Sativex granted reimbursement in Spain (3795B)
February 17 2011 - 2:00AM
UK Regulatory
TIDMGWP
RNS Number : 3795B
GW Pharmaceuticals PLC
17 February 2011
GW Pharmaceuticals PLC ("GW Pharmaceuticals" or the
"Company")
Sativex(R) granted reimbursement in Spain
Porton Down, UK, 17 February 2011: GW Pharmaceuticals (AIM: GWP)
is pleased to announce that Sativex(R) has been granted national
reimbursement in Spain from the Spanish Ministry of Health.
Sativex(R) is expected to be launched shortly in Spain by GW's
marketing partner Almirall, S.A. (ALM). The full text of the
release from Almirall follows below.
Sativex(R) granted reimbursement in Spain, for the treatment of
spasticity in multiple sclerosis
-- This is the first specific treatment for spasticity associated with
multiple sclerosis (MS) which will be available in the Spanish hospital
pharmacies shortly
-- Approval of Sativex(R) in additional EU member states is expected in
2011
Barcelona, February 16(th) , 2011: Almirall, S.A. (ALM)
announces that the Spanish Ministry of Health granted the
reimbursement of Sativex(R) in Spain, as confirmed by the Spanish
Ministry of Health. It is the first treatment specifically designed
for patients with MS-related spasticity who have not responded to
other treatments. Sativex(R) is administered as an oral spray,
enabling flexible dosage, which is particularly appropriate given
the variable nature of spasticity and MS itself.
The approval of Sativex(R) in additional EU member states is
expected in 2011.
It is estimated that there are around 40,000 people suffering
from MS in Spain(1) of whom around 75% suffer from spasticity, a
painful and debilitating disorder that causes stiffness in muscles,
painful cramps and sudden uncontrolled movements in limbs (spasms)
that increase tiredness and reduced mobility. Even daily activities
such as unscrewing a bottle top or getting out of bed can become
difficult, affecting the patients' quality of life and state of
mind.(2)
Sativex(R) is an endocannabinoid system modulator made up
principally of two active ingredients -THC
(delta-9-tetrahydrocannabinol) and CBD (cannabidiol)-, and
developed by GW Pharmaceuticals (UK). The Phase III programme for
Sativex(R) in cancer pain started late 2010.
Almirall, S.A. has the marketing rights in Europe (except the
UK).
This is the first prescription medicine approved in Spain
derived from cannabis and will be available with full reimbursement
to MS patients in hospitals.
For more information:
GW Pharmaceuticals plc Today: +44 20 7831
Dr Geoffrey Guy, Chairman 3113
Justin Gover, Managing Director Thereafter: + 44 1980557000
Peel Hunt Limited (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) was developed by GW Pharmaceuticals plc, United
Kingdom as a specific response to unmet needs of the population
suffering from MS. The medicine is manufactured in the United
Kingdom and Almirall holds marketing rights in Europe (except
United Kingdom).
Sativex(R) is indicated as an add-on treatment for patients with
moderate to serious spasticity due to multiple sclerosis (MS) who
have not adequately benefitted from other anti-spasticity
medications and who have demonstrated a clinically significant
improvement in symptoms related to spasticity during an initial
treatment testing period.(2)
Spasticity
Spasticity or muscle stiffness is one of the most common
symptoms of MS, affecting around 80% of patients with MS. It has a
negative impact on their daily lives, as muscle stiffness reduces
their ability to perform daily activities such as walking, keeping
upright, movement in general or bowel function (bladder), as well
as causing sleep problems.
If spasticity is not properly controlled, these patients'
quality of life is greatly affected. They are forced to modify or
abandon certain activities and often require help from a family
member or carer.
In the five most important markets in the EU there are around
500,000 people suffering from MS and 40,000 cases of the disease
have been diagnosed in Spain.(1)
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) Atlas of MS database (http://www.atlasofms.org/)- MSIF.
Latest update 2008.
(2) Multiple Sclerosis International Federation. Spasticity in
MS. MS in focus. Issue 12. 2008. Available at:
http://www.msif.org/docs/MSinFocusIssue12EN.pdf (latest access:
11/08/2010).
This information is provided by RNS
The company news service from the London Stock Exchange
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