UK: Late again: GW's cannabis-based painkiller

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Heather Stewart

The Guardian

Saturday 01 May 2004

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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 UKP10m to UKP15m "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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