Pubdate: Fri, 18 May 2001
Source: Business Week (US)
Copyright: 2001 The McGraw-Hill Companies, Inc
Contact:  http://www.businessweek.com/
Details: http://www.mapinc.org/media/753
Author: Carol Matlack

PRESCRIPTION POT: MORE THAN A PIPE DREAM?

The Supreme Court's Ruling Against Medicinal Marijuana Isn't Chilling A 
British Drugmaker's Plans To Test An Oral Spray In The U.s.

That Supreme Court ruling against the medical use of marijuana wasn't a 
total downer for those who want the weed made legal for treating pain and 
other ailments. GW Pharmaceuticals, a British company that's developing 
medications derived from marijuana, says it's pushing ahead with plans to 
start clinical trials in the U.S., with an eye toward bringing the world's 
first cannabis-based prescription drug onto the market as early as 2003. In 
fact, the company announced plans for an initial public offering on May 14, 
only hours before the high court issued its decision.

Geoffrey Guy, founder and chairman of GW Pharmaceuticals, says the ruling 
won't affect his company because it's developing "legal pharmaceutical 
products" that will be reviewed by government regulators. The Supreme Court 
struck down a California law that let marijuana "buyers' cooperatives" 
provide the drug to seriously ill people whose doctors say they could 
benefit from smoking it. The Court said there was no proof of marijuana's 
medical effectiveness -- and Guy agrees. "The 'evidence' has yet to be 
proved," he says. "That is why we are having clinical trials."

"POLITICALLY SENSITIVE."  Under license from the British government, GW 
grows about 15 tons of marijuana a year at secret locations around the 
country, then processes it into medicines intended to provide relief from 
pain and other symptoms. Advanced clinical trials are already under way in 
Britain for one marijuana-based preparation that has shown promise in early 
trials for treating symptoms of multiple sclerosis. Canadian regulators 
recently approved clinical trials there, too. And Guy says GW is in talks 
with the U.S. Food & Drug Administration and Drug Enforcement Agency to 
begin trials in the U.S. Although he expects to get the go-ahead, Guy 
recognizes, "it's more politically sensitive in the United States."

A movement to legalize marijuana for medical use has gained momentum in 
recent years as doctors and patients have reported that the drug eases 
pain, tremors, and muscle spasms caused by nervous-system diseases such as 
multiple sclerosis, as well as nausea caused by chemotherapy and AIDS. 
Voters in eight U.S. states have passed ballot initiatives allowing 
patients to obtain marijuana legally if their doctors certify that it's 
medically necessary. The California law struck down by the Supreme Court, 
for example, allowed state-regulated buyers' cooperatives to distribute the 
drug.

But researchers still aren't certain if tetrahydrocannabinol (THC), the 
active ingredient in marijuana, actually relieves symptoms -- or if people 
simply care less about them when they get high. For now, the Supreme Court 
ruled, marijuana "has no currently accepted medical use in treatment in the 
United States." The FDA has approved Marinol, a drug based on a synthetic 
version of THC, the active ingredient in marijuana. But Marinol's only 
approved use is for treating nausea, and its effectiveness is limited 
because it comes in pills, which nauseated patients often have trouble 
keeping down.

EARLY PROMISE.  Enter GW Pharmaceuticals. The preparations it's developing 
are sprayed under the tongue, so they're absorbed directly into the body 
without the patient having to swallow anything. And the drugs are made from 
processed marijuana, so it doesn't produce a high. Early clinical trials 
over the past two years in Britain have shown effectiveness in treating 
symptoms of multiple sclerosis, arthritis, and cancer.

GW has already raised nearly $15 million from investors since its founding 
in 1997. The company is planning a London stock market listing in late June 
that could value it as high as $240 million. Proceeds will be used to fund 
clinical trials and step up cannabis production to as much as 100 tons a 
year. GW says it expects to be profitable as early as 2004. And it's way 
ahead of the competition: Guy says it's the only company in the world 
legally producing the weed for pharmaceutical uses. So, at least investors 
may be able to get a buzz. But for now, medical-marijuana use awaits the 
outcome of clinical trials.
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MAP posted-by: Beth