Regulatory Approval (9660E)
April 15 2011 - 2:00AM
UK Regulatory
TIDMGWP
RNS Number : 9660E
GW Pharmaceuticals PLC
15 April 2011
Sativex(R) Approved in the Czech Republic
Porton Down, UK; 15 April 2011: GW Pharmaceuticals plc (AIM:GWP)
today announces that Sativex(R) oromucosal spray has been approved
in the Czech Republic as a treatment for spasticity due to Multiple
Sclerosis (MS).
This approval follows GW's announcement on 22(nd) March 2011
that the European Mutual Recognition Procedure had successfully
completed with all six countries involved recommending approval.
The countries involved in the MRP were Germany, Italy, Denmark,
Sweden, Austria and the Czech Republic. The Czech Republic is the
first of these countries to approve Sativex. The remaining
countries involved in the MRP are expected to approve Sativex in
the coming months.
Launch timing in each country will be dependent on national
regulations concerning pricing and reimbursement. In accordance
with previous guidance, GW's marketing partner, Almirall S.A.,
anticipates launch in Germany, Denmark and Sweden before the end of
2011 with the remaining countries, including the Czech Republic,
expected in 2012.
Sativex(R) is also in phase III clinical development for the
treatment of cancer pain, Almirall holds the marketing rights to
this medicine in Europe (except the United Kingdom).
Enquiries:
GW Pharmaceuticals plc (Today) + 44 20 7831 3113
(Thereafter) + 44 1980
Dr Geoffrey Guy, Chairman 557000
Justin Gover, Managing Director
Financial Dynamics + 44 20 7831 3113
Ben Atwell / John Dineen
Peel Hunt LLP +44 (0)20 7418 8900
James Steel / Vijay Barathan
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(I) .
Sativex(R) contains active ingredients known as 'cannabinoids'
which are extracted from the plant Cannabis Sativa grown and
processed under strictly controlled conditions. Cannabinoids react
with cannabinoid receptors that exist naturally throughout our
body, including the brain.(II) 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.(III)
Spasticity
In the five main EU markets there are around 500,000 people
suffering from MS (IV) 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.(V)
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
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
development and regulatory clearance of the GW's products.
Forward-looking statements involve risks and uncertainties. Actual
events could differ materially from those projected herein and
depend on a number of factors, including (inter alia), the success
of the GW's research strategies, the applicability of the
discoveries made therein, the successful and timely completion of
uncertainties related to the regulatory process, and the acceptance
of Sativex(R) and other products by consumer and medical
professionals.
GW Pharmaceuticals: Cannabinoid Science: Mechanism of action.
Available at. http://www.gwpharm.com/mechanism-of-action.aspx
(latest access: 11/08/2010).
I Patient leaflet
II GW Pharmaceuticals: Cannabinoid Science: Mechanism of action.
Available at. http://www.gwpharm.com/mechanism-of-action.aspx
(latest access: 11/08/2010).
III GW Pharmaceuticals: Cannabinoid Science: Cannabinoid
Compounds. Available at http://www.gwpharm.com/types-compounds.aspx
(Last accessed: 01/07/10).
IV 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.
V 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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