Refused on appeal, GW needs new confirming Phase III data.

LONDON -- GW Pharmaceuticals plc lost the battle to register its cannabis-based medicine, Sativex, for the treatment of spasticity in multiple sclerosis on the basis of the existing data file, but won the war by convincing regulators there are no objective endpoints in the indication.

The upshot is that the company needs only to confirm the results of the trial in a second Phase III study. GW started such a trial in December when it launched the appeal against the refusal to grant Sativex a UK license, and that will report early in 2006.

News that the Committee of Safety on Medicines would turn down the appeal leaked last week, prompting an 18 percent fall in the …