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News (Media Awareness Project) - UK: Late Again: GW's Cannabis-Based Painkiller
Title:UK: Late Again: GW's Cannabis-Based Painkiller
Published On:2004-05-01
Source:Guardian, The (UK)
Fetched On:2008-01-18 11:16:57
LATE AGAIN: GW'S CANNABIS-BASED PAINKILLER

GW Pharmaceuticals, the firm founded to make medicines from cannabis, warned
yesterday that government approval for its first product, a pain-killing
mouth spray, had been delayed for a second time.

Sativex, which it hopes to market to sufferers of multiple sclerosis, will
not win a regulatory thumbs-up until at least the second half of the year,
GW said, causing its share price to slide by more than 20%.

GW had originally hoped to get Sativex approved by the end of last year, and
then set this June as a deadline. Geoffrey Guy, GW's executive chairman,
said yesterday he was still confident it would be approved but refused to
set a new target date. "I've already got it wrong twice," he said. GW's
shares hit a 16-month low of 139.5p after the news.

Mr Guy said GW was in discussions with the Modern Humanities Research
Association, the body which regulates drugs in the UK. He blamed the
unconventional, plant-based nature of the drug for the drawn-out process.
"They are being very diligent and doing a very comprehensive review," he
said. "It's a test case."

GW has a marketing agreement with Bayer for the drug in the UK and Canada,
and is due to receive a ?10m to ?15m "milestone payment" from the German
drug group when it is passed by the MHRA. But Mr Guy said yesterday he was
not in danger of running out of cash despite the hold-up. "There's no change
in the fundamental investment thesis and the underlying strength of the
company," he said.

Sativex is delivered via mouth-spray so that patients do not swallow the
drug and end up in the same state as people who smoke it. "They're seeing
the benefit without getting stoned," Mr Guy explained.

The Home Office granted GW a licence to grow cannabis for research purposes
at a secret site in 1998. The firm has also developed an "advanced
dispensing system", activated with a pin code, to control the use of the
drug. The government is investigating using the system to dispense methadone
to heroin addicts.

Mr Guy stressed yesterday that it was not the safety of Sativex that was
spooking the regulators - and said that he had had more than 4,000 letters
from multiple sclerosis sufferers and other patients keen to see if a
cannabis-based product could help them.

"It's a relatively safe medicine. Many of the patients who receive these
medicines are already receiving strong drugs, often narcotics," he said.
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