Pubdate: Wed, 08 Jun 2005
Source: Reuters (Wire)
Copyright: 2005 Reuters Limited
Contact: London, UK
Website: http://www.reuters.com
Details: http://www.mapinc.org/media/364

GW PHARMA LOSES UK APPEAL ON CANNABIS DRUG-REPORT

LONDON (Reuters) - GW Pharmaceuticals Plc (GWP.L: Quote, Profile,
Research) has lost an appeal to be allowed to market its cannabis
therapy Sativex without having to do additional clinical trials,
according to a report published on Monday.

Online medical news agency Agence de Presse Medical (APM)
(www.apmnews.com), citing an unidentified government source, said
Britain's Medicines Commission had heard an appeal by the firm two
weeks ago and rejected its case.

Although Sativex is approved in Canada for the relief of neuropathic
pain in multiple sclerosis, UK officials said in December they wanted
more evidence about its efficacy when used to relieve spasticity. This
triggered the appeal by GW Pharma to the commission.

A spokesman for the Medicines Commission told Reuters he could not
comment on the case.

APM said the Medicines and Healthcare Products Regulatory Agency --
the British agency responsible for approving drugs -- was now
understood to be waiting for health ministers to confirm the rejection.

Losing the appeal would represent a blow not only to GW Pharma but
also to its German partner Bayer AG (BAYG.DE: Quote, Profile,
Research), which has exclusive marketing rights. The companies had
hoped UK approval would open the way to mutual recognition in the rest
of the European Union.

Sativex was initially expected to be approved in Britain by the end of
2003 but has suffered numerous delays. The under-the-tongue spray is
GW Pharma's most advanced product.

GW Pharma spokesman Mark Rogerson said the company was still waiting
to hear the outcome of the appeal. "When we have heard the result of
that appeal we will make a statement," he said.
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MAP posted-by: Derek