New randomized controlled study confirms the efficacy and tolerability profile of Sativex® in the treatment of multiple sclerosis spasticity resistant patients

Paris, 27th October 2017

Almirall, S.A. (ALM) announces that Prof. Markova (Thomayer Hospital, Prague, Czech Rep.), primary investigator, has presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, the top line efficacy results of a new randomized placebo controlled clinical study, SAVANT, that further confirms the efficacy and tolerability profile of Sativex® (THC:CBD oromucosal spray cannabinoid based medicine) in the treatment of multiple sclerosis (MS) resistant spasticity (muscle rigidity) for patients who have not responded to first line therapies.

SAVANT study is the first randomized clinical study with Sativex^® on multiple sclerosis resistant spasticity management since 2014. Its primary objective was to evaluate the efficacy of Sativex^® as an add-on therapy in patients with moderate to severe spasticity who had not gained adequate relief during treatment with two optimized standard antispasticity medications. Secondary objectives were to evaluate the effect of this treatment on spasticity and associated symptoms, and to further characterize its tolerability.

The results of this study demonstrate that Sativex^® is an effective and well-tolerated add-on option for treating patients with resistant multiple sclerosis spasticity, as well as burdensome associated symptoms instead of just adjusting again the first line options treatment.

191 patients entered the study, of which 106 were randomized and after 12 weeks the clinically relevant responder rate was 77.4% within the Sativex^® patients group, vs 32.1% within the placebo group (p0.0001). There were also statistically significant improvements in favour of Sativex^® at week 12 in the mean changes of the overall spasticity score, Ashworth spasticity score, and pain score.

22.6% of the Sativex^® patient group and 13.2% of the placebo patient group reported one or more mild or moderate adverse events. No serious adverse events were reported.

Almirall, a science partner

Spasticity is a common symptom in patients with multiple sclerosis which increases in severity as the disease progresses¹. It is also strongly associated with fatigue, anxiety, depression, pain, mobility and bladder problems, and adversely affects patients' health-related quality of life^1,2. Both physiotherapy and pharmacological therapies are available for treating spasticity. However, standard first-line oral antispasticity medications are often liable to undesirable adverse effects³.

"These positive results are an important milestone for Almirall as they demonstrate that we use science to offer innovative solutions to healthcare professionals so they can treat their patients better. The SAVANT study is the result of dedicated research carried out by Almirall, and confirms the efficacy of Sativex^® as the best option when first line therapies have failed", explained Bhushan Hardas, Executive Vice President R&D and Chief Scientific Officer of Almirall.

Almirall has a proven track record and important legacy on creating value through its R&D. The company has a strong focus on skin health, however, in its wide range of products and valuable pipeline there are treatment options for other diseases not related to the skin, such as multiple sclerosis.

About Sativex^®

Sativex^® is an endocannabinoid system modulator made of two active principles - 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).

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. 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)⁴.

Sativex^® contains active ingredients known as ‘cannabinoids', which are extracted from the plant C. Sativa grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that exist naturally throughout our body, including the brain⁵. A receptor is a site located in the nervous system and other systems cells in which certain substances bind causing a reaction. If this happens in cannabinoid receptors, this binding has an effect on the cell and the nerve impulses it produces, causing a reduction of spasticity symptoms. In patients who respond to Sativex^®, it is this effect that improves their spasticity symptoms and helps them cope with their daily activities⁶.

About SAVANT study

Sativex^® as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) was a prospective, parallel group, randomized, double-blind, placebo-controlled two-phase trial conducted in Europe in 2017. It included 191 patients, which were enrolled at 15 sites from Czech Republic and Austria.

The study was sponsored by Almirall Hermal GmbH and Almirall S.A.

About Almirall

Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.

The company, founded in 1943 and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenue in 2016 was 859.3 million euros and more than 2,000 employees are devoted to Science.

References:

¹ Kister I, Bacon TE, Chamot E, et al. Natural history of multiple sclerosis symptoms. Int J MS Care 2013;15:146–158.

² Milinis K, Tennant A, Young CA, et al. Spasticity in multiple sclerosis: associations with impairments and overall quality of life. Mult Scler Relat Disord 2016;5:34–39.

³ Chang E, Ghosh N, Yanni D, et al. A review of spasticity treatments: pharmacological and interventional approaches. Crit Rev Phys Rehabil Med 2013;25(1-2):11–22.

⁴A 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.

⁵GW Pharmaceuticals: Cannabinoid Science: Mechanism of action. Available at. http://www.gwpharm.com/mechanism-of-action.aspx(latest access: 26/04/2012).

⁶GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds. Available at http://www.gwpharm.com/types-compounds.aspx(Last accessed: 26/04/12).

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