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GW pharma shares flying high after stellar results for epilepsy drug * 2
    #23389718 - 06/28/16 12:53 AM (7 years, 6 months ago)

http://www.telegraph.co.uk/business/2016/06/27/gw-pharma-shares-flying-high-after-stellar-results-for-epilepsy/

Quote:

27 June 2016



A British biotech that develops drugs derived from the cannabis plant has unveiled stellar results from late-stage trials testing its key mediation on children with severe, untreatable epilepsy, sending shares in the company soaring by 25pc.

Justin Gover, chief executive of UK-listed GW Pharmaceuticals, said results from the phase three study showed that Epidiolex significantly reduced the number of seizures in patients suffering from Lennox-Gastaut Syndrome, a severe, drug-resistant form of childhood epilepsy.

During the treatment period, patients taking Epidiolex achieved a median reduction in monthly seizures of 44pc compared with a reduction of 22pc in patients receiving placebo.



"These are kids who, on average this was the tenth drug they had tried," Mr Gover said. "They were having on average 74 drop seizures a month, which are episodes where they jerk and shake and fall down, so to have a medicine that has a potential to provide a new way of treating these patients is important and incredibly exciting for the company."

The news comes just three months after the company reported equally positive results in phase three trials testing Epidiolex on patients with Dravet Syndrome, another form of childhood epilepsy.

"It’s fabulous," Mr Gover said. "March was a breakthrough moment, but these results take us to a different place and to have a second study to be so robustly positive and consistent with the first, shows that it was no fluke.

"It also means that the level of confidence we have in this product being filed with the US regulators and getting approved goes up another level."


Epidiolex on the assembly line

GW Pharmaceuticals will file with the US Food and Drug Administration in early 2017 and hopes to win approval towards the end of that year. A European filing will follow in 2018.

Mr Gover said Britain's departure from the European Union "doesn't mean very much" for GW Pharmaceuticals.

"We don’t rely on EU funding, we are a British company and proudly British," he said. "We have a significant UK workforce which will remain. The Patent Box and R&D tax credit system we benefit from are UK policies, so unaffected by the EU, so we don't see Brexit having a material impact."

If the UK were to be kicked out of the European Medicines Agency (EMA), the pan-European drug regulatory body, Britain would have to make its Medicines & Healthcare products Regulatory Agency (MHRA), which currently operates under the umbrella of the EMA, independent from its EU parent. That means GW would have to file two applications, instead of one.


Offering hope to children with seizures

"I don’t think that is a problem," Mr Gover said. "Our earlier drug, Sativex, went through a country by country regulatory process in the EU anyway, so we are used to having direct discussions with the MHRA."

Over the next few months, GW Pharmaceuticals will step up its commercial operations even further as it "aggressively plans to execute the launch" of Epidiolex onto the US market.

Julian Gangolli, whom Mr Gover poached from Allergan a year ago to head up the company's North America business, has been tasked with bulking up the commercial team in preparation for launch.

"It's great that as a biotech company we have moved from early drug discovery, through to late-stage trials, and now hopefully approval and launch, with a product that we fully own," Mr Gover said.

GW has spent more than a decade working out the medical properties of the compounds found in the cannabis plant.

Scientists believe that cannabis contains hundreds of compounds, or cannabinoids, that hold medicinal properties. To date, around 60 of these have been identified.

GW already has one cannabis-derived drug on the market, Sativex, which is approved for the treatment of multiple sclerosis in 28 countries outside the US, including the UK.

The company is also testing cannabis-based products in a number of other clinical areas, including autism spectrum disorders, duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers, and schizophrenia.





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OfflineKonyap

Registered: 06/30/07
Posts: 33,945
Loc: Planet Piss
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Re: GW pharma shares flying high after stellar results for epilepsy drug [Re: Mostly_Harmless]
    #23391357 - 06/28/16 03:15 PM (7 years, 6 months ago)

If it's from weed but isn't weed then.. duh..


Edited by Konyap (06/28/16 03:41 PM)


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