GW Pharmaceutical releases H1 FY07 results

GW Pharmaceuticals, the UK-based developer and manufacturer of cannabinoid medicines, including Sativex, has released its interim results for H1 FY07.

Net loss for the period was GBP 6.7m, compared with GBP 6.9m in the same period of 2006, which was in line with expectations. Cash and short term deposits at 31 March 2007 were GBP 21.9m. Net cash inflow for the period was GBP 2.0m

GW and partner Bayer HealthCare Pharmaceuticals also announced that Health Canada, the Canadian regulatory agency, had issued a Qualifying Notice for the approval of Sativex in the relief of cancer pain.

Sativex is already approved and marketed in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in Multiple Sclerosis (MS) in adults.

Other highlights of H1 FY07:

• Sativex US licence agreement signed with Otsuka, including USD 18m signature fee, additional milestone payments up to USD 255m as well as a significant long term commercial supply price and royalty
• Discussions at an advanced stage with Otsuka to enter into global cannabinoid research collaboration in the field of CNS and cancer treatment
• Positive discussions with FDA on US development programme, which is the first large-scale US clinical trial in cancer pain due to start during summer 2007
• European regulatory application process ongoing for Sativex in the relief of MS Spasticity
• THCV, a potential treatment for obesity and metabolic disorders, enters phase I clinical trials

Dr Geoffrey Guy, GW's Chairman, said: "We look forward to the start of our first large scale US clinical trial, to be fully funded by Otsuka, and the approval and launch of the cancer pain indication in Canada. In addition, the European regulatory submission for Sativex in MS spasticity is expected to conclude. We also expect to sign a global cannabinoid research collaboration with Otsuka and to see progress of early stage programmes under this arrangement, as well as progress with the early clinical development of THCV as a potential treatment for obesity and related metabolic disorders."