Britain Approves GW Pharma’s Cannabis Drug Sativex

GW Pharmaceuticals Plc’s cannabis-derived medicine Sativex has been approved in Britain for treating spasticity in patients with multiple sclerosis, in a landmark decision for the small drugmaker.

The much-delayed product was finally granted a British licence on Thursday, an official from the Medicines and Healthcare products Regulatory Agency (MHRA) told Reuters on Friday.

The company later issued a statement confirming the move.

Clinical trials have shown GW’s Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis (MS) in patients who do not respond adequately to existing therapies.

It became the world’s first cannabis medicine to win regulatory clearance when it was approved in Canada in 2005 for neuropathic pain but its roll-out in Britain — and other European markets thereafter — is a larger sales opportunity.

GW and Germany’s Bayer, which will market the drug in Britain, plan to hold a press conference on Sativex on June 21.

A green light from the MHRA had been expected before the end of June but confirmation of approval will still be a relief to investors, who have seen a series of delays with the product.

Shares in the company jumped 11 percent to a four-year high of 143 pence on the news by 1400 GMT.

GW had originally hoped to win approval in 2003 for its drug — which is extracted from marijuana plants grown at secret locations in the English countryside — but the medicine has been hit by a string of regulatory delays in Europe.

GW said last month it also expected a regulatory green light in Spain shortly after the British approval, with other European countries following later.

Sativex will be sold in the rest of Europe outside Britain by Spanish drugmaker Almirall.

GW will receive a 10 million pounds ($15 million) milestone payment from Bayer as a result of British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain.

WILL NHS PAY FOR IT?

Questions remain about Sativex’s commercial potential.

In particular, the rate of uptake in Britain will likely be limited until the National Institute for Health and Clinical Excellence (NICE) decides whether it should be reimbursed on the National Health Service (NHS).

Analysts at Piper Jaffray, which acts as adviser to GW, forecast that peak sales in MS spasticity could reach 121 million pounds in Europe and Canada combined.

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

Shawn Manning, an analyst at Singer Capital Markets, said a green light for cancer pain in the United States would be a major commercial breakthrough.

“That’s a real opportunity, that will be the big market — that’s the real target for this product,” he said.

– Article from Reuters.

Comments

7 Comments

  1. mary james on

    i think it must have been israel, all the other countries are bankrupt now.

  2. David762 on

    The issue raised in England regarding cannabis is a perfect example of Crony Corporatism. Cannabis is illegal only so long as citizens might want to grow it themselves, share it with friends, or use it medically or recreationally. It threatens the status quo of the crony corporations, whether they are liquor distillers, beer brewers, law enforcement and the private prisons industry, or the pharmaceutical companies. If it threatens their bottom line profits, it is evil and must be kept illegal.

    But give a crony corporation and their lackey politicians an opportunity for new profits, through patents and prescriptions, trademarks and taxes, repression and regulation and that is perfectly legal, just like “Sativex(TM)” — Double-Plus-Good …
    This social contract does not benefit the people, only the Corporate State. For their own security and the benefit of the State, citizens are required to yield their personal rights, their liberty, to the State. The State decides what is good or evil, what is beneficial and what is harmful, and who may profit. It is called Fascism, or National Socialism — you know, that monstrous evil that we fought a World War to defeat. Collectively, our governments have embraced those things that we once railed against.

    Who, exactly, won World War 2, again … ?

  3. Anonymous on

    It was just too easy to harvest the herb,dry it and smoke it.GW does not endorse the inhalation by smoke process..So they went to great lenghts to separate the mixture and isolate only the THC.Trouble is it does not work too well.Big Pharma does not understand that the cure in marijuana resides in its unique mixture and combinations of more than 400 chemicals but mostly and mainly thru the unique combination of its cannabinoids content.Looks to them you have to have only 1 compound to be able to make 1 pill.Not so. It is not tomorrow that man will mimics the real herbal marijuana in a pill form.In the meantime smoking offers the best way to medicate with marijuana and much better if you vaporize.

  4. mary james on

    it works for some people but not for others. i understand that it’s basically thc in a solution of alcohol.
    they showed the grow rooms on tv news tonight and the plants were obviously sativa although the vo said they used two varieties. plants were around 10 foot and heavily budded.
    i tried it when it was being trialled and only got a headache but my friend with ms says it helps with his spasticy but not as much as does a spliff.
    i’m personally looking for some of the stuff from the sixties which i’m sure had a healthier proportion of cbn and cbd to thc.

  5. Anonymous on

    THE real target is the $$$500 Million possibly per year? This is Pharmaceutical Co’s abusing drugs!!! Their target is money. THEIR TARGET IS MONEY, MONEY, like every other drug company. THIS PRODUCT IS FAKE, FAKE!!!!

  6. rasta love vibe on

    poly..that’s corporate governance that moves the real policy decisions.I’ll never use artificial myself???

  7. ray christl THC MACHINE on

    x .Yes this a wonderful addition,yet without organic HERO machine,,,well sativa means grown for utility.Sativex sounds sexy ,so must be good!?This only deductively validates all that we do to legalize nature/organic MOM.