Research Update

RNS Number:3695I
GW Pharmaceuticals PLC
26 November 2007





       Sativex(R) Commences US Phase II/III Clinical Trial in Cancer Pain



London, UK; Tokyo, Japan; 26 November 2007: GW Pharmaceuticals plc (AIM: GWP)
and Otsuka Pharmaceutical Co., Ltd. today announced that the first US Phase II/
III dose-ranging trial has been initiated to evaluate the efficacy and safety of
Sativex(R) in the treatment of pain in patients with advanced cancer, who
experience inadequate analgesia during optimized chronic opioid therapy.


The principal investigator of this study is Dr. Russell K. Portenoy, Chairman of
the Department of Pain Medicine and Palliative Care at Beth Israel Medical
Center in New York City. This five-week, placebo-controlled study will include
approximately 40 centers primarily in the US and recruit a total of 336
patients.  Patients enrolled in this study must have advanced cancer for which
there is no known curative therapy and have a clinical diagnosis of
cancer-related pain, which is not wholly alleviated with their current opioid
treatment.  The primary objective of the study is to evaluate the potential role
and dose range of Sativex in these patients as an adjunct to their pre-existing
pain medications.  The primary endpoint of the study will be the response rate
for patients at the end of 5 weeks of therapy, as defined by a 30% or greater
reduction in the 11-point, Numeric Rating Scale (NRS).


Commenting on the importance of this study, Dr. Portenoy, said, "Studies suggest
that more than one-third of patients with cancer, and more than three-quarters
of those with advanced disease, have chronic pain.  Large surveys indicate that
optimal opioid therapy does not yield sufficient relief in a substantial
proportion of these patients.  There is a clear need for new treatments to
improve these outcomes and it is our hope that cannabinoid formulations may
represent an important option in the future.  This US-based study is a welcome
step in assessing the role of Sativex(R) as a potential new treatment for cancer
pain."


Dr Geoffrey Guy, GW's Chairman, said, "GW has spent many years preparing for the
US development of Sativex(R) and has established open and positive interactions
with relevant federal agencies.  The start of the first large scale US clinical
trial is a major milestone for the company and for the future prospects for
Sativex(R). We are delighted to be working in close collaboration with our
partner, Otsuka, in advancing Sativex(R) toward the goal of obtaining US
regulatory approval.


Dr. Taro Iwamoto, President of Otsuka Pharmaceutical Development and
Commercialization, Inc., likewise noted that "Otsuka is very excited to be
working with GW Pharmaceuticals for the development of this potential
alternative approach to the treatment of advanced cancer pain.  The initiation
of this US clinical trial for Sativex is consistent with our mission to develop
products for better health."


Sativex(R) is an investigational new product composed primarily of two
cannabinoids: CBD (cannabidiol,) and THC (delta 9 tetrahydrocannabinol). Sativex
(R) will be administered as a metered dose oro-mucosal spray each 100(micro)L
spray contains 2.7mg THC and 2.5mg CBD. The Sativex(R) formulation is
standardized by both composition and dose and is supplied in small spray vials.
The components of Sativex have been shown to bind to cannabinoid receptors that
are distributed throughout the central nervous system and in immune cells.


This Phase II/III dose ranging study will attempt to replicate and extend data
from a previous, two-week clinical trial in 177 patients conducted in Europe. In
this European study, Sativex(R) was administered to patients with terminal
cancer and persistent pain that was not fully relieved by current strong opioid
therapy.  The primary endpoint of this study was the change from baseline to
endpoint in the NRS pain score.  Sativex, as adjunctive treatment to strong
opioid therapy, was associated with a larger decrease in NRS score than was
placebo and strong opiods (p=0.014).  In addition, 43% of patients who received
Sativex(R), while remaining on opioids, exhibited at least a 30% decrease in
their pain score compared to 21% of patients receiving placebo and opioids (p=
0.024)


Treatment related adverse events in this study were reported by 85% of patients
receiving Sativex and by 75% of patients receiving placebo.  The most common
adverse events (> 10%) reported by patients in this study were somnolence (15%
Sativex(R) vs. 13% placebo); nausea (12% Sativex(R) vs. 11% placebo) and
dizziness (12% Sativex(R)  vs. 5% placebo).  Serious adverse events reported by
more than one patient receiving Sativex were urinary retention (n=2) and
progression of the underlying cancer (n=6).


Enquiries:
For GW:
                       GW Pharmaceuticals plc            Today: [phone]
                       Dr Geoffrey Guy, Chairman    Thereafter: + 44 1980 557000
                       Justin Gover, Managing
                       Director
                       Mark Rogerson, Press and PR         Tel: + 44 7885 638810

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

For Otsuka:            US Inquiry
                       Debbie Kaufmann                      Tel: [phone]
                       Japan Inquiry
                       Hideki Shirai                            [e-mail]



Notes to Editors


About GW-Otsuka


On 14 February 2007, GW and Otsuka entered into a major long term strategic
alliance. The relationship commenced with the signing of an exclusive license
agreement to develop and market Sativex(R) GW's lead product, in the US. Under
this agreement, GW and Otsuka jointly oversee US clinical development and
regulatory activities as well as the commercialization strategy. GW is
responsible for carrying out the US clinical development program, the costs of
which are borne by Otsuka.  Otsuka will be responsible for the marketing and
sales activities in the US.


On 9 July 2007, GW and Otsuka signed a global research collaboration for the
study of cannabinoids in the field of Central Nervous System (CNS) and oncology
to research, develop and commercialize a range of candidate cannabinoid
products.


About Otsuka Pharmaceutical Co., Ltd

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company
with the corporate philosophy: 'Otsuka - people creating new products for better
health worldwide.' Otsuka researches, develops, manufactures and markets
innovative and original products, with a focus on pharmaceutical products for
the treatment of diseases and consumer products for the maintenance of everyday
health. Otsuka is committed to being a corporation that creates global value,
adhering to the high ethical standards required of a company involved in human
health and life, maintaining a dynamic corporate culture, and working in harmony
with local communities and the natural environment.


The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately
31,000 people in 17 countries and regions worldwide. Otsuka and its consolidated
subsidiaries earned US$7.2 billion in annual revenues in fiscal 2006.


Focusing on the central nervous system, the circulatory, respiratory, and
digestive systems, ophthalmology and dermatology, Otsuka's pharmaceutical
product business engages in the research and development, manufacture and sale
of pharmaceuticals, aiming to maximize the assets of a global network to address
unmet medical meets.

For additional information, visit www.otsuka-global.com



About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock
Exchange, in June 2001. Operating under license from the UK Home Office, the
company researches and develops cannabinoid pharmaceutical products that
alleviate pain and other neurological symptoms in patients who suffer from
serious ailments. 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 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


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(R)  and other products by
consumer and medical professionals.






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