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 Sativex Regulatory Update

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PostSubject: Sativex Regulatory Update   Mon Apr 12, 2010 11:21 am

Sativex Regulatory Update

Sativex Update - UK and Spanish regulators confirm no major issues - Approvals expected Q2 2010.
18 March 2010

Porton Down, UK, 18 March 2010: GW Pharmaceuticals plc (GWP:AIM) today provides an update on the progress of its regulatory submission for Sativex® Oromucosal Spray for the treatment of the symptoms of spasticity due to Multiple Sclerosis. The regulatory submission was filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK acting as the Reference Member State.

The regulatory process has now reached “Day 150” of the decentralised procedure and both the UK and Spanish regulators have concluded that there are no major quality, safety or efficacy issues remaining to be resolved. Resolution is now required only of points of clarification related to finalisation of wording on the patient information leaflet. We expect this document to be reviewed by the regulators in the coming weeks.

Once the regulators have agreed final wording on the patient leaflet, the decentralised procedure can close and the process will enter its final phase. This final phase, known as the national phase, takes place separately in the UK and Spain and its purpose is to finalise local wording on product packaging and related documents.

GW therefore expects regulatory approval in the UK and Spain during Q2 2010.

Dr Stephen Wright, GW’s R&D Director, said, “This is a major milestone in the regulatory process for Sativex, and for GW’s future prospects. We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. 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.”

Sativex will be marketed in the UK by Bayer Schering Pharma, and in the rest of the European Union by Almirall S.A. Upon UK regulatory approval, GW expects to receive a £10m milestone payment from Bayer. A further £2.5m milestone payment is payable by Almirall following both regulatory and pricing approval in Spain.

Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.

Source ="http://www.gwpharm.com/Sativex%20%20Regulatory%20%20Update.aspx"
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