German GBA establishes positive additional benefit of Sativex® in Multiple Sclerosis Spasticity

 

German G-BA establishes positive additional benefit of Sativex® in Multiple Sclerosis Spasticity

22  June  2012

Porton Down, UK, 21 June 2012: GW Pharmaceuticals plc (AIM: GWP, “GW” or “the Group”), the specialty pharmaceutical company focused on cannabinoid science, is pleased to note the announcement from its partner Almirall that the resolution of the German Federal Joint Committee (G-BA) on the early evaluation of benefits for Sativex® has been positive.

Justin Gover, GW‘s Managing Director, said, “The determination by the G-BA that Sativex®offers additional benefit as an add on therapy in MS spasticity is a positive step for GW. We now look forward to our partners, Almirall, commencing price negotations in Germany.“

The full text of Almirall‘s announcement is below.

GW Enquiries:

FTI Consulting + 44 20 7831 3113

Simon Conway / John Dineen

Peel Hunt LLP   +44 207 418 8900

James Steel / Vijay Barathan

PRESS INFORMATION

Sativex® oromucosal spray for Multiple Sclerosis Spasticity: G-BA establishes positive additional benefit

Hamburg, 21st June 2012 – The resolution of the Federal Joint Committee (G-BA) on the early evaluation of benefits for Sativex®, an endocannabinoid system modulator, has been positive. The G-BA determined that there was an indication of minor added benefit   of Sativex® as an add-on therapy in MS-induced spasticity. This is in contrast to a previous evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG) that had certified no additional benefit of Sativex®, for technical reasons.

The G-BA has now confirmed the company’s position and certified an additional benefit to Sativex®’s use in MS Spasticity management.

 

“Firstly, we are pleased by the positive decision of the G-BA, which recognises that Sativex® has an important role to play in meeting the needs of patients with spasticity due to multiple sclerosis. Whilst the G-BA has defined the benefit as minor, we believe that Sativex® offers a substantial benefit to patients and we now look forward to the meeting with the pricing authorities as the next step in this process.” stated Farid Taha, Managing Director of Almirall Hermal GmbH.

Sativex® an innovative therapy in MS-induced spasticity

Sativex® is indicated as a supplemental treatment for patients with multiple sclerosis whose moderate to severe spasticity cannot be adequately treated with other antispasticity drugs. Spasticity can severely affect the health of patients and lead to the abandonment of day-to-day lifestyle and can require regular nursing care. In addition, these constrictions are frequently connected with severe pain and sleep disorders. The actives in Sativex® delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are able to modulate the body’s own cannabinoid system and thereby reduce spasticity.

 

All three trials related to approval showed significant benefits for treatment with Sativex®1,2,3. Practical data confirmed that approx. 50 percent of the patients with insufficiently treated MS-induced spasticity that could be considered in a trial showed a clinically relevant degree of response to Sativex®, generally within the first four weeks of treatment.

Notes to Editors

G-BA

The Federal Joint Committee (G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The G-BA is responsible for issuing reports which determine the “added value” of newly approved medicines in Germany. These reports inform subsequent pricing negotiations with the federal pricing authorities. As part of the G-BA process, the G-BA receives advisory reports from the Institute for Quality and Efficiency in Health Care (IQWIG). Following receipt of submissions from stakeholders, including IQWIG, the G-BA concludes its discussions and adopts a final directive.

Sativex®

Sativex® is an endocannabinoid-system modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol)-, which was developed and is manufactured by GW Pharmaceuticals plc, UK., Almirall holds marketing rights in Europe (except United Kingdom) and Mexico.

Sativex® is indicated as a treatment for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not adequately responded to other anti-spasticity medications and who have demonstrated a clinically significant improvement in symptoms related to spasticity during an initial treatment testing period[i]. Sativex® is effective in all types of MS, independently of the disability status (as per Expanded Disability Status Scale -EDSS-, a rating system that is frequently used for classifying and standardizing the condition of people with multiple sclerosis).[ii]

Sativex® contains active ingredients known as ‘cannabinoids’ which are extracted from the plantCannabis Sativa grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that exist naturally throughout our body, including the brain.[iii] A receptor is a site located in a brain cell in which certain substances can stick or “bind” for a while. If this happens, this binding has an effect on the cell and the nerve impulses it produces, causing a ‘dimming-down’ of the spasticity symptom. In patients who respond to Sativex®, this is the effect that improves their spasticity symptoms and helps them cope with their daily activities.[iv]

This medicine is also in Phase III clinical development as a treatment for cancer pain.

About 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), rheumatoid arthritis, multiple sclerosis, 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

Contact:

Ogilvy Healthworld GmbH 
Andrea Ammermann
Tel.: 0211/497 00-534
Mail: andrea.ammermann@ogilvy.com



REFERENCES:

1 Collin C. et al., Eur J Neurol 2007, 14, 290-296.

2 Collin C. et al., Neurol Res 2010, 32, 451-459.

3 Novotna A. et al., Eur J Neurol 2011, 18, 1122-1131.

[ii] Patient leaflet

[ii] A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis - Novotna A. et al, European Journal of Neurology 2011 – Sept ; 18(9):1122-31.

[iii] GW Pharmaceuticals: Cannabinoid Science: Mechanism of action. Available at.http://www.gwpharm.com/mechanism-of-action.aspx (latest access: 26/04/2012).

[iv] GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds. Available athttp://www.gwpharm.com/types-compounds.aspx (Last accessed: 26/04/12).