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RNS Number : 8336C
GW Pharmaceuticals PLC
14 March 2011
GW Pharmaceuticals PLC ("GW Pharmaceuticals" or the
"Company")
Sativex(R) launched in Spain
Porton Down, UK, 14 March 2011: GW Pharmaceuticals (AIM: GWP) is
pleased to announce that Sativex(R) has today been launched in
Spain by GW's marketing partner Almirall, S.A. (ALM).
Under the terms of its licence agreement with Almirall, GW will
now receive a GBP2.5m milestone payment in respect of the
commercial launch of Sativex(R) in Spain.
Sativex(R) was granted reimbursement in Spain by the Spanish
Ministry of Health in February.
The full text of the announcement by Almirall follows.
Sativex(R) launched in Spain to treat spasticity
in multiple sclerosis (MS)
-- 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
-- Almirall is also launching a website for patients, carers and
family members to provide information on symptoms associated with
MS and a 24h medical care phone service
Barcelona, Spain - March 14(th) , 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 itself.
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
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(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).
- Ends -
For more information:
GW Pharmaceuticals plc
Dr Geoffrey Guy, Chairman Today: +44 20 7831 3113
Justin Gover, Managing Director Thereafter: +44 1980 557000
Peel Hunt LLP (Nominated Adviser)
James Steel
Vijay Barathan +44 (0) 20 7418 8900
Financial Dynamics
Ben Atwell
John Dineen + 44 (0) 20 7831 3113
Notes to Editors
Sativex(R)
Sativex(R) 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(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 activities.(4)
Spasticity
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
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
Bibliography
(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.
http://www.gwpharm.com/mechanism-of-action.aspx (latest access:
11/08/2010).
(4 ) GW Pharmaceuticals: Cannabinoid Science: Cannabinoid
Compounds. Available at http://www.gwpharm.com/types-compounds.aspx
(Last accessed: 01/07/10).
(5) Multiple Sclerosis International Federation: European map of
ms database. (c) 2010 EMSP, MSIF. Available at:
www.europeanmapofms.org (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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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