Almirall presents new data from large European studies consolidating the effectiveness, safety and tolerability of Sativex® in patients with spasticity symptoms in Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic nervous system disease which affects more than 2 million patients worldwide

· Almost 600.000 European patients with MS suffer from spasticity, one of the most common MS symptoms causing stiffness, involuntary muscle spasms and other associated symptoms, and resulting in a high impact in their quality of life

· Sativex®, oromucosal spray with balanced amounts of tetrahydrocannabinol and cannabidiol, and is the only medicine derived from cannabinoids to treat MS spasticity symptoms

· In daily clinical practice, more than 60% of patients continued treatment after 1st month trial period after proving enough effect and acceptable tolerability.

Barcelona, 09th October 2015

Almirall, the global pharmaceutical company based in Barcelona, presented new clinical evidences of Sativex®, the only medicine derived from cannabinoids to treat spasticity symptoms in MS, within the context of the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in Barcelona from 7 to 10th of October. In the context of this congress, experts have discussed the different aspects of the disease, including spasticity impact on patients quality of life and the specifics of its treatment with Sativex®.

MS affects over 2 million people worldwide 130,000 in Germany, 80,000 in France, 70,000 in Italy and 45,000 in Spain.1,2 In Europe, there are more than half a million (700,000)1,2 MS patients with spasticity, which is one of the most common symptoms, and will appear in more than 80% of the MS patients across their disease evolution, resulting in a progressive and frequently painful stiffness in the muscles that prevents patients from performing everyday movements; walk with normality or rest, which generates a high impact in their quality of life.

From the about 80% of MS patients suffering from spasticity, in 1/3 of them it is moderate to severe despite classic treatment options (Rizzo 2004)3. Although many medical and health resources are expended on the medical care of these patients, including treatments and the rehabilitation they need, only half of them receive specific spasticity drug therapy.3

“Sativex® large studies presented today show new supportive evidence in clinical practice on the effectiveness and tolerability of Sativex® as the first cannabinoid based treatment for resistant spasticity in all types of MS”, confirmed Professor Maria Trojano, Professor of Neurology and Head of the Department of Basic Medical Sciences Neuroscience and Sensory Organs at the University of Bari in Italy.

Professor Trojano also said: “Sativex® inhibits the anomalous nerve impulses that cause rigidity and muscle spasms providing effective relief in spasticity and associated symptoms with an acceptable tolerability profile. Patients can experience improvement in their MS Spasticity related symptoms in a safe way and thereby benefit from an increased quality of life”.

Daily practice evidence in MS spasticity management

Sativex® is the first prescription medicine based on cannabinoids, active ingredients tetrahydrocannabinol (THC) and cannabidiol (CBD) extracted from the Cannabis sativa plant, an add-on therapy indicated to treat symptoms of moderate or severe spasticity in people with multiple sclerosis who are not responding to other antispastic treatments8.

During this year’s ECTRIMS Congress, new THC:CBD observational study data and THC:CBD in daily practice was presented, including the largest observational study to date aimed at evaluating Sativex® general effectiveness and tolerability. The Sativex® AIFA e-Registry, carried out with a large population of 1,534 Italian patients with MS, showed a high initial response rate, as more than 60% of patients continued treatment after the 1st month trial period once proving enough effect (>20% spasticity improvement from baseline) and acceptable tolerability. About 25% of these patients already showed NRS (Numeric Rating Scale) improvement over 30%. It also showed a clinically relevant effectiveness rate after 6 months, when 40.2% of them reached NRS improvements over 30% at 6 months.

Other of the relevant studies presented during this Congress had the objective to assess the effect of THC:CBD spray on MS spasticity directly recording the stretch reflex after one month of treatment. The significant reduction (56%) of the stretch reflex during the therapy shows its efficacy on symptoms related to spasticity and spasticity itself 4.

“It is important to remark on the difference between Sativex® and herbal cannabis: Sativex® is a unique cannabinoid based medicine, which has followed the appropriate R&D and regulatory processes so it is an approved prescription drug supported by proper pre-clinical and clinical studies results. In contrast, recreational cannabis, with over 60 different cannabinoids in it, lacks standarisation, the concentration of each cannabinoid is unpredictable and its use has relevant risks and legal implications”, reminded the Spanish Professor Rafael Maldonado, Director of the Neuropharmacology Laboratory, University Pompeu Fabra, in Barcelona. “The basic most common component of modern herbal cannabis is TCH, which causes psychoactive effects, known as ‘high’, and important tolerability issues, including abuse and addiction risks.

In this way, Professor Maldonado highlighted: “The main barriers to use herbal cannabis as a medicine are its relevant psychoactive effects. In the case of Sativex® the product is well characterized and the selected two active principles (THC and CBD) are present in very constant and balanced amounts after controlled pharmaceutical production. This makes the drug safe and minimizes the possible side effect such as the risk of addiction or psychotropic effects.”

Spasticity in Multiple Sclerosis: impact in patients

Multiple sclerosis is a chronic progressive neurodegenerative disease in which the immune system attacks the myelin, a substance that surrounds and insulates the neurons so the neuronal electrical impulses sent by the brain can be properly transmitted.5, 6

MS has a genetic component7 but it is not just hereditary, moreover, despite many people could think, it is neither contagious nor preventable. It appears most often between 20 and 40 years of age and is twice as common in women as in men. It is the most common neurological disorder among young adults.

The main symptoms of multiple sclerosis are balance and coordination difficulties, cognitive disorders, sensitivity disorders, loss of sphincter control, visual disturbances, pain and spasticity, which is one of the most common symptoms and is the medical term used for stiffness and involuntary muscle spasms.

Eight out of ten (80%) people with MS will suffer from spasticity, which involves that any movement or actions, which under normal conditions is performed automatically, almost without thinking, needs to be programmed consciously, because the muscles do not respond easily to nerve signals and when they do, they do not provide the expected response.3

“Symptoms related to spasticity adversely affect the quality of life of patients, as they reduce their capacity to conduct daily activities and frequently affect their already damaged mobility, bladder function, tiredness and quality of sleep. Multiple Sclerosis has not only physical consequences but also an emotional and social impact as it also affects patient’s parents, family, friends and their whole environment”, Mrs. Heike Borchert, MS-Nurse NeuroCentrum Science in Germany, explained.

In addition to muscle stiffness and involuntary spasms, in most of affected patients spasticity causes motor clumsiness and difficulty in initiating movements, whether precision movements, such as inserting a key in a lock or moving a cup towards their lips, or more global movements, such as walking, standing firm or recovering their balance after stumbling.

Furthermore, 66% of patients with spasticity experience related pain, 70% suffer from related night incontinence, half are unable to sleep well because of it and 17% need some kind of assistance to dress and clean themselves following the spasticity burden.5“

About Almirall

Almirall is a global company based in Barcelona dedicated to providing valuable medicines and medical devices through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated growth allows us to devote our talent and efforts towards specialty areas and particularly to further grow as a leading Dermatology player. Our size enables us to be agile and flexible so that we can accomplish the purpose of taking our innovative products wherever they are needed.

Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2014, its revenues totaled 1,407 million euros and, with more than 2,100 employees, it has gradually built up a trusted presence across Europe, as well as in the US and Mexico.

For more information, please visit www.almirall.com