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UPDATE 1-Third win for cannabis drug in epilepsy sends GW to record high

Mon, 26th Sep 2016 13:06

* Epidiolex cuts seizures in latest LGS clinical study

* GW expects to file for U.S. approval in first half 2017

* Reuters previously reported GW received bid interest (Adds analyst comment and further details, updates shares)

By Natalie Grover and Ben Hirschler

Sept 26 (Reuters) - An experimental cannabis-derived drughas successfully treated children with severe epilepsy in athird late-stage clinical trial, sending shares in Britain's GWPharmaceuticals to a record high on Monday.

GW, which was founded in 1998 to capitalise on the medicalbenefits of cannabis, said it now expected to submit a marketingapplication for Epidiolex to the U.S. Food and DrugAdministration in the first half of 2017.

Its multiple sclerosis treatment Sativex, which is sprayedunder the tongue, is already distributed by marketing partnersin more than 20 countries, but not in the United States.

If Epidiolex is approved, it could become the firstU.S.-approved prescription to be extracted from cannabis. Itcontains cannabidiol, a component of cannabis that does not makepeople high, and is administered as a child-friendly syrup.

Its commercial potential has attracted possible acquirers ofGW, according to people familiar with the matter. Reutersreported earlier this month that GW was working with aninvestment bank after other drugmakers approached it to expressinterest in an acquisition.

Morgan Stanley analyst Andrew Berens said the latestpositive trial results would further de-risk the Epidiolexdevelopment programme.

GW has strong British roots, with a government licence togrow cannabis plants for its medicines in southern England. In2013 it also listed its shares on Nasdaq.

Investors view Epidiolex as critical to GW's future andhopes have been building following positive feedback from"compassionate access" programmes involving hundreds of Americanchildren. Its Phase III trials, however, are make-or-break.

In the latest trial, both tested doses of Epidiolex werefound to have induced a statistically significant improvement inreducing seizures in patients with Lennox-Gastaut syndrome(LGS), GW said.

LGS is a disease that is characterized by seizures, impairedintellectual functioning, developmental delays and behaviouraldisturbances.

The drug had already succeeded in another late-stage studyin LGS and GW has also announced positive results froma late-stage study on patients with Dravet syndrome, anothersevere form of epilepsy.

The company's shares rose as much as 16 percent to hit arecord high of 811 pence on the London Stock Exchange. They weretrading 10 percent higher at 770p by 1255 GMT. (Editing by Savio D'Souza and Mark Potter)

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19 Oct 2016 08:20

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26 Sep 2016 12:57

GW Pharmaceuticals nears US new drug application for epilepsy drug

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7 Sep 2016 19:56

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11 Aug 2016 17:07

UPDATE 2-U.S. agency denies petition to reclassify marijuana

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9 Aug 2016 15:25

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GW Pharmaceuticals Prices ADS Offering, Raising USD252 Million (ALLISS)

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