Submission to Health Canada

RNS Number:5110Y
GW Pharmaceuticals PLC
11 May 2004


Embargoed until 0700                                                 11 May 2004

                              GW Pharmaceuticals plc

         GW submits New Drug Submission for Sativex(R), Cannabis-Based
                           Medicine, to Health Canada

GW Pharmaceuticals plc ("GW" or "the Company") and Bayer HealthCare,
Pharmaceuticals Division - Canada ("Bayer") announce that GW has submitted a New
Drug Submission for Sativex(R), a cannabis-based medicinal extract product, to
Health Canada.

Sativex has been developed by GW and, subject to approval, will be exclusively
marketed in Canada by the Pharmaceuticals Division of Bayer HealthCare.

Sativex has been developed to provide a cannabis-derived pharmaceutical product
for the treatment of the debilitating symptoms of Multiple Sclerosis ("MS") and
severe neuropathic pain. The product is a whole plant medicinal cannabis extract
containing Tetranabinex(TM) (tetrahydrocannabinol or THC) and Nabidiolex(TM)
(cannabidiol or CBD) as its principal components. The medicine is administered
by means of a spray into the mouth.

Approximately 50,000 people in Canada are diagnosed with Multiple Sclerosis.
Pain is a common symptom in MS and significant pain occurs in 42-65% of all MS
patients.1 A survey of Canadian patients with neuropathic pain cited a 72.8%
finding of inadequate pain control.2

Dr Geoffrey Guy, Executive Chairman of GW, said, "In recent years, GW has
conducted an active and positive dialogue with Canadian officials regarding the
introduction of Sativex. Subject to regulatory approval, we now look forward to
bringing a non-smoked, cannabis-based prescription medicine to market in
Canada."

Philip Blake, President of Bayer Inc., said, "We are very pleased to be working
in partnership with GW to bring this innovative medicine to the Canadian market
once it has been approved. MS patients often suffer from pain associated with
this disease. We hope that Sativex offers another treatment option."

GW submitted a product licence application for Sativex to the UK Medicines and
Healthcare products Regulatory Agency in March 2003.

References:

1 Boivie, J. Central Pain, Textbook of Pain, 1999; 879-914
2 Gilron I, et al., Patients' attitudes and prior treatments in neuropathic
  pain: a pilot study. Pain Research and Management 7 (4): 1999-203, 2002.

                                    - Ends -

Enquiries:

GW Pharmaceuticals plc                                            01980 557000
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR                                       07885 638810

Weber Shandwick Square Mile                                       020 7067 0700
Kevin Smith


Notes to Editors

A New Drug Submission is the application for the marketing authorization of a
new prescription medicine to enable sale and distribution in Canada.

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a
pharmaceutical research and development programme to develop non-smoked
cannabis-based prescription medicines. Full details of GW and the company's
clinical trials programme can be found at www.gwpharm.com

GW's clinical research programme is being carried out by a team of
pharmaceutical professionals experienced in drug development and, in particular,
the development of plant-based medicines and drug delivery systems. GW's team is
also supported by a number of prominent scientific advisers in this field in
Europe and North America.

Bayer HealthCare, a subgroup of Bayer AG with sales of approximately 8.9 billion
Euro in 2003, is one of the world's leading, innovative companies in the health
care and medical products industry.

The company combines the global activities of the divisions Animal Health,
Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600
people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve
human and animal health worldwide. Our products enhance well-being and quality
of life by diagnosing, preventing and treating disease.

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



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

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