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GW Pharmaceuticals Announces Uk Launch Of World’s First Prescription Cannabis-Medicine


6/21/2010 11:41:20 AM

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. 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. 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 £10m 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.

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 Dineen + 44 20 7831 3113 Other Media: Mark Rogerson +44 7885 638810

Bayer Schering Pharma +44 7711 200384 Cherry Wood / Kim Lemon (Liberation Communications) + 44 7771 561079

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 t 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 £10m 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


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