Porton Down, UK, 1 April 2009: GW Pharmaceuticals plc (GWP:AIM) today announces that it has received confirmation from its licensing partner, Laboratorios Almirall S.A., that it will pay to GW a milestone payment of £8 million. GW will receive the payment within the next few weeks.
Under the GW-Almirall contract, this milestone payment became due in the event that GW obtained positive results in its recent Sativex® Multiple Sclerosis Spasticity Phase III trial and, in addition, Almirall considered that the data was sufficiently positive to include a country within their licensed territory (Europe excluding UK) as part of the resultant Sativex regulatory submission. Following their review of the complete data from the positive Phase III trial announced on 11th March, Almirall have now confirmed their positive opinion of the data and that they wish to include Spain in the forthcoming regulatory submission.
GW expects to submit the regulatory submission in Q2 09 to the UK and Spain under the European decentralized procedure. Following approval in the UK and Spain, GW and Almirall intend to expand into other European countries under the mutual recognition procedure.
Justin Gover, GW’s Managing Director, said, “We are delighted that Almirall share our positive view of the Phase III data and confidence in the prospects for regulatory approval. This milestone payment further underlines GW’s robust financial position.”
About GW
GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.
