Research Update

RNS Number:5779Y
GW Pharmaceuticals PLC
19 June 2007



 Sativex(R) receives Qualifying Notice for approval in Canada for the relief of
                                  Cancer Pain



Porton Down, UK; Toronto, Canada; 19 June 2007: GW Pharmaceuticals plc (AIM:
GWP) and Bayer HealthCare Pharmaceuticals announce that Health Canada, the
Canadian regulatory agency, has issued a Qualifying Notice for the approval of
Sativex(R) in the relief of cancer pain. Sativex is already approved and
marketed in Canada as adjunctive treatment for the symptomatic relief of
neuropathic pain in Multiple Sclerosis ("MS") in adults. This approval was
granted under the NOC/c policy.



GW filed the application in October 2006 with Health Canada under the Notice of
Compliance with conditions (NOC/c) policy. The approved indication will be "
adjunctive analgesic treatment in adult patients with advanced cancer who
experience moderate to severe pain during the highest tolerated dose of strong
opioid therapy for persistent background pain". Health Canada has completed its
regulatory review in line with its 200 day review target.



Sativex has been developed by UK-based GW Pharmaceuticals and is exclusively
marketed in Canada by Bayer.



Under the NOC/c process, the issue of a Qualifying Notice confirms that Sativex
qualifies to be considered for approval in cancer pain and sets out the
conditions and post-approval undertakings upon which the marketing authorization
for Sativex in this indication can be granted. The conditions for the approval
of Sativex in cancer pain are in accordance with standard guidance provided by
the regulator for NOC/c approvals and include a commitment to ongoing clinical
research. This process is identical to that under which Sativex is already
approved in the MS neuropathic pain indication.



GW is required to respond and accept the conditions within 30 days. Following
this, Health Canada will review this response, subject to a 30 day review
target. Should the response be acceptable, Health Canada can then be expected to
proceed to finalise the marketing authorisation.



Dr Geoffrey Guy, GW's Chairman, said, "We are delighted to receive this
Qualifying Notice from Health Canada and look forward to receiving regulatory
approval for Sativex in the relief of cancer pain in the next few months. This
additional regulatory approval represents a further step in our broad-based
regulatory strategy for Sativex, which is designed to secure approvals for this
important new medicine across a range of separate therapeutic indications in
countries across the world over the coming years."



Philip Blake, President and CEO of Bayer Inc., said, "Pain is one of the most
debilitating and feared symptoms of advanced cancer. The approval of Sativex for
the treatment of these high need patients is further recognition of the value of
this important medicine and we shall now actively commence our launch plans for
this indication."



Sativex in Cancer Pain



GW has completed a positive Phase III study in Europe in 177 patients with
cancer pain. The trial was a multi-center double-blind, randomized,
placebo-controlled parallel group study. Patients in the study had advanced
cancer and were experiencing pain that was not responding adequately to strong
opioid medication (e.g. morphine). In addition to study medication, all patients
remained on their existing opioid and other analgesic medication during the
trial. In this study, Sativex achieved a statistically significant improvement
in comparison with placebo in pain as measured on a numerical rating scale (p=
0.014), a primary endpoint of the study. A responder analysis showed that 43 per
cent of patients on Sativex showed a greater than 30 per cent improvement in
their pain (p=0.024).



Cancer-related pain can be defined as pain caused by cancer, by cancer treatment
such as surgery, radiation therapy or chemotherapy, or by the side effects of
treatment. Severe pain is experienced by at least two thirds of patients with
advanced disease.  It is estimated that between 14 per cent and 47 per cent of
these patients will achieve inadequate pain relief from opioid based approaches
and will continue to suffer pain (1).



Dr Paul Daeninck, Director, Symptom Management Group for Cancer Care Manitoba
and Assistant Professor, Depts of Internal Medicine and Family Medicine,
University of Manitoba, said, "Pain remains a significant unmet medical need for
many patients with cancer, who may be unable to gain adequate pain relief from
even the best use of existing strong opioid medicines. Furthermore, a proportion
of patients are simply unable to tolerate opioids in doses that may be required
to relieve their pain. In short, there is a clear need for effective new
analgesics.  The results with Sativex show that it can provide additional pain
relief to this group of patients and may represent an important new option in
the treatment of cancer pain."



In 2006, the United States Food and Drug Administration (FDA) accepted an
Investigational New Drug (IND) Application for Sativex to enter into Phase III
clinical trials in the U.S. for the treatment of cancer pain. The first U.S
trial is due to commence in the next few months.





Enquiries:
GW Pharmaceuticals plc                                Today: [phone]
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director

Financial Dynamics                                    Tel: [phone]
David Yates / Ben Atwell

Bayer Inc.
Alison Bing                                           Tel: [phone]





Notes to editors:



Sativex



Sativex is a buccal spray composed primarily of tetrahydrocannabinol (THC) and
cannabidiol (CBD), a non-psychoactive cannabinoid. The product is standardized
by both composition and dose. Sativex is thought to act via cannabinoid
receptors that are distributed throughout the central nervous system and in
immune cells (2).  These receptors are distributed throughout the pain pathways
of the nervous system, and their activation is known to reduce pain in relevant
pain models.



In 2005, Health Canada approved Sativex for the symptomatic relief of
neuropathic pain in adults with Multiple Sclerosis. This approval was granted
under the NOC/c policy.



Notice of Compliance with Conditions (NOC/c) policy



The NOC/c policy applies to drug submissions intended for the treatment,
prevention or diagnosis of a serious, life-threatening or severely debilitating
illness or condition for which there is no existing therapy available on the
Canadian market which possesses a similar therapeutic profile or for which the
new submission demonstrates a significant improvement in the benefit/risk
profile over alternate available products.



Products approved under Health Canada's NOC/c policy, have demonstrated
promising benefit, are of high quality and possess an acceptable safety profile
based on a benefit/risk assessment for the approved use. The promising nature of
the clinical evidence is to be confirmed with further studies.



About GW Pharmaceuticals



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 Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading,
innovative companies in the healthcare and medical products industry.  The
company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care, and Pharmaceuticals divisions.  Bayer HealthCare Pharmaceuticals
comprises the following business units: Women's Healthcare, Diagnostic Imaging,
Specialized Therapeutics, Hematology/Cardiology and Oncology.  The company's aim
is to discover and manufacture products that will improve human health worldwide
by diagnosing, preventing and treating diseases.



This news release may contain forward-looking statements that reflect GW's
current expectations regarding future events, including the clinical development
and regulatory clearance of its 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 GW's research strategies, the applicability of the discoveries made
therein, the successful and timely completion of clinical studies, including
with respect to Sativex and GW's other products, the uncertainties related to
the regulatory process, and the acceptance of Sativex and other products by
consumers and medical professionals.





Footnotes:



(1)  Zech DF, Grond S, Lynch J et al.  Validation of WHO guidelines for cancer
pain relief - a 10 year prospective study.  Pain 1995; 63: 65-76.).

(2)  Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Last
accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/
prodpharma/notices-avis/conditions/sativex_factsheet_e.html.






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