to Editors

Sativex®
Sativex® was developed by UK-based GW Pharmaceuticals plc in specific response to the MS population’s unmet need for a prescription cannabis-based medicine. Manufactured under Home Office licence at an undisclosed location in the UK it will be marketed in Europe (except the UK) by Almirall.

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. Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.

GW Pharmaceuticals
GW Pharmaceuticals plc (AIM:GWP) 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 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.

References

i   DMSG,www.dmsg.de, (Latest access: 6.05.2011)

ii  GW Pharmaceuticals. Cannabinoid Science: Mechanism of action. Available athttp://www.gwpharm.com/mechanism-of-action.aspx(Last accessed: 01/05/11).
iii GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available athttp://www.gwpharm.com/types-compounds.aspx(Last accessed: 01/05/11).

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