Sativex® approved in Germany for the treatment of spasticity due to Multiple Sclerosis

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May 26, 2011

Barcelona, Spain and Porton Down, UK; 26th May 2011: Almirall, S.A. (ALM) and GW Pharmaceuticals plc (AIM:GWP) today announce that the health authorities in Germany have granted regulatory approval for Sativex®(Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to Multiple Sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medicationi. Sativex®is expected to be launched in Germany in July 2011.

Sativex®is a first in class endocannabinoid system modulator for the treatment of spasticity in MS and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). The medicine is already available for MS patients in the UK and Spain.

Spasticity (otherwise known as muscle stiffness) has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleep. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments.

Evidence generated from clinical trials shows that Sativex®has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder and sleep disturbance.

Approval in Germany follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all six countries involved recommending approval. These countries were Germany, Denmark, Sweden, Italy, Czech Republic and Austria. In addition to Germany, launch is also expected before the end of 2011 in Denmark and Sweden. Launches in Italy, Czech Republic and Austria are expected in 2012.

A further MRP submission is expected to be made later in 2011 with a view to expanding the approval of Sativex®to additional European countries.

Justin Gover, Managing Director of GW, said, “Having recently successfully launched Sativex® in Spain, we are very pleased to have now received regulatory approval in Germany. Germany has the largest MS population in Europe and we look forward to offering people with MS in Germany the opportunity to benefit from Sativex®as a new first in class treatment to treat their spasticity.”

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

Enquiries:
Almirall PR
Fiona Gildea -fiona.gildea@emanatepr.com
+44 (0)20 7611 3881 

GW PR

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.

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.

Spasticity
There are almost 500,000 people suffering of MS in the top five EU countriesiv, and 130,000 of them are reported to live with the condition in Germanyv.  Spasticity (otherwise known as muscle stiffness) is one of the most common symptoms of MS, occurring in as many as 75% of people with MS and has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleepvi. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments

Almirall
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.

Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, psoriasis and other dermatological conditions. Almirall’s products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.

For further information please visit the website at:www.almirall.com

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 Sativex® Summary of Product Characteristics, 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).

iv 2010 EMSP, MSIF,www.europeanmapofms.org, 16/06/2010. Top five EU countries include: France, Germany, Italy, Spain and UK.

v DMSG,www.dmsg.de, (Letzter Zugriff: 6.05.2011)

vi Prevalence and treatment of spasticity reported by multiple sclerosis patients – MA Rizzo et al – Multiple Sclerosis 2004; 10:589-595.

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