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Politics : THE WHITE HOUSE -- Ignore unavailable to you. Want to Upgrade?

To: Gersh Avery who wrote (19280)	4/14/2008 4:02:00 PM
From: d[-_-]b	Read Replies (1) \| Respond to of 25737

Maybe someday - GW Pharma's cannabis drug fails Hemscott, 08/04/08 09:28 hemscott.com In a final-stage trial, the group's Sativex drug unexpectedly failed to show a statistically significant reduction in neuropathic pain relief. GW Pharmaceuticals said the medicine's Phase III pain relief trial among multiple sclerosis patients had narrowly failed to reach statistical significance because of an unexpectedly large placebo effect. Some 50% of subjects given the Sativex mouth spray had a 30% improvement in pain scores, as rated by a standardised 0-10 system. But for the trial to succeed, GW was required to demonstrate not only that Sativex was effective but that it was markedly more effective than a placebo. Unfortunately for the company, around 45% of the placebo group also enjoyed a 30% or more improvement in pain. "The previous trial yielded a highly significant reduction in pain and it is extremely disappointing that this couldn't be replicated," said Paul Cuddon, an analyst at KBC Peel Hunt. "The company attribute this to a large response in the placebo group. While valid, this indicates that the effect of Sativex is marginal, and we retain our doubts as to whether the product will ever prove a commercial success in any of the indications. "We set a 50p price target, which is at the lower end of our DCF valuation range, and recognise that there is likely to be a financing gap by year end 2009," Cuddon told clients. GW had £18.5m of net cash as of March 31. It reported a loss after tax of £10.58m for 2007, and is forecast to lose about the same amount this year as well as a further £7m in 2009. Shares tumbled 17.5%, down 12.5p to 59p, having fallen 8% late yesterday. The stock had added 15% in the six months before today, sharply outperforming its sector. Sativex is unique among medicines currently available because it is derived from the cannabis plant, rather than a synthetic cannabinoid compound. It was approved in Canada for prescription use in April 2005 as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis, and is available in the UK as an unlicensed medicine. GW argued that the Phase III MS trial was flawed as it allowed patients to self-medicate up to the desired optimum level of pain relief, as they would be able to do in a real world setting. As a result, patients with the placebo took significantly more doses, which GW says skewed the findings. If the data are compared on equal doses the statistical significance improves. The company's next tests - a Phase III trial for MS spasticity, expected by the end of the year, and a US cancer pain trial set to conclude in 2010 - will both be conducted using fixed doses rather than self medication. Edison Investment Research, - an analytical gun-for-hire used by small companies which believe they are misunderstood - commented: "Despite today's understandably negative market reaction, GW's investment case centres on the approval of Sativex in Europe and the US. This is still possible in 2009/10, wih approval, with study data in spasticity and cancer pain remaining a key trigger for the shares." That Panglossian take on the news was echoed by Investec, GW's house broker, even though it downgraded to "hold" from "buy". "Today’s phase III result showed yet again that GW’s lead product works. It did not, however, reach a statistically watertight conclusion. We believe this was down to the challenges of designing trials in conditions such as pain and MS which are innately variable and subjective," Investec told clients. "In our view, this is a very meaningful improvement in symptoms, given that the patients enrolled in the trial are those that have already failed to gain adequate pain relief from the best of existing pain-alleviating products, and hence are intrinsically ‘tough to treat patients’. Despite this, the trial showed that Sativex delivered such a level of pain relief for around 55% of patients. In our view, this is an excellent result, and as far as we are aware unprecedented in this desperate patient group who suffer intractable pain." GW anounced last February it had signed an exclusive agreement for Otsuka Pharmaceutical to develop and market Sativex in the United States. It has a similar agreement with Almirall to market Sativex in Continental Europe, while Bayer Healthcare has been appointed exclusive exclusive distributor in the UK and Canada.