Barcelona, Spain - March 14th, 2011: Almirall, S.A. (ALM) announces that Sativex® is now
available to health professionals and patients in the Spanish hospital pharmacies. It is the
first specific treatment for spasticity in MS patients who have not responded adequately to
other treatments. Sativex® is administered as oromucosal spray enabling flexible dosage,
which is particularly appropriate given the variable nature of spasticity and MS itself.
Evidence from clinical trials shows that Sativex® has a positive impact on spasticity, sleep
quality and mobility and enables patients to carry out everyday tasks such as getting up,
getting dressed or washed. This affords patients greater independence and reduces the
frequency of spasms. It is estimated that in Spain there are around 40,000 people with MS1 and up to 75% of them suffer from spasticity in the course of their disease.
Doctor Rafael Arroyo, head of the Multiple Sclerosis unit of the Department of Neurology in
Hospital Clinico San Carlos in Madrid said, “This is encouraging for patients and really
interesting news for healthcare professionals, because it provides another treatment option
for our MS patients who up to now had not been able to obtain an improvement of symptoms
such as spasticity, muscle spasms, cramps or stiffness”.
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.
Two websites and a 24h patient medical care phone service
Almirall has set up a specific website on symptoms related to MS -www.vivirconem.com- for
patients and family members or carers, which contains a variety of audiovisual content aimed
at providing a clear understanding of the specific symptoms of the disease and useful tips for
daily life. There is also a second website -www.tupuntodeapoyo.com- and a 24h telephone
medical care service to help patients follow their treatment guidelines (dose titration of
Sativex® in order to find the optimal number of daily doses). This website has restricted
access for patients to whom Sativex® has already been prescribed.
"In line with our philosophy of providing innovative solutions to patients, we are introducing in
Spain the novel medicine Sativex®, the first drug offering those affected by Multiple Sclerosis
a proven alternative to help them improve their spasticity and associated symptoms. This
launch is complemented with on-line initiatives to support and inform them about its use,
reinforcing our commitment to wellness and health", said Luciano Conde, Chief Operating
Executive of Almirall. "We also expect to launch Sativex® in other European countries later in
2011", he said.
According to the official communication from the Spanish Ministry of Health, Sativex® is
financed by the National Health System with 100% reimbursement and the product is
required to be dispensed from hospital pharmacies for outpatients.
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).
For more information:
GW Pharmaceuticals plc
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Today: +44 20 7831 3113
Thereafter: +44 1980 557000
Peel Hunt LLP (Nominated Adviser)
44 (0) 20 7418 8900
44 (0) 20 7831 3113
Sativex® is an endocannabinoid 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).
Sativex® is indicated as an add-on 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 period2
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 brain. 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.
In the five main EU markets there are around 500,000 people suffering from MS 5 and in Spain around 40,000 cases of the disease have been reported. Spasticity is a symptom defined by patients and carers as muscle spasms, seizing-up, stiffness and/or difficulty in moving muscles and it is one of the most common symptoms of MS, occurring in up to 75% of MS sufferers in the course of the disease. Spasticity can affect many aspects of the daily lives of patients with MS and is one of the main factors contributing to their distress and disability.
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
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
About 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 visit www.gwpharm.com
FELEM (Spanish Federation for the fight against Multiple Sclerosis): reality, social needs and quality of life.
GW Pharmaceuticals: Cannabinoid Science: Mechanism of action. Available at.
http://www.gwpharm.com/mechanism-of-action.aspx (latest access: 11/08/2010).
GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds. Available at
http://www.gwpharm.com/types-compounds.aspx (Last accessed: 01/07/10).
Multiple Sclerosis International Federation: European map of ms database. ©
2010 EMSP, MSIF. Available at:
www.europeanmapofms.org (latest access: 11/08/2010). Top five EU countries include: France, Germany, Italy,
Spain and UK.
Rizzo MA et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler