What next for Sativex cannabis spray?

Following today's RNS and WebCast relating to GW Pharma's cannabis spray, Sativex, the following steps are anticipated. The drug has now reached day 150 of the decentralised regulatory process (DCP) without any major issues, the only outstanding minor point is the Patient Leaflet:

1. Completion of regulatory documentation for decentralised application (patient information leaflet) with UK as RMS (Reference Member State) and Spain as CMS (Concerned Member State) - April 2010?

2. Closure of decentralised phase April-May 2010?

3. Grant of national licences in UK and Spain (following agreement on local labelling and packaging)- 30 days is standard approval - June 2010
4. Launch in UK - June 2010 (Q2 - company state high confidence of Q2 launch)
5. Start of Spanish reimbursement discussions - June 2010
6. Launch in Spain - September 2010 ( 3 months consultation on pricing)

7. Start of mutual recognition process in other European markets with UK as Reference Member state - July 2010?

8. Grant of mutual recognition in other major European markets (6 month approval normal) - Q1 2011 (possibly end 2010)

In parallel reimbursement discussions will be going on. The company will have submitted a price to the UK's Department of Health and unless there have been significant disagreement, Sativex will be reimbursable on the NHS from product launch. NICE (the National Institure of Clinical Excellence) may assess the drug later and boost uptake with the PCT's (Primary Care Trusts) in England and Wales, since budget holders will have guidance on usage.  In the meantime prescribers may use the drug as they wish and it will be paid by the NHS. In Scotland, the SMC (Scottish Medicines Consortium) needs to pre-approve drugs before launch, but the company should have this well in hand. In Spain, GW's partner Almirall will in discussions with the Spanish Ministry of Health after licence approval, and this is usually a 3 month process. U.K. approval will bring in £10 m from Bayer Schering , and in Spain Almirall will pay £2.5 m on pricing and regulatory approval.

Questions and answers from today's WebCast:

Q. What indication has been approved?

A. Symptomatic improvement  in symptoms of MS who have failed on other anti spasticity medications. 

Q. What territories are planned for Mutual Recognition?

A. GW and Almirall are putting together a list. Major commercial markets included. NICE preparation in hands of Bayer Schering, Market access team who have significant expertise.

Q. Any plans to expand label?

A. No, comfortable with indication.

Q. Is cancer pain trial on track for Spring. 

A. Yes

Q. What are launch logistics?

A. Sufficient launch stock. Manufacturing licence issued in 2009. Launch batches delivered into distribution chain on approval announcement.

Q. Is there capacity to cater for global demand?

A. Yes, capacity will be ramped up using 3rd parties.

Q. What are licensing plans outside Canada, UK, Europe and U.S..

A. Ambition to use the European approval as basis for filing in other parts of world. Distribution partners being discussed e.g. Australia,  Latin America, Africa.Update on rest of world at Interims in May.

Q. What is situation on Spain pricing?

A. Spanish Ministry of Health and Almirall will be in negotiations. Expect 3 months, maybe more.

Q. When are milestone payments due?

A. Milestone payments on reg. and pricing approval in Spain. Licence approval UK

Q. When is Canadian spasticity indication due?

A. Canadian reg. submission for spasticity filed end 2009. H2 2010 outcome. 

Q. Have you considered issue of pricing differentials in different countires?

A. Partners make decision on price. UK will be public domain once Almirall start price discussions. 

Faith in GW Pharma's Sativex drug pays off!

GW Pharma (GWP) released the following RNS this morning which is outstanding news. They key sentence is "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." This means that the efficacy concerns that stopped the previous decentralised European application has been addressed with the regulatory authorities. The company is now at a documentation phase relating to the PIL (patient information leaflet) and packaging artwork. Fantastic news as this is Contrarian Investor UK's  largest holding! 




UK AND SPANISH REGULATORS CONFIRM NO MAJOR ISSUES OUTSTANDING 
Regulatory Process Now at Advanced Stage. Approvals Expected Q2 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 GBP10m milestone payment from Bayer. A further GBP2.5m 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.