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. - --- MAP posted-by: Derek