Fri 30 April, 2004
GW Pharmaceuticals says its hopes to win regulatory approval for a pioneering cannabis-based medicine for multiple sclerosis have been hit by a fresh delay.
The firm, which grows some 40,000 marijuana plants a year at a secret location in the English countryside, said on Friday it now did not expect UK regulators to approve the medicine, called Sativex, until after the end of June.
GW GWP.L had originally hoped Sativex, which is partnered with Germany's Bayer, would be approved last year, but said in January the process would be delayed until the second quarter because of a flood of drug submissions in the UK.
"Whilst the directors of GW have not altered their expectations that approval of Sativex will be granted, it is now clear that the regulatory process will continue past the end of the second quarter," the firm said in a statement.
GW said a large number of the regulator's original questions had been resolved and that it was now working to submit further information and clarification. It did not say when it expected the process to close.
Sativex, which is sprayed into the mouth rather than smoked, is a make-or-break product for GW, which made a net loss of 8.1 million pounds in the year to September 30.
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 say the key to the drug's commercial success would depend on its label, setting out its use in different patient groups.
GW shares, which were floated at 182 pence each in 2001, closed at 178-1/2
pence on Thursday, valuing the business at about 201 million pounds.
Copyright © 2004, Reuters