Over 1m canadiens on medical cannabis
A recent study conducted by PricewaterhouseCoopers for Health Canada indicated that more than 1,000,000 Canadians currently rely upon medical cannabis for relief from pain, nausea and loss of appetite. Cannabis clubs formed across Canada in response to the incredible demand for a safe and reliable source of medical cannabis. These clubs obtain cannabis to members who provide a verifiable letter of diagnosis for a chronic or terminal illnesses from a physician. The senate recognizes cannabis clubs as a primary source of awareness of education.

Cannabis As Living Medicine (C.A.L.M.) is a national, peer-run organization that provides more than 1,700 Canadians living with severe or chronic illnesses with safe and continuous access to medicinal cannabis in a safe empowering environment. C.A.L.M. is Eastern Canadas first medical cannabis club, established in 1996, and serves members in the Greater Toronto Area and across Canada. Currently, C.A.L.M. is a superior dispenser of medical cannabis that functions like a wellness centre. C.A.L.M. is open seven days a week in order to provide clients with consistent and reliable access to medical cannabis.

Cannabis is once again becoming a medically recognized form of medicine around the world. Canadians overwhelmingly support the legalization of medical cannabis (90%). C.A.L.M. welcomes all inquiries regarding cannabis as medicine.

Currently, the biggest hurdle to the medical use of cannabis is its politicization and legality. These hurdles burden Canadas most vulnerable people with concerns of safety and expense, and expose them to the threat of criminal prosecution. At the same time these medical users have little to no regulation of the medicine they use. It is a long term goal of C.A.L.M. to help overcome the stigma and other obstacles that prevent the full benefits of cannabis from being realized.

GW Pharmaceuticals PLC
15 January 2007





Results of Sativex(R) Phase III Neuropathic Pain Trials Demonstrate Benefits for
High Need Treatment-Resistant Patients



15 January 2007: GW Pharmaceuticals plc ('GW') today announces preliminary
results of two Phase III studies of Sativex(R), its cannabinoid spray medicine,
in peripheral neuropathic pain. These studies are part of a programme to
generate data for the future expansion of the use of Sativex in Europe beyond
Multiple Sclerosis (MS) into other pain conditions.



The results of the study in patients with neuropathic pain characterised by
allodynia show that patients taking Sativex obtain clinically important
improvements in their management of pain and quality of sleep. In comparison
with placebo, statistically significant improvements were seen for key outcome
measures, including a positive result in the primary analysis of patient
response, the outcome measure recommended by regulatory authorities.



The results of the study in patients with painful diabetic neuropathy show that
patients taking Sativex obtained substantial improvements in their pain, indeed
among the highest level of response seen in the published literature. There was
an abnormally large placebo response in this study, which means that the data
are more difficult to interpret categorically.



Dr Stephen Wright, GW's R&D Director, said, 'Neuropathic pain is one of the most
difficult types of chronic pain to treat. These studies focused on particularly
high need patients, who were already taking the best available pain treatments,
and yet still suffered severe pain. Even in this most difficult to treat
population, Sativex has produced improvements over and above current treatments
that are highly meaningful to the everyday lives of patients.'



These two studies form part of a programme of neuropathic pain trials conducted
to date by GW and reinforce the large body of positive data already generated.
These data contribute significantly to a future regulatory filing in the use of
Sativex as a treatment for neuropathic pain. GW intends to continue to add to
this evidence base.



Allodynia Study



This multi-centre double-blind, randomised, placebo-controlled parallel group
study in 246 patients examined the effect of Sativex in patients with
neuropathic pain characterised by allodynia. Allodynia is the occurrence of pain
in response to a normally non-painful stimulus (e.g. clothes touching against
the skin). It is often intense and can occur in patients suffering from a range
of conditions that damage the peripheral nerves (e.g. nerve lesions,
post-herpetic neuralgia). Patients in this study were being treated with a range
of currently available analgesics, which were maintained during the course of
the study.



The results of this study confirm the efficacy of Sativex. The responder
analysis of the primary endpoint (the proportion of patients obtaining a
clinically meaningful improvement in pain relief), was statistically
significantly in favour of Sativex (p=0.03) for the full Intention to Treat
(ITT) population. In addition, two of the key pain-related secondary efficacy
endpoints, the Patient's Global Impression of Change (p<0.03) and the assessment
of sleep quality (p<0.01), were also statistically significantly in favour of
Sativex. All the other secondary efficacy endpoints were in favour of Sativex.



European and US regulators recommend a responder analysis of the primary
endpoint in pain studies as the key assessment of outcome. This analysis was
positive and confirms that Sativex produces a clinically important benefit over
and above currently available treatments in a meaningful proportion of otherwise
treatment-resistant patients. An additional analysis of the mean endpoint data
was strongly in favour of Sativex and approached statistical significance.



Diabetic Neuropathy Study



This multi-centre double-blind, randomised, placebo-controlled parallel group
study in 297 patients examined the effect of Sativex in patients with painful
diabetic neuropathy. Patients in this study were being treated with a range of
currently available analgesics, which were maintained during the course of the
study.



In this study, patients taking Sativex showed a 30% mean improvement in pain
scores, among the highest level of response seen in the published literature.
One third of Sativex patients achieved over a 50% improvement in pain. However,
the study results are difficult to interpret due to an abnormally large response
in the placebo group. As such, although all outcome measures compared to placebo
are in favour of Sativex, they do not reach statistical significance.



With regard to safety, the pattern of adverse events in both studies was similar
to that seen in other Sativex studies.



Peripheral neuropathic pain forms part of a regulatory strategy to obtain
approvals for Sativex across major markets in a range of indications, including
MS symptoms, central neuropathic pain and cancer pain. Sativex is the subject of
an ongoing regulatory application in four selected European countries for the
symptomatic relief of spasticity in MS. Upon initial approval, it is intended to
extend the MS spasticity indication into other European countries through the
mutual recognition procedure. Since the rules do not permit a parallel
regulatory application in neuropathic pain, GW's regulatory strategy for this
indication is to continue to build the clinical evidence base whilst the MS
spasticity regulatory process is ongoing. Hence, additional confirmatory trials
have been under preparation for some months and ethics committee approvals
obtained. With the benefit of today's results, the designs of the additional
studies can be finalised prior to their commencement. These studies will further
contribute to a future regulatory submission in neuropathic pain.



Sativex is approved and marketed in Canada for the symptomatic relief of central
neuropathic pain in MS, and is the subject of an ongoing regulatory submission
in Canada for the relief of cancer pain.



Enquiries:
GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Dr Geoffrey Guy, Executive Chairman
Justin Gover, Managing Director
Dr Stephen Wright, R&D Director

Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates, Ben Atwell





About GW Pharmaceuticals plc

GW was founded in 1998 and listed on the AiM, a market of the London Stock
Exchange, in June 2001. Operating under licence from the UK Home Office, the
Company is developing cannabis-derived pharmaceutical products for patients with
multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury,
rheumatoid arthritis, and other severe medical conditions.



GW has assembled a team of over 100 scientists with extensive experience in
developing both plant-based prescription pharmaceutical products and medicines
containing controlled substances. GW is dedicated to developing treatment
options that alleviate pain and other neurological symptoms in patients who
suffer from serious ailments.



For further information, please visit the Company's website:
www.gwpharm.com




About Neuropathic Pain

Neuropathic pain is caused by damage to or dysfunction of the nervous system. It
is usually chronic and accompanied by unpleasant burning or shooting sensations,
or extreme sensitivity to touch.



It is estimated that at least 1 per cent. of the world's population suffers from
neuropathic pain, including over 600,000 patients in UK.



Neuropathic pain can be difficult to diagnose and may be confused with
nociceptive pain (caused by bodily injury - 'visceral' or 'somatic'). The
presence of allodynia can confirm that the pain experienced by the patient is
truly neuropathic.



Neuropathic pain can be associated with many conditions including multiple
sclerosis, stroke, cancer, spinal cord injury, physical trauma and peripheral
neuropathy resulting from diabetes. It can also occur in patients who have
previously suffered from shingles, a condition known as post-herpetic neuralgia.



Neuropathic pain is one of the most difficult types of chronic pain to treat.
Since treatment options are limited, doctors often prescribe a combination of
therapies in an attempt to relieve symptoms.






This information is provided by RNS
The company news service from the London Stock Exchange












GW Pharmaceuticals PLC
15 January 2007





Results of Sativex(R) Phase III Neuropathic Pain Trials Demonstrate Benefits for
High Need Treatment-Resistant Patients



15 January 2007: GW Pharmaceuticals plc ('GW') today announces preliminary
results of two Phase III studies of Sativex(R), its cannabinoid spray medicine,
in peripheral neuropathic pain. These studies are part of a programme to
generate data for the future expansion of the use of Sativex in Europe beyond
Multiple Sclerosis (MS) into other pain conditions.



The results of the study in patients with neuropathic pain characterised by
allodynia show that patients taking Sativex obtain clinically important
improvements in their management of pain and quality of sleep. In comparison
with placebo, statistically significant improvements were seen for key outcome
measures, including a positive result in the primary analysis of patient
response, the outcome measure recommended by regulatory authorities.



The results of the study in patients with painful diabetic neuropathy show that
patients taking Sativex obtained substantial improvements in their pain, indeed
among the highest level of response seen in the published literature. There was
an abnormally large placebo response in this study, which means that the data
are more difficult to interpret categorically.



Dr Stephen Wright, GW's R&D Director, said, 'Neuropathic pain is one of the most
difficult types of chronic pain to treat. These studies focused on particularly
high need patients, who were already taking the best available pain treatments,
and yet still suffered severe pain. Even in this most difficult to treat
population, Sativex has produced improvements over and above current treatments
that are highly meaningful to the everyday lives of patients.'



These two studies form part of a programme of neuropathic pain trials conducted
to date by GW and reinforce the large body of positive data already generated.
These data contribute significantly to a future regulatory filing in the use of
Sativex as a treatment for neuropathic pain. GW intends to continue to add to
this evidence base.



Allodynia Study



This multi-centre double-blind, randomised, placebo-controlled parallel group
study in 246 patients examined the effect of Sativex in patients with
neuropathic pain characterised by allodynia. Allodynia is the occurrence of pain
in response to a normally non-painful stimulus (e.g. clothes touching against
the skin). It is often intense and can occur in patients suffering from a range
of conditions that damage the peripheral nerves (e.g. nerve lesions,
post-herpetic neuralgia). Patients in this study were being treated with a range
of currently available analgesics, which were maintained during the course of
the study.



The results of this study confirm the efficacy of Sativex. The responder
analysis of the primary endpoint (the proportion of patients obtaining a
clinically meaningful improvement in pain relief), was statistically
significantly in favour of Sativex (p=0.03) for the full Intention to Treat
(ITT) population. In addition, two of the key pain-related secondary efficacy
endpoints, the Patient's Global Impression of Change (p<0.03) and the assessment
of sleep quality (p<0.01), were also statistically significantly in favour of
Sativex. All the other secondary efficacy endpoints were in favour of Sativex.



European and US regulators recommend a responder analysis of the primary
endpoint in pain studies as the key assessment of outcome. This analysis was
positive and confirms that Sativex produces a clinically important benefit over
and above currently available treatments in a meaningful proportion of otherwise
treatment-resistant patients. An additional analysis of the mean endpoint data
was strongly in favour of Sativex and approached statistical significance.



Diabetic Neuropathy Study



This multi-centre double-blind, randomised, placebo-controlled parallel group
study in 297 patients examined the effect of Sativex in patients with painful
diabetic neuropathy. Patients in this study were being treated with a range of
currently available analgesics, which were maintained during the course of the
study.



In this study, patients taking Sativex showed a 30% mean improvement in pain
scores, among the highest level of response seen in the published literature.
One third of Sativex patients achieved over a 50% improvement in pain. However,
the study results are difficult to interpret due to an abnormally large response
in the placebo group. As such, although all outcome measures compared to placebo
are in favour of Sativex, they do not reach statistical significance.



With regard to safety, the pattern of adverse events in both studies was similar
to that seen in other Sativex studies.



Peripheral neuropathic pain forms part of a regulatory strategy to obtain
approvals for Sativex across major markets in a range of indications, including
MS symptoms, central neuropathic pain and cancer pain. Sativex is the subject of
an ongoing regulatory application in four selected European countries for the
symptomatic relief of spasticity in MS. Upon initial approval, it is intended to
extend the MS spasticity indication into other European countries through the
mutual recognition procedure. Since the rules do not permit a parallel
regulatory application in neuropathic pain, GW's regulatory strategy for this
indication is to continue to build the clinical evidence base whilst the MS
spasticity regulatory process is ongoing. Hence, additional confirmatory trials
have been under preparation for some months and ethics committee approvals
obtained. With the benefit of today's results, the designs of the additional
studies can be finalised prior to their commencement. These studies will further
contribute to a future regulatory submission in neuropathic pain.



Sativex is approved and marketed in Canada for the symptomatic relief of central
neuropathic pain in MS, and is the subject of an ongoing regulatory submission
in Canada for the relief of cancer pain.



Enquiries:
GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Dr Geoffrey Guy, Executive Chairman
Justin Gover, Managing Director
Dr Stephen Wright, R&D Director

Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates, Ben Atwell





About GW Pharmaceuticals plc

GW was founded in 1998 and listed on the AiM, a market of the London Stock
Exchange, in June 2001. Operating under licence from the UK Home Office, the
Company is developing cannabis-derived pharmaceutical products for patients with
multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury,
rheumatoid arthritis, and other severe medical conditions.



GW has assembled a team of over 100 scientists with extensive experience in
developing both plant-based prescription pharmaceutical products and medicines
containing controlled substances. GW is dedicated to developing treatment
options that alleviate pain and other neurological symptoms in patients who
suffer from serious ailments.



For further information, please visit the Company's website:
www.gwpharm.com




About Neuropathic Pain

Neuropathic pain is caused by damage to or dysfunction of the nervous system. It
is usually chronic and accompanied by unpleasant burning or shooting sensations,
or extreme sensitivity to touch.



It is estimated that at least 1 per cent. of the world's population suffers from
neuropathic pain, including over 600,000 patients in UK.



Neuropathic pain can be difficult to diagnose and may be confused with
nociceptive pain (caused by bodily injury - 'visceral' or 'somatic'). The
presence of allodynia can confirm that the pain experienced by the patient is
truly neuropathic.



Neuropathic pain can be associated with many conditions including multiple
sclerosis, stroke, cancer, spinal cord injury, physical trauma and peripheral
neuropathy resulting from diabetes. It can also occur in patients who have
previously suffered from shingles, a condition known as post-herpetic neuralgia.



Neuropathic pain is one of the most difficult types of chronic pain to treat.
Since treatment options are limited, doctors often prescribe a combination of
therapies in an attempt to relieve symptoms.






This information is provided by RNS
The company news service from the London Stock Exchange















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2006 MoneyAM

morning all

GW Pharmaceuticals PLC
22 March 2007





GW and Otsuka Receive Hart-Scott-Rodino Clearance for Sativex(R) US License
Agreement

22 March 2007: GW Pharmaceuticals plc and Otsuka Pharmaceutical Co. Ltd today
announce that they have each received early termination by the United States
Federal Trade Commission and the Antitrust Division of the United States
Department of Justice of the required waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 with respect to the development and license
agreement announced on 14 February 2007 granting Otsuka exclusive rights to
develop and market Sativex(R), GW's lead product, in the United States. With
the grant of HSR clearance, GW and Otsuka have now received the approval of the
U.S. antitrust authorities necessary to close the transaction.

On 14 February 2007, GW and Otsuka announced that they had entered into a major
long term strategic cannabinoid alliance. The relationship has commenced with
the grant to Otsuka of an exclusive license to develop and market Sativex in the
U.S. The companies are also in detailed discussions with a view to entering
into a cannabinoid research collaboration in the field of Central Nervous System
(CNS) disorders and cancer treatment in order to research, develop and
commercialize a range of other early stage cannabinoid product opportunities.