Good news for GW Pharmaceuticals: it is looking likely that its multiple sclerosis spray Sativex will be approved in the UK and Spain during the second quarter, after the drug passed a critical point in the regulatory pathway to market.

Shares in the Porton Down, UK-based group were given a boost after it emerged that the regulatory process for Sativex (delta-9-tetrahydrocannabinol and cannabidiol) has reached ‘Day 150’ of the decentralised procedure with no major quality, safety or efficacy issues left to resolve, which basically means that the drug is approvable.

According to the group, the only points left to clarify relate to the wording in the patient information leaflet for the drug, and so it expects Sativex to be given the go-ahead as a treatment for symptoms of spasticity due to MS sometime in April-June.

Unsurprisingly, shareholders have welcomed the news, particularly as the imminent approvals will trigger a major cash injection into GW’s business. Following a green light in the UK, the group stands to receive a £10 million milestone payment from Bayer Schering Pharma, which will market Sativex in the country, and the final nod in Spain will see a further £2.5 million from Almirall, which holds marketing rights in the rest of Europe.

Strong cash position
According to analysts at Edison Investment Research, the milestone payments will put GW in a strong position financially, with around £22 million in net cash at the firm’s disposal to help it expand R&D activities and sow further seeds for future growth.

Commenting on the news, Stephen Wright, GW’s R&D Director, said it is “a major milestone” in both the regulatory process for Sativex and the company’s future prospects. “This progress with Sativex also provides further validation of GW’s cannabinoid platform and the significant long term promise of GW’s portfolio of cannabinoid medicines,” he added.

Submissions for approval in additional European countries will be made under the mutual recognition procedure later in the year, the firm said.