UK Launch of First Prescription Cannabis-Medicine

 

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             |      [phone] | 
+----------------------------------------+----------------------+ 
|                                        |                      | 
+----------------------------------------+----------------------+ 
| Bayer Schering Pharma                  |     [phone] | 
+----------------------------------------+----------------------+ 
| Cherry Wood / Kim Lemon (Liberation    |    + 44  7771 561079 | 
| Communications)                        |                      | 
+----------------------------------------+----------------------+ 
|                                        |                      | 
+----------------------------------------+----------------------+ 
| GW Advisers: Piper Jaffray Ltd         | [phone]     | 
+----------------------------------------+----------------------+ 
| 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 
 
 MSCDMGMVVRVGGZM