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 The study of GW's Epidiolex in Dravet syndrome is the first of four
final-stage Phase III epilepsy trials, with results expected this
year, that the drugmaker hopes will confirm the therapeutic benefits
of cannabinoids, the active ingredients found in marijuana.
GW said on Monday the 120-patient trial showed patients taking
Epidiolex achieved a median reduction in monthly convulsive seizures
of 39 percent compared with a reduction on placebo of 13 percent.
The difference was highly statistically significant and optimism
about the drug's future sales sent shares in GW up 125 percent by
1230 GMT.
"This shows that cannabinoids can produce compelling and clinical
important data and represent a highly promising new class of
medications, hopefully in a range of conditions," Chief Executive
Justin Gover told Reuters.
In light of the positive data, Gover said GW would now request a
meeting with the U.S. Food and Drug Administration (FDA) to discuss
its plans to seek regulatory approval for treating this particular
form of epilepsy.
There are currently no FDA-approved therapies for Dravet syndrome.
Epidiolex, which is given as a child-friendly syrup, is also being
tested in Phase III trials for another rare type of epilepsy called
Lennox-Gastaut syndrome, with results due this year, and a
late-stage study in a third epilepsy indication, tuberous sclerosis
complex, is due to start soon.
Analysts, on average, believe the drug could generate annual sales
of $1.1 billion by 2021, according to consensus forecasts compiled
by Thomson Reuters Cortellis.
CANNABIS PLANTS
GW was founded in 1998 with the aim of capitalizing on the medical
benefits of cannabis, while purifying the active ingredients so as
to avoid psychoactive effects.
Its multiple sclerosis treatment Sativex, which is sprayed under the
tongue and is distributed by marketing partners, already has
regulatory approval in more than 20 countries, although not the
United States.
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Epidiolex, however, is commercially far more significant since GW
retains full control of the product and the company has also geared
the medicine's development to the big U.S. marketplace.
Hopes for the new drug have been building following positive
feedback from "compassionate access" programs involving hundreds of
American children, but the Phase III program is the make-or-break
hurdle.
Gover said the success of the first Phase III trial signaled that
the access programs had painted an accurate picture of the drug's
efficacy.
"It clearly provides us with an excellent basis to be confident
about the outcome of the additional trials because this trial has
shown that the previous open-label data was very predictive," he
said.
GW has strong British roots, with a government license to grow
cannabis plants for its medicines in southern England. But it has
had a rocky time on the London stock market over the years and in
2013 opted for a dual listing on Nasdaq, where it raised nearly $500
million from U.S. investors.
Following a roller-coaster ride for the shares in the past couple of
years, Monday's stock surge values the group at around 1.3 billion
pounds ($1.9 billion).
($1 = 0.6968 pounds)
(Editing by Jane Merriman and Susan Thomas)
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