Re Sativex

RNS Number:8627J
GW Pharmaceuticals PLC
13 December 2007



  GW Welcomes Move by UK Regulator to Provide More Information for Sativex(R)
                                  Prescribers


Porton Down, UK; 13 December 2007: GW Pharmaceuticals plc (AIM: GWP) welcomes
the publication today by the UK regulator, the Medicines & Healthcare products
Regulatory Agency (MHRA) of a Public Information Report on Sativex(R), GW's
cannabinoid spray medicine.


The MHRA has taken this unprecedented step due to its view of the "huge public
interest" in Sativex and the fact that approximately 1400 patients in the UK
have so far received the medicine on prescription on a named patient basis. New
patients continue to be prescribed Sativex every day. Hence, the MHRA considers
that it is in the public interest for potential prescribers to have further
information on the medicine.


Dr Geoffrey Guy, Chairman, said, "We welcome the MHRA's appreciation of the
public interest in Sativex and recognition of the extent of prescription use of
Sativex in the UK. We continue to receive enquiries from UK physicians and
patients on a daily basis and this report will serve to provide them with more
information about the medicine and its use."


Dr Guy added, "As we have previously announced, there is an outstanding efficacy
issue to be resolved prior to full regulatory approval for Sativex in the relief
of Multiple Sclerosis spasticity. This issue, detailed in the report, is being
addressed through an additional Phase III clinical trial, which commenced
recently."



Enquiries:

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



Notes to Editors



Further Information on the Public Information Report

Report Conclusions

The Report confirms previous statements by GW that the major issue to be
overcome prior to approval of Sativex for the relief of spasticity in people
with Multiple Sclerosis relates to the provision of specific additional efficacy
data. Key summary conclusions of the Report are:

  * All pharmaceutical points raised during the procedure have been resolved
    satisfactorily.

  * There are no preclinical objections to the granting of a marketing
    authorisation.

  * The safety profile is considered acceptable in principle for the proposed
    patient population and indication, providing sufficient efficacy is
    demonstrated.

  * The remaining efficacy issue is to carry out a prospectively planned study
    to confirm GW's "post hoc analyses supporting an argument that non
    responders can be identified in a 4 week therapeutic trial, and that the
    mean treatment effect in the remaining patients who would continue to
    receive treatment, would be clinically significant."


In addition to the guidance disclosed in the assessment report on the additional
required clinical trial, GW has separately received formal "Scientific Advice"
from MHRA on the company's protocol design and statistical analysis plan.


Safety Information

The safety information detailed in the report is consistent with that already
contained in the Canadian Product Monograph, which is approved by Health Canada
for Sativex in the relief of neuropathic pain in MS and cancer pain, as well as
the information which has previously been provided to UK physicians who
currently prescribe Sativex on a named patient basis.



Expert Statement

The Report includes a consensus statement by a panel of independent clinical
experts specialising in the treatment and rehabilitation of people with MS and
in clinical trial design, who were asked to review and comment on the Sativex
data and the MHRA's assessment thereof. This panel was chaired by Lord Walton of
Detchant, an eminent British neurologist and past president of the Royal Society
of Medicine and the General Medical Council of Great Britain. The statement
concludes:


"We conclude that Sativex meets a currently unmet medical need in patients where
there is no other conservative treatment option.  It is our view that Sativex
should be licensed and become available on prescription for patients with
spasticity due to multiple sclerosis, and we urge the MHRA to do so."



Full Report

The full report can be found on the MHRA website: www.mhra.gov.uk



About Sativex

Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC
(delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose
oro-mucosal spray; each 100uL spray contains 2.7mg THC and 2.5mg CBD. The
Sativex 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.



Sativex is already approved and marketed in Canada as adjunctive treatment for
the symptomatic relief of neuropathic pain in MS, and for the relief of cancer
pain.  Health Canada has approved Sativex under its Notice of Compliance with
conditions (NOC/c) policy.



In the US, the lead indication for Sativex is cancer pain. On 26 November, GW
and its US licensing partner, Otsuka, announced that the first US Phase II/III
cancer pain trial had been initiated.



GW has to date entered into three Sativex license agreements - with Otsuka in
the US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe
(ex-UK).


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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