UK: GW's cannabis-based spray a step closer

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Lydia Adetunji

Financial Times

Thursday 20 Jan 2005

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GW Pharmaceuticals yesterday reported more positive clinical trial data on
its cannabis-based medicine Sativex and said it expected a UK regulatory
hearing on the drug this summer.

GW has already reported positive clinical trial data showing that Sativex,
an under-the-tongue spray, helps to control the symptoms of multiple
sclerosis and neuropathic pain.

Yesterday, the company produced fresh data on Sativex showing positive
results with patients suffering from severe cancer pain. The trials were
Phase III, the last stage before a drug is approved for marketing, and
showed that about 40 per cent of patients on Sativex saw a 30 per cent
improvement in their pain levels.

The company said the new data demonstrated the broad potential of the
treatment, which has already received preliminary approval in Canada but is
still caught up in the UK regulatory approval process.

British approval - which would enable Sativex to be marketed across Europe
- was originally expected in late 2003 but has taken longer than
anticipated after the Medicines and Healthcare Products Regulation Agency
asked for further data on its safety and effectiveness. That delay has
affected GW's share price, which has fallen from a high of 254p in
mid-2003. Shares in GW yesterday rose 2.5 per cent to 120.5p.

Geoffrey Guy, GW's executive chairman, said all the quality and safety
issues related to Sativex had been dealt with, with one efficacy- related
matter to be resolved at the Medicines Commission. He said the outcome of
that hearing should be known in the summer. If it is successful, the
treatment will be granted a product licence in the UK immediately. "It's
simply a matter of time before we get the approval," Dr Guy said.

The company, which has a marketing deal for Sativex with Bayer of Germany,
is also preparing to apply for approval for an eventual launch of the
treatment in the US.

GW yesterday also reported its results for the year to September 30 2004,
which showed pre-tax losses of UKP15.7m and cash reserves of UKP17.8m. It
said it expected 2005 to be a turning point as it started to generate
commercial revenues from product sales.

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