GW Pharma gets £8M as its cannabis drug is submitted for European approval

Milestone payment

GW Pharmaceuticals plc has received confirmation from its licensing partner, Laboratorios Almirall SA, that it will make a £8 million milestone payment, after deciding to submit the cannabis-based medicine for approval in Spain.

Under GW Pharma’s licensing deal with Almirall the milestone payment follows positive results in the recently completed Phase III trial of Sativex in treating spasticity in multiple sclerosis, and Almirall’s decision that the data was good enough to submit for review.

Almirall has now confirmed it wants Spain to be included in the forthcoming regulatory submission, which GW will file in the UK and Spain under the European decentralised 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 shares 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.”