Research Update

RNS Number:9665Z
GW Pharmaceuticals PLC
17 March 2006



                             GW PHARMACEUTICALS PLC
                            ("GW" or "the Company")


  PRELIMINARY RESULTS FROM SATIVEX(R) PHASE III MULTIPLE SCLEROSIS SPASTICITY
                                     STUDY


GW to evaluate optimal regulatory filing strategy with marketing partners


Porton Down, UK, 17 March 2006 - GW Pharmaceuticals plc (AIM: GWP) today
announces preliminary results from a Phase III study of Sativex(R) in the relief
of spasticity in people with Multiple Sclerosis (MS). This study is one of a
number of Phase III studies which are currently taking place to support approval
of Sativex across Europe in a range of target indications.


Analysis of the per protocol population (those patients that complied with the
study protocol) showed a positive and statistically significant improvement in
the primary outcome measure (p0.05).


Dr Stephen Wright, R&D Director at GW, said:


"The study supports the significant positive data already generated from
previous GW studies in people with MS who have failed to respond to currently
available anti-spasticity treatments. This is a high need patient population and
we are considering the regulatory impact of this new study in light of the
different outcomes of the two statistical analyses and in the context of our
overall regulatory strategy for Sativex. Whilst this study may provide GW with a
regulatory route in Europe for the spasticity indication, the bulk of our
positive clinical data relates to neuropathic pain. We have two further Phase
III neuropathic pain studies due to report later this year and we need to
consider with our marketing partners the relative benefits of awaiting that data
before submitting the next regulatory filing."


The trial reported today was a randomized placebo-controlled parallel group
study in 335 people with spasticity due to MS. All patients entering the study
were taking best available anti-spasticity medication and remained on such
medication through the trial. Hence, any improvements seen in the trial were
obtained over and above currently available treatment. The primary outcome
measure was the improvement in spasticity as measured on a 0-10 numeric rating
scale. The duration of treatment in the study was 14 weeks.


In this trial, the primary endpoint, and two key secondary endpoints (the
Responder Analysis and the Carer Global Impression of Change), in the per
protocol analysis achieved statistical significance, whereas the outcomes in the
ITT analysis were positive but non-significant. The lack of significance in the
ITT analysis was not due to a lack of effect of Sativex, but rather was due to a
larger than expected placebo response, thus reducing the size of the difference
between the two groups. Had the placebo response been the same as in GW's
previous completed Phase III spasticity study, the ITT analysis in this new
study would also have been statistically significant.


Separately, a pooled analysis across the three Sativex MS spasticity studies now
completed, incorporating a total of 652 patients, shows Sativex to be
significantly superior to placebo (p