[DrJay2001]

Sativex Spray effective in treating cancer pain

I just received the note below from Dr. Ethan Russo. Phase III clinical study results have been released by GW Pharmaceuticals in regard to the treatment of cancer related related pain.

As you can see below three different sublingual sprays were used. The first (and only effective one) spray was Sativex a combination of THC and CBD (I believe 1:1 ratio). The second was THC alone (ineffective) and placebo (ineffective).

Not only does this clinical double blind study demonstrate the efficacy of Sativex for cancer pain but puts the lie to Marinol which is identical to the THC only spray used and found ineffective.

Finally, the study demonstrates the synergistic effect of cannabinoids with opiates producing the opiate sparring effect.

Yours,
Dr Jay
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GW Announces Positive Preliminary Results with its Cannabis-based Medicine (SativexR) in Phase III Cancer Pain Trial

19/01/2005

GW Pharmaceuticals announces positive preliminary results in a Phase III clinical trial with SativexR in 177 patients with severe cancer pain.

The trial was a multi centre double-blind, randomised, 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.

The study included two different study medications - Sativex (a cannabis medicine containing tetrahydrocannabinol (THC) and cannabidiol (CBD)) and a THC-rich extract. Patients entering this three arm study were randomised equally to one of Sativex, THC extract or placebo. Each of these study medications were administered by means of a spray into the mouth.

In this Phase III trial, Sativex achieved a statistically significant
improvement in comparison to placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in their pain (p=0.024).

Analysis of escape medication, a second primary endpoint, showed that there were no significant changes in the use of escape medication. The improvements seen in pain were therefore attributable to the positive effects of Sativex.

The other active arm of this study, GW's THC extract did not show a significant effect in pain (p=0.24). This trial therefore suggests that Sativex is the more effective product for use in cancer pain.

In the trial, the adverse event data showed the medicines to be generally well tolerated.

Approximately 40 per cent of cancer sufferers at present have unmet needs in pain suppression.

Dr Stephen Wright, GW's R&D Director, said, "Patients in this trial were suffering intense pain as a result of their cancer despite using currently available strong opioid treatments and therefore have a very high clinical need. The data from this important trial further demonstrates the broad potential of Sativex, not only in its initial Multiple Sclerosis and neuropathic pain markets, but also in cancer and potentially other types of chronic pain. These positive results suggest that Sativex may represent avaluable new treatment option for this group of patients.

"We will now be actively reviewing the next steps, including a possible further Phase III confirmatory clinical trial, towards securing regulatory approvals for the use of Sativex in cancer pain."

Sativex is currently the subject of regulatory applications in both the UK and Canada. A Qualifying Notice for approval in Canada was received in December 2004 for the use of Sativex in the treatment of neuropathic pain in Multiple Sclerosis. In both countries, upon approval, Sativex will be exclusively marketed by Bayer HealthCare.

- Ends -

Enquiries:

GW Pharmaceuticals plc

Today: 020 7067 0700

Dr Geoffrey Guy, Chairman

Thereafter: 01980 557000

Justin Gover, Managing Director
Dr Stephen Wright, R&D Director
Mark Rogerson, Press and PR

07885 638810
Weber Shandwick SquareMile
020 7067 0700
Kevin Smith / Sarah MacLeod



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 eventscould differ materially from those projected herein and depend on a numberof factors, including (inter alia), the success of the Company's researchstrategies, the applicability of the discoveries made therein, thesuccessful 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 byconsumers and medical professionals.