Sativex(R) Launched in Spain to Treat Spasticity in Multiple Sclerosis (MS)

By Almirall, PRNE
Sunday, March 13, 2011

Sativex(R) is Available From Today in Spain. The Approved Indication is Treatment of Spasticity due to MS in Patients not Responding to Other Therapies

BARCELONA, March 14, 2011 - Almirall, S.A. (ALM) announces that Sativex(R) 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(R) is
administered as oromucosal spray enabling flexible dosage, which is
particularly appropriate given the variable nature of spasticity and MS

Evidence from clinical trials shows that Sativex(R) 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
MS[1] and up to 75% of them suffer from spasticity in the course of their

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

Two websites and a 24h patient medical care phone service

Almirall has set up a specific website on symptoms related to
MS 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 and a 24h
telephone medical care service to help patients follow their treatment
guidelines (dose titration of Sativex(R) in order to find the optimal number
of daily doses). This website has restricted access for patients to whom
Sativex(R) has already been prescribed.

"In line with our philosophy of providing innovative solutions
to patients, we are introducing in Spain the novel medicine Sativex(R), 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(R)
in other European countries later in 2011," he said.

According to the official communication from the Spanish
Ministry of Health, Sativex(R) is financed by the National Health System with
100% reimbursement and the product is required to be dispensed from hospital
pharmacies for outpatients.

Sativex(R), 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).

Notes to Editors


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

Sativex(R) 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 period[2].

Sativex(R) 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.[3] 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(R), this is the effect
that improves their spasticity symptoms and helps them cope with their daily


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.[1] 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.[6]

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

For further information please visit the website at:


[1] FELEM (Spanish Federation for the fight against Multiple Sclerosis):
reality, social needs and quality of life. 2005-2006.

[2] Patient leaflet

[3] GW Pharmaceuticals: Cannabinoid Science: Mechanism of action.
Available at. (latest access:

[4] GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds.
Available at (Last accessed:

[5] Multiple Sclerosis International Federation: European map of ms
database. (c)2010 EMSP, MSIF. Available at: (latest
access: 11/08/2010). Top five EU countries include: France, Germany, Italy,
Spain and UK.

[6] Rizzo MA et al. Prevalence and treatment of spasticity reported by
multiple sclerosis patients. Mult Scler 2004;10:589-595.

Contact: Emanate, Fiona Gildea, Tel. +44-(0)20-7611-3881, fiona.gildea at

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