Analysts and investors have reacted positively to the news that the UK’s GW Pharmaceuticals has filed its cannabis-based drug Sativex in Europe for multiple sclerosis spasticity.

The Porton Down-based drugmaker noted that the regulatory submission has been filed in Spain and the UK and the latter’s regulatory authority, the Medicines and Healthcare products Regulatory Agency, is acting as reference member state for Europe. GW expects to find out if Sativex (delta-9-tetrahydrocannabinol and cannabidiol) can be marketed by the end of 2009 or early 2010.

If approved, Sativex will be marketed in the UK by Bayer and in the rest of the European Union by Spain’s Almirall. Stephen Wright, GW’s R&D director, said the firm was pleased to have completed and filed the submission “within a very short period of time of receiving the latest positive Phase III data”. That data, which involved 573 patients, was unveiled in March and showed that the mean change in spasticity severity in those who received the GW drug compared with placebo, was "highly statistically significantly in favour of Sativex”.

Analysts were impressed and Jacob Plieth at Edison Investment Research said that the submissions “represents another positive development in the investment case for GW”. He noted that the UK and Spain approvals would trigger a combined £12.5 million from Bayer and Almirall.

GW also announced its financials for the six months ended March which show that net profit reached £4.0 million, compared with a loss of £4.0 million in the like, year-earlier period. Turnover was up to £16.1 million from £5.7 million.

A Sativex Phase IIb/III cancer pain trial, which is being funded by Japan’s Otsuka as part of the US development programme, is ongoing and due to report in spring 2010. Geoffrey Guy, GW’s chairman, said the firm “is now making the transition from a late-stage development company to an emerging pharmaceutical business with excellent growth prospects” and has “now entered its most exciting time since its foundation.”

Sativex’ road to approval has been a rocky one but another analyst, KBC’s Paul Cuddon, noted that “since the pivotal trial was designed largely by the regulators, we feel there is relatively low risk of a rejection". He added that “a maiden set of interim profits, strong cash position and the fact that they've filed Sativex for approval in Spain and the UK can all be considered goods news".