Britain’s GW Pharmaceuticals Plc said on Wednesday it expected regulators to approve its pioneering cannabis-based medicine for multiple sclerosis during the second quarter. The firm, which grows some 40,000 marijuana plants a year at a secret location in the English countryside, is awaiting a ruling from Britain’s Medicines Control Agency on Sativex, which it has partnered with Germany’s Bayer AG. It said the assessment process was ‘well advanced’ and completion was expected during the second quarter of 2004. GW had originally hoped for approval last year but said the process had been slowed up by a flood of drug submissions to the regulator.”

Reuters adds, “Sativex, which is sprayed into the mouth rather than smoked, is a make-or-break product for the small company, which made a net loss of 8.1 million pounds ($14.85 million) in the year to September 30, compared with an 11.2 million pounds loss the year before. … 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. But industry analysts said the key to drug’s commercial success would depend on its label, setting out its use in different patient groups.” Executive Chairman Geoffrey Guy said  “the initial label might be limited but this would be expanded over time.” He added, “If the regulators offer me approval on a label which perhaps may be a subset of what we’ve requested, I’m not going to turn that down. As soon as we have approval we will then go back to vary the label. We have four or five other trials that will come through during the year to expand the label.”