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GW clears cannabis hurdle
Richard Irivng The Times
Wednesday 20 Apr 2005 DRUG regulators in Canada ushered in a new era in pain management yesterday when they approved a cannabis-based medicine for use in patients suffering from multiple sclerosis. The move, the first time that cannabis has been approved for use in a prescription drug, marks a significant breakthrough for GW Pharmaceuticals, the British company that has spent millions of pounds developing Sativex, an under-the-tongue spray made from cannabis plants, over the past six years. Shares in the AIM-listed company jumped 11 1/2p to 132 1/2p on hopes that British regulators, who are deliberating on the merits of the treatment, will take their lead from their Canadian counterparts and give the medicine the green light. An earlier attempt at drug approval in the UK was knocked back after the Medicines and Healthcare Products Regulatory Agency (MHRA) raised concerns over the way crucial test results were presented. However, the drug maker is appealing against the decision with the Medicines Committee, a senior advisory panel to the agency. The committee is expected to rule in the early summer on whether further trials are necessary. GW believes that Sativex can help to relieve several symptoms relating to MS, including neuropathic pain - pain in the nerve endings - muscle spasms and even sleep deprivation. The company has tested the spray on more than 1,500 volunteers and is about to start talks with US regulators over the steps it might need to take to secure approval in America. About 80,000 people suffer from MS in the UK. More than half of patients complain of severe pain, which can either occur spontaneously or be provoked by touch, movement or temperature fluctuations. Canadian authorities, which already allow MS sufferers to take unrefined cannabis to help to ease their suffering, had intimated that Sativex would be approved late last year and the company expects to launch the medicine in Canada within the next few weeks. Geoffrey Guy, GW's executive chairman, said that he was optimistic that other regulators would follow the lead of those in Canada. "By the end of the decade we should be in all of the major markets around the world, with the possible exception of Japan," he said. Dr Guy declined to forecast sales for the drug, which GW is marketing jointly with Bayer, the German pharmaceuticals giant. GW grows thousands of marijuana plants at a secret location in the English countryside, after special dispensation by the Government to grow the drug for medical research. GW's dispute with the MHRA centres on whether the results of a recent trial are statistically relevant. If the Medicines Committee rules against GW, the company will have to conduct new trials. Dr Guy said that he was confident he could provide enough data to satisfy the committee's concerns, clearing the way for a launch in the UK this summer.
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