UK Launch of First Prescription Cannabis-Medicine
21 June 2010 - 4:00PM
UK Regulatory
TIDMGWP
RNS Number : 9123N
GW Pharmaceuticals PLC
21 June 2010
GW ANNOUNCEs UK LAUNCH OF world's first prescription cannabis-medicine
Sativex marketed to treat spasticity associated with Multiple Sclerosis
Porton Down, UK, 21 June 2010: GW Pharmaceuticals plc (GWP:AIM) today announces
the UK launch of Sativex , its Oromucosal Spray for the treatment of spasticity
due to Multiple Sclerosis (MS). Sativex is the world's first prescription
cannabis medicine and the UK is the first country in the world to grant a full
regulatory authorization for the product.
Sativex contains two cannabinoids or active ingredients - THC
(delta-9-tetrahydrocannabinol) and CBD (cannabidiol). It is the first
cannabinoid medicine derived from whole plant extracts from the cannabis sativa
plant.
Sativex , available as a prescription only medicine, was developed by GW in
specific response to calls from people with MS for a prescription cannabis-based
medicine. Today's launch means that MS patients suffering the spasms and
cramping associated with spasticity have access to a new treatment option which
has been shown to improve their symptoms where current treatments have failed.
Sativex is manufactured by GW under Home Office licence at an undisclosed
location in the UK. The medicine is being marketed in the UK by GW's UK
licensee, Bayer Schering Pharma.
Dr Geoffrey Guy, GW's Chairman, said: "The approval and launch of Sativex in
the UK is the world's first full approval of a cannabis-derived prescription
medicine and the product of eleven year's research by GW into the cannabinoid
system. GW was founded with the primary goal of developing a medicine to
address the unmet needs of people with MS and today's launch of Sativex
represents a welcome advance in MS symptom treatment. This is also an historic
moment for GW and marks the beginning of the company's transition from late
stage development company to a commercial pharmaceutical business. Today's news
validates our cannabinoid technology platform and enables us to progress the
development of our pipeline across a range of therapeutic areas with increased
confidence."
Under the terms of the agreement with Bayer, GW will receive a GBP10m milestone
payment in respect of the UK approval of Sativex .
Outside the UK, Sativex is expected to be approved in Spain shortly. Further
submissions will be made in additional European countries during the second half
of 2010 under the mutual recognition procedure. Almirall S.A. will market
Sativex in Europe (ex-UK).
The full text of a statement issued today by Bayer Schering Pharma follows
below:
Sativex launched in UK for the treatment of spasticity due to Multiple
Sclerosis
Newbury, Berkshire, 21st June 2010 - Sativex (delta-9-tetrahydrocannabinol
(THC) and cannabidiol (CBD)), the first cannabinoid medicine derived from whole
plant extracts from the cannabis sativa plant, is launched today to treat
spasticity associated with Multiple Sclerosis (MS) by Bayer Schering Pharma.1
Available as a prescription only medicine and given as a mouth spray, the launch
of Sativex means that now, for people with MS experiencing the spasms and
cramping associated with spasticity, there is another option to add to their
standard treatment.
There are approximately 100,000 people with MS in the UK and spasticity is very
common, affecting most people with the condition at some point.2,3 It causes
uncontrollable stiffness, muscle tension and spasms,4 which are often extremely
painful and immobilising. Simple day to day activities that people take for
granted like unscrewing the lid off a milk bottle or being able to get out of a
car can become very difficult. Not only does this cause people with MS huge
distress, quality of life, self-image and mood can be greatly affected.4
Speaking about the availability of Sativex , Pam Macfarlane, Chief Executive of
the MS Trust said, 'We have been aware for a long time, based on comments from
people with MS, that cannabis based medicines can significantly improve
spasticity which is a common, complex symptom of MS. For this reason the MS
Trust has campaigned for the availability of a licensed medicine that can be
properly controlled and prescribed. We have also invested money and resources in
developing the body of knowledge by funding clinical research into the
effectiveness of cannabis based medicines. The launch of Sativex is therefore a
milestone for the NHS and the MS Trust, and we are delighted. It will now be
down to specialist professionals to assess people and we hope that this can
happen quickly'.
As with many medicines, Sativex does not work for everyone. The clinical trials
show that about half of all people who add it to their existing medication find
that it can provide relief from the debilitating symptoms of spasticity
associated with MS.5 It contains active ingredients called cannabinoids which
are extracted from cannabis plants grown in a strictly controlled environment.
Professor John Zajicek, Consultant in Neurology at Derriford Hospital, Plymouth
and a world leader in cannabinoid research commented, 'The launch of Sativex is
a milestone in the journey of cannabinoid medicines.' He continued, 'Existing
treatments used to help people experiencing spasms and cramps often produce side
effects that can be difficult to cope with. Sativex has mainly mild to
moderate side effects which are usually controlled by simply adjusting the dose.
It is a good addition to existing treatments which will be of great benefit in
the future.'
Talking about the launch of Sativex , Simon Gillespie, Chief Executive of The MS
Society said, 'The launch of any new medicine to help people with MS is good
news and we know from our members that Sativex has been long awaited. We hope
that it will be made freely available on the NHS to anyone who might benefit
from it.'
Sativex is only available on prescription from specialist doctors with
experience in treating MS spasticity. It is sprayed into the mouth either onto
the inside of the cheek or under the tongue. The person with MS decides how
many sprays they need in any one day which is typically 8 sprays per day (daily
limit of up to 12 sprays).1 Extensive clinical trials mean that there is now
about one thousand patient years exposure to Sativex in the UK.6
A series of photo images in connection with this story are available to download
at www.fovea.tv and/or call Peter Corbin on 020 70892627.
-ends-
Enquiries:
+----------------------------------------+----------------------+
| GW Pharmaceuticals plc | (Today) + 44 20 7831 |
| | 3113 |
+----------------------------------------+----------------------+
| Dr Geoffrey Guy, Chairman | + 44 1980 557000 |
+----------------------------------------+----------------------+
| Justin Gover, Managing Director | |
+----------------------------------------+----------------------+
| | |
+----------------------------------------+----------------------+
| GW PR | |
+----------------------------------------+----------------------+
| Financial Media: Ben Atwell / John | + 44 20 7831 3113 |
| Dineen | |
+----------------------------------------+----------------------+
| Other Media: Mark Rogerson | +44 7885 638810 |
+----------------------------------------+----------------------+
| | |
+----------------------------------------+----------------------+
| Bayer Schering Pharma | +44 7711 200384 |
+----------------------------------------+----------------------+
| Cherry Wood / Kim Lemon (Liberation | + 44 7771 561079 |
| Communications) | |
+----------------------------------------+----------------------+
| | |
+----------------------------------------+----------------------+
| GW Advisers: Piper Jaffray Ltd | +44 20 3142 8700 |
+----------------------------------------+----------------------+
| Neil Mackison / Rupert Winckler | |
+----------------------------------------+----------------------+
Note to Editors
About MS
Multiple sclerosis (MS) is a condition that affects approximately 100,000 people
in the UK in which damage occurs within the central nervous system (CNS - brain
and spinal cord).2 As the nerves of the CNS control the functions of the whole
body, symptoms can affect many different areas.7 MS is the most common
disabling disease of the CNS affecting young adults and is usually diagnosed
between the ages of 20 and 40 years.7,8 MS is twice as common in women than in
men.7,8
More information can be found on the following patient group websites:
· MS Society http://www.mssociety.org.uk/
· MS Trust http://www.mstrust.org.uk/
About spasticity
Spasticity is a common symptom associated with Multiple Sclerosis (MS)3 and is a
major contributor to disability.9 It is caused by damage to the nerves in the
central nervous system which carry messages instructing muscles how to move
resulting in an involuntary muscle overactivity.10
In a survey, 84% of people with MS reported symptoms of spasticity.11 Moderate,
severe or total spasticity is reported in 34% of individuals.11 Symptoms include
loss of mobility, painful spasms, stiffness and / or weakness of muscles.10 As a
consequence an individual may have difficulty in walking, picking up objects,
washing, dressing and other everyday activities involving movement.3 In
addition to causing a great deal of distress to the person with MS, mood,
self-image and motivation can also be affected.4
About Sativex
Sativex was developed by UK-based GW Pharmaceuticals plc in specific response
to the MS population's unmet need for a prescription cannabis based medicine.
Manufactured under Home Office licence at an undisclosed location in the UK,
Sativex will be marketed in the UK by Bayer Schering Pharma.
Sativex is indicated as add-on treatment for symptom improvement in patients
with moderate to severe spasticity due to multiple sclerosis (MS) who have not
responded adequately to other anti-spasticity medication and who demonstrate
clinically significant improvement in spasticity related symptoms during an
initial trial of therapy.1
Sativex contains active ingredients called 'cannabinoids', which are extracted
from cannabis plants grown and processed under strictly controlled conditions.
Cannabinoids react with cannabinoid receptors that occur naturally throughout
our bodies, including in our brains.12 A receptor is a site on a brain cell
where certain substances can stick or "bind" for a while. If this happens, it
has an effect on the cell and the nerve impulses it produces, which causes a
'dimming down' of the symptoms of spasticity. In patients who respond to
Sativex , it is this effect which helps to improve their symptoms of spasticity
and to help them cope better with their usual daily activities.13
Sativex is primarily made up of a 1:1 ratio of two particular cannabinoids -
cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).14 The CBD:THC
formulation is believed to provide a good balance of clinical effect - a
significant decrease in MS spasticity- to THC-related side effects.13,14
Main effects of CBD and THC:13
+----------------------------------+---------------------------------+
| CBD | THC |
+----------------------------------+---------------------------------+
| Anti-inflammatory, | Analgesic, anti-spasmodic, |
| anticonvulsant, antipsycotic, | anti-tremor, anti-inflammatory, |
| anti-oxidant, neuroprotective, | appetite stimulant, anti-emetic |
| immunomodulatory | |
+----------------------------------+---------------------------------+
The most common side effects of Sativex are dizziness, which occurs mainly in
the first few weeks of treatment, and fatigue. These reactions are usually mild
to moderate and improve within a few days even if treatment is continued.1
Of the 84% of people with MS who have reported symptoms of spasticity,
approximately 11,500 would be eligible for treatment with Sativex (those who are
already on combination therapy). Of these about 50% will have a good response
from Sativex .5 The NHS price for Sativex is GBP125 per 10ml vial which for a
typical patient means approximately GBP11 per day.15
Sativex is a registered trade mark of GW Pharmaceuticals and GW Pharmaceuticals
is the Marketing Authorisation holder for Sativex .
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Haematology & Neurology, Oncology and
Women's Healthcare. With innovative products, Bayer Schering Pharma aims for
leading positions in specialised markets worldwide. Using new ideas, Bayer
Schering Pharma aims to make a contribution to medical progress and strives to
improve the quality of patients' lives.
Further information can be found at www.bayerscheringpharma.co.uk
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
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions
and forecasts made by Bayer Group or subgroup management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer's public reports which are available on the
Bayer website at www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.
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 and other products by
consumer and medical professionals.
References
1. Sativex Summary of Product Characteristics, 2010
2. Multiple Sclerosis Society. About MS. Available at
http://www.mssociety.org.uk/about_ms/index.html (Last accessed: 14/04/2010)
3. Multiple Sclerosis Trust. Multiple Sclerosis Information for Health and
Social Care Professionals. 2007. Available at
http://www.mstrust.org.uk/downloads/ms_information_for_hps.pdf (Last accessed:
14/04/2010).
4. Multiple Sclerosis International Federation. Spasticity in MS. MS in
focus. Issue 12. 2008. Available at
http://www.msif.org/docs/MSinFocusIssue12EN.pdf (Last accessed: 14/04/2010).
5. Montalbán X, Wright S. Trial period for new symptomatic treatments:
Lessons learnt from a Sativex in MS spasticity clinical trial. Oral session 131
presented at the 25th Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS). September 2009
6. Data on file, GW Pharmaceuticals
7. Multiple Sclerosis Trust. MS Explained. 2008. Available at
http://www.mstrust.org.uk/information/publications/msexplained/ (Last accessed:
14/04/2010)
8. NHS Choices. Multiple Sclerosis Introduction. Available at
http://www.nhs.uk/conditions/multiple-sclerosis/pages/introduction.aspx (Last
accessed: 22/04/2010)
9. Beard S, et al. Health Technol Assess 2003;7(40)
10. Multiple Sclerosis Trust. Spasticity and Spasms factsheet. November 2009
11. Rizzo MA, et al. Prevalence and treatment of spasticity reported by
multiple sclerosis patients. Multiple Sclerosis 2004;10:589/595
12. GW Pharmaceuticals. Cannabinoid Science: Mechanism of action. Available at
http://www.gwpharm.com/mechanism-of-action.aspx (Last accessed: 07/05/10)
13. GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available
at http://www.gwpharm.com/types-compounds.aspx (Last accessed: 07/05/10)
14. GW Pharmaceuticals. Frequently Asked Questions. Available at
http://www.gwpharm.com/sativex-faqs.aspx(Last accessed: 07/05/10)
15. Sativex Prescribing Information, 2010
This information is provided by RNS
The company news service from the London Stock Exchange
END
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