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| High Hopes for GW's Medicinal Cannabis |
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Posted by FoM on July 08, 2001 at 20:30:10 PT By Anthea Lawson Source: The Times UK 
Last time Geoffrey Guy tried to bring a pharmaceutical company to market, he couldn’t create enough investor interest. Ethical Holdings, which specialised in drug delivery, failed to float in June 1997. This time, it couldn’t have been more different. To a fanfare of press interest, his latest venture, GW Pharmaceuticals, has just raised £25 million, well over the projected £16 million, and valued Dr Guy’s interest in the company at £47 million. Not bad for a man whose business is selling marijuana. In just four years, he has moved from failure to a six-times oversubscribed success, in an area where no other company is yet attempting to tread, although of course that may now change. By curious coincidence GW, the only company with a licence to grow cannabis for medical purposes, announced its successful flotation on the same day that Meconic, which deals in heroin and cocaine for medical purposes, was bought by Johnson Matthey. Meanwhile, cannabis is moving off the street and into Parliament, with Peter Lilley, the senior Tory backbencher, calling for decriminalisation. His surprise intervention follows the decision by Lambeth police to cease prosecuting cannabis users. The money raised by GW will be used to expand phase three clinical trials for its pain-relief drug for multiple sclerosis and cancer patients, to accelerate development research for a rheumatoid arthritis drug, and to expand cultivation and production facilities ready for the drug approval it hopes will be forthcoming by 2003. That cultivation, measured by the tonne, takes place in “greenhouses’’ at “secret locations’’ in the South of England, facilities that Dr Guy describes as “a cross between a spaceship and an operating theatre”. Staff are vetted and drug tested, and every bit of cannabis transported between facilities must be accompanied by a written movement order. For a long time, Guy says, “the people that would have liked to develop cannabis-based medicines were generally not the people running drug companies”. Now they have come together, in the form of this dapper, pinstriped, articulate salesman. He is careful choosing his words, admitting that it is vital to keep careful control of this story, or he will lose the benefits of the rapid achievements made so far. He rarely refers to cannabis by name, preferring to speak coyly of “the material’’. Given that he is teetotal, decaffeinated and non-smoking, it seems rude to ask if he inhaled at college. He did not. His managing director, Justin Gover, admits to have “come into contact with the material before, but not for many, many years”. They are both at pains to emphasise that the Home Office has not “legalised cannabis” for GW, as is often stated. It is the final cannabis-derived drugs, if passed by the regulator, that will be legal, not cannabis itself — just as morphine is derived from opium. At the moment they have a licence from the Home Office, dating from June 1998, to “cultivate, possess and supply’’ an otherwise illegal substance for medical purposes. Patients have been queuing up to get on their trials; they have had to hire a full-time nurse to “counsel patients that recruitment into clinical trials can’t be done overnight”. Of the 3,000 MS patients that responded to a questionnaire, a third said they already used cannabis; the others were put off by the legal and smoking aspects. So how did GW rather than anyone else manage to persuade the Government to offer its support? “We were uniquely qualified to do it,” says Guy, referring to his training as a doctor at Barts and his background in drug delivery with Ethical Holdings and plant-based medicine with its offspring company, Phytopharm. He had long been interested in the therapeutic possibilities of cannabis, but it was at a 1997 conference on the subject organised by the Pharmaceutical Society and the MS Society that he realised that wider sentiment was starting to change. “Patients were turning up in court, admitting to possession of these materials, and were being let off or given very light sentences, and there was sympathy for their predicament,” recalls Guy. But the pharmaceutical industry is a conservative beast. “At that meeting someone said: ‘Look, isn’t there a drug company here? How can we move ahead?’ I could see a few faces I recognised, sinking quietly into their seats, they probably didn’t even want people to know they were there. I thought here goes, stood up, and talked for 20 minutes.” Guy was part of a delegation that approached the Home Office later that year, and was told that although it had no plans to reschedule cannabis (it is currently in schedule 1, along with other drugs of no medical value such as LSD and ecstasy) it would “welcome research”. Others apparently took this as a no, but he saw it as a challenge and pressed on. After presenting a complex proposal describing his planned route from plant to medicine, the licence was granted. Under usual plant-medicine rules it would take several years to establish a crop of sufficient size, purity and strength to allow research to begin. GW skipped this stage by bringing in a Dutch company called Hortapharm, run by Americans with a similar interest in medicinal cannabis. They had already started a growing programme to encourage stronger quantities of certain cannabinoids, and so “from day one we already had all the starting materials as a basis for pharmaceutical products”. This, says Gover, helps to explain the apparently extraordinarily short time from outset of research to predicted market-time. Some analysts are not so sure. Warnings have been voiced that Guy’s big-talking history at Ethical and Phytopharm should not inspire confidence, while the outspoken Erling Refsum of Nomura says that Guy is “underestimating the regulatory difficulties” and has “far too optimistic a view” on how rapidly the first drug can be brought to market. “You can buy a better drug cheaper on the corner of the street,” he disparages, pointing to the lack of sparkling sales of Marinol, the only other cannabis-related drug on the market. Guy is careful to explain why US-made Marinol, a chemically synthesised version of THC, one of cannabis’s active ingredients, has not been a success. THC is what gives the high when cannabis is used recreationally, and is what medical research initially focused on. But GW’s research has shown that as important is CBD, or cannabidiol, which has antiinflammatory properties of its own and takes away some of the side-effects, the high in other words, of the THC. Marinol, which is THC only, is taken orally, and as the average punter at Glastonbury could vouchsafe, THC has a rather stronger and more unpredictable psychoactive effect when eaten than when inhaled, to the degree that patients in the US, trying to use it to treat appetite suppression, have found it very difficult to use. GW, Guy underlines, is developing sprays and inhalers rather than pills, and is focusing on using THC and CBD together, in their more natural plant-extracted form, where they can cancel out each other’s side-effects. Guy does plan to take GW’s drugs to the US, and says that the Government there, despite being rather more “robust” in its drugs enforcement than the UK, has indicated it will “welcome a solution based on science”. He hopes to start clinical trials there early next year. A letter of recommendation from the Home Office may have helped Guy’s case, as will the fact that he will import only the finished drug into the US, leaving all that naughty weed cultivation in the UK. Source: Times, The (UK) Related Articles & Web Site: UK Medicinal Cannabis Project Soft Drug Turns To Hard Sell Cannabis-Grower GW to Float with £175m Tag Home Comment Email Register Recent Comments Help |
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