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. 

GW PHARMA FINALLY STARTS MOVE UP ON POTENTIAL SATIVEX NEWS

GW pharma (GWP), developer of the Sativex cannabis spray for pain and spasticity in multiple sclerosis, has finally started moving up. After a 6% rise yesterday, the stock rose 5% today.  Rumours are rife that approval for Sativex by the European regulatory body is close. Contrarian Investor UK, awaits tomorrow with interest as GWP is the portfolio's largest holding and is now showing a healthy profit. But I have no intention of selling before approval when I expect a 35%+ share price rise.

GW pharma partner Almirall hints at Sativex approval timing of Q1 2010

From pipelinereview.com (February 25th 2010):


Following publication of Spanish company Almirall's 2009 results today:


"The regulatory filing of Sativex® for the treatment of spasticity due to multiple sclerosis was submitted in UK and Spain under the European decentralised procedure, following the announcement of positive results in a phase III study where Sativex® showed relevant improvement in spasticity in multiple sclerosis patients. It is expected that the outcome of the regulatory submission will be known during the first quarter of 2010. Following potential approval in the UK and Spain, submissions for approval would be made in other European countries during 2010 under the mutual recognition procedure. Development of Sativex® for oncological pain in ongoing with results from an ongoing phase II/III study expected mid 2010."


"Silodosin (a licensed product from Recordati for use in the treatment of benign prostatic hyperplasia) was recently approved by the European Comission and we expect the regulatory outcome from Sativex® (used in the treatment of spasticity in multiple sclerosis) during this first quarter of 2010. Pending pricing and reimbursement processes, both products could generate sales in 2010, and could contribute to sustain the base business in the years to come."


"Free Cash Flow has reached € 206,4 mill despite the acquisition of linaclotide European rights (US$ 40 Mill downpayment + US$15 Mill of equity following positive phase III CC data) and milestone payments to GW Pharma (GBP 8 Mill) after the positive Phase III and continued regulatory progress of Sativex®"

GW PHARMA (GWP) - Lead drug approval close to fruition

ABOUT GW PHARMACEUTICALS

GW Pharmaceuticals (GWP) was founded in 1998 and listed on AIM, a market of the London Stock Exchange, in June 2001. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines, including Sativex® Spray. In 1999 GWP commenced its first clinical trials evaluating different cannabinoid formulations as potential treatments in the fields of Multiple Sclerosis and pain. GW focused on the development of Sativex, an oromucosal spray with two principal cannabinoid components, Cannabidiol (CBD) and Delta-9 Tetrahydrocannabinol (THC). Since 1999, the safety and efficacy of Sativex has been studied in over 20 randomised placebo-controlled trials in over 3,000 patients. In 2003, GW entered into its first pharmaceutical licence agreement with Bayer Healthcare AG for the UK marketing rights to Sativex. This agreement was expanded to include Canada later that year. In 2005, GW and Almirall signed a licence agreement granting Almirall exclusive marketing rights to Sativex in Europe (ex-UK). In 2007, GW granted Otsuka the US development and marketing rights to the product.

Sativex was first approved in Canada in 2005 under Health Canada’s Notice of Compliance with conditions (NOC/c) policy for the treatment of neuropathic pain in MS. This approval was extended to cancer pain in 2007. In May 2009, a licence submission was made for Sativex in the UK and Spain for the treatment of MS spasticity. In the United States, the FDA granted a Phase III IND (permission to enter Phase III trials) for Sativex in 2006. A US-focused Phase IIb/III trial in cancer pain is currently ongoing.

SATIVEX APPROVAL IN EUROPE

GW Pharma submitted the European regulatory submission for Sativex for the treatment of spasticity due to Multiple Sclerosis on 20th May 2009. The UK regulatory authority (MHRA) in effect sponsored the application as RMS (Reference Member State). The application is being progressed through the DCP (Decentralised Procedure) which allows simultaneous approval in all EU member states once the paperwork for a MRP (Mutual Recognition Procedure) has been fully approved.

The DCP procedure timings are as follows: "The applicant requests one country to be the Reference Member State (RMS) in the procedure. After 70 days the RMS circulates the first Draft assessment report. The Concerned Member States (CMS) and the applicant can then make their comments. On the 120th day of the assessment procedure, the RMS circulates another Draft assessment report, including comments on the SPC, package leaflet and labelling texts. There is also a Mutual Recognition Procedure during the next 90 days, in which other Member States generally adopt the RMS's assessment, unless they have important objections on the grounds of a potentially serious risk to public health. In such situations, further discussions will also be held in the Coordination group for Mutual recognition and Decentralised procedures (CMD(h)). Once a positive opinion on products has been taken in the Mutual recognition and Decentralised procedure, translations of the SPC, package leaflet and labelling texts are submitted and a national marketing authorisation is issued"

So 210 days from 20th May is 16th December 2009. Approval will be pushed back as the company receives questions (which stops the regulatory clock) and sends in responses. Given the strong phase III clinical trial data, it certainly looks likely that Sativex approval will be granted by March 2010 in the U.K. and Spain and in the rest of Europe by the second half of 2010.

INVESTMENT CASE

Buy initiated at 84.5p. A likely positive outcome for Sativex approval within a 3 month time frame  backed up by a good package of large scale clinical studies plus the backing of 3rd party players such as Bayer makes GW pharma a long play.