Nov 05, 2002
By Ben Hirschler, European Pharmaceuticals Correspondent
Multiple sclerosis patients in Britain could get cannabis medicine on prescription as early as next year.
GW Pharmaceuticals Plc, the company behind the treatment, said on Tuesday that four Phase III trials showed its product was significantly better than placebo in relieving disease symptoms.
The medicine, which is sprayed into the mouth rather than smoked, effectively reduced nerve damage pain, spasticity and sleep disturbance in the tests involving around 350 patients.
Those expecting a marijuana high from the new drug, however, are likely to be disappointed since the British company's product is designed to have minimal psychoactive effects.
GW--which cultivates some 40,000 cannabis plants a year at a secret location in the English countryside--now plans to seek marketing approval from Britain's Medicines Control Agency early next year.
"The performance of GW's medicine has exceeded our own expectations," said Executive Chairman Geoffrey Guy. "Subject to regulatory approval, we are now on track to deliver our first prescription medicine to the UK market next year."
GW had previously forecast a product launch in early 2004 but the good results mean patients could get the drug earlier.
Britain's Multiple Sclerosis Society, representing patients with the nerve disease, said the news was "very encouraging".
"We hope we are moving much closer to the day when people with MS will have access to cannabis-derived drugs which have been proved both effective and safe in the treatment of symptoms of this long-term condition," said spokesman David Harrison.
Many multiple sclerosis sufferers have long been convinced that cannabis helps their condition and an estimated 10% of British patients are estimated to already use it illegally.
GW is conducting a further five Phase III trials as part of an overall programme which is the largest ever undertaken into the medicinal effects of cannabis. The spray is also being studied for treating pain in cancer and spinal cord injury.
Julie Simmonds, biotechnology analyst at Evolution Beeson Gregory, expects GW to generate peak sales of around 250 million pounds ($388.9 million) a year in Europe and Canada, the first markets where approval will be sought.
The British government has already indicated it is ready to alter rules governing the use of cannabis to allow doctors to prescribe GW's medicinal formulation.
Europe and Canada are expected to follow any green light from Britain within 6 to 9 months, but approval in the United States will be at least 2 years behind due to the stringent tests required by the Food and Drug Administration.
No decision on pricing has yet been made but Guy told Reuters GW's product would be competitive with rival medicines for nerve pain that cost some 1,200 to 2,000 pounds a year.
GW, which reported a loss of 5.3 million pounds in the 6 months to March 31, expects to sign a marketing deal with a large pharmaceutical company by early next year.
Shares in GW, which had jumped 17.5% on Monday after the company announced it would publish the Phase III data on November 5, eased 3% on profit-taking to 146 pence by 1040 GMT, valuing the group at just under 150 million pounds. The company floated at 182p in 2001.
© 2002 Reuters Ltd