UPDATE 1-GW Pharma's cannabis drug to cost 11 pounds a day

* Sativex 125 pounds per 10 ml vial, or about 11 pounds/day

* Bayer to market GW’s cannabis spray in Britain

* Treats spasticity in patients with multiple sclerosis

* GW Pharma shares down 2.1 pct after touching 4-year high

(Adds comments by CEO, analyst; share price)

By Ben Hirschler and Paul Sandle

LONDON, June 21 (Reuters) - GW Pharmaceuticals Plc's GWP.L cannabis-derived medicine Sativex will cost approximately 11 pounds ($16.3) a day when used as a prescription treatment in Britain for spasticity in patients with multiple sclerosis.

Announcing its launch in Britain on Monday, GW said the National Health Service (NHS) price would be 125 pounds for a 10 millilitre vial -- enough to last the average patient just over 11 days.

Sativex, which is sprayed under the tongue, is being launched in Britain by its licensee Bayer AG BAYGn.DE, following its approval late last week. [ID:nLDE65H1C9]

The product’s approval and launch had been well flagged by the company but the news is nonetheless a relief for investors after 11 years of development and a history of previous delays.

“It’s the first new treatment for spasticity in MS for over two decades, and it’s a product we know patients have long been seeking” GW’s managing director, Justin Gover, said in an interview on Monday.

GW shares hit a four-year high of 156 pence but reversed the gains and were down 2.1 percent at 138 pence by 0934 GMT.

Analyst Shawn Manning at Singer Capital Markets said GW had achieved what many of its peers had not in taking a proprietary compound from laboratory to market, but he was cautious on sales potential in Europe, and downgraded the firm to “fair value” from ” buy” with a price target of 137 pence.

“Going forward a key driver of valuation in our GW Pharma model is successful development and launch of Sativex for cancer pain,” he said.

GW will receive a 10 million pounds milestone payment from Bayer as a result of British approval.

The next hurdle for GW and Bayer will be convincing Britain’s National Institute for Health and Clinical Excellence (NICE) that Sativex is a cost-effective treatment for use on the NHS. Until that happens, its sales may be slow, analysts say.

Gover said doctors might be able to prescribe the drug under revised guidelines for treating MS. “It’s quite possible that Sativex will be included within these new guidelines, so a NICE referral for Sativex would not be necessary,” he said.

Outside Britain, the drug is expected to win a regulatory green light in Spain shortly, with other European countries following later. Sativex will be sold in the rest of Europe by Spanish drugmaker Almirall ALM.MC.


Sativex is primarily made up of two cannabinoids extracted from marijuana -- cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).

THC causes the euphoric effect, or “high”, people get from smoking cannabis leaves or resin, but this side-effect is suppressed by the composition and delivery method of Sativex.

Sativex became the world’s first medicine derived from whole plant extracts from the cannabis sativa plant to win regulatory clearance when Canada approved it in 2005 for neuropathic pain.

It is effective in treating muscle stiffness and spasms in about half of patients not benefiting from current therapies -- about 6,000 people in the UK, Gover said.

Analysts at Piper Jaffray, which advises GW, say peak sales in MS spasticity could hit 121 million pounds in Europe and Canada combined. KBC Peel Hunt’s Paul Cuddon and Nomura Code’s Samir Devani see only 50 million pounds of European sales.

The drug could also be used longer term to help treat cancer pain worldwide, opening up a market potentially worth over $500 million in annual sales, according to analysts. But marketing approval for this second use is not expected before 2013.

Gover said the company was researching 12 other primary cannabinoids, which could lead to treatments for tumours, epilepsy and psychotic conditions like schizophrenia. (Editing by Michael Shields))


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