POT-BASED PRESCRIPTION DRUG LOOKS FOR FDA OK

SAN FRANCISCO -- A quarter-century after the U.S. Food and Drug
Administration approved the first prescription drugs based on the
main psychoactive ingredient in marijuana, additional medicines
derived from or inspired by the cannabis plant itself could soon be
making their way to pharmacy shelves, according to drug companies,
small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the
world's first pharmaceutical developed from raw marijuana instead of
synthetic equivalents- a mouth spray it hopes to market in the U.S.
as a treatment for cancer pain. And it hopes to see FDA approval by
the end of 2013.

Sativex contains marijuana's two best known components - delta 9-THC
and cannabidiol - and already has been approved in Canada, New
Zealand and eight European countries for a different usage, relieving
muscle spasms associated with multiple sclerosis.

FDA approval would represent an important milestone in the nation's
often uneasy relationship with marijuana, which 16 states and the
District of Columbia already allow residents to use legally with
doctors' recommendations. The U.S. Drug Enforcement Administration
categorizes pot as a dangerous drug with no medical value, but the
availability of a chemically similar prescription drug could increase
pressure on the federal government to revisit its position and
encourage other drug companies to follow in GW Pharma's footsteps.

"There is a real disconnect between what the public seems to be
demanding and what the states have pushed for and what the market is
providing," said Aron Lichtman, a Virginia Commonwealth University
pharmacology professor and president of the International Cannabinoid
Research Society. "It seems to me a company with a great deal of
vision would say, 'If there is this demand and need, we could develop
a drug that will help people and we will make a lot of money.'"

Possessing marijuana still is illegal in the United Kingdom, but
about a decade ago GW Pharma's founder, Dr. Geoffrey Guy, received
permission to grow it to develop a prescription drug. Guy proposed
the idea at a scientific conference that heard anecdotal evidence
that pot provides relief to multiple sclerosis patients, and the
British government welcomed it as a potential way "to draw a clear
line between recreational and medicinal use," company spokesman Mark
Rogerson said.

In addition to exploring new applications for Sativex, the company is
developing drugs with different cannabis formulations.

"We were the first ones to charge forward and a lot of people were
watching to see what happened to us," Rogerson said. "I think we are
clearly past that stage."

In 1985, the FDA approved two drug capsules containing synthetic THC,
Marinol and Cesamet, to ease side-effects of chemotherapy in cancer
patients. The agency eventually allowed Marinol to be prescribed to
stimulate the appetites of AIDS patients. The drug's patent expired
last year, and other U.S. companies have been developing formulations
that could be administered through dissolving pills, creams and skin
patches and perhaps be used for other ailments.

Doctors and multiple sclerosis patients are cautiously optimistic
about Sativex. The National Multiple Sclerosis Society has not
endorsed marijuana use by patients, but the organization is
sponsoring a study by a University of California, Davis neurologist
to determine how smoking marijuana compares to Marinol in addressing
painful muscle spasms.

"The cannabinoids and marijuana will, eventually, likely be part of
the clinician's armamentarium, if they are shown to be clinically
beneficial," said Timothy Coetzee, the society's chief research
officer. "The big unknown in my mind is whether they are clearly beneficial."

Opponents and supporters of crude marijuana's effectiveness generally
agree that more research is needed. And marijuana advocates fear that
the government will use any new prescription products to justify a
continued prohibition on marijuana use. .

"To the extent that companies can produce effective medication that
utilizes the components of the plant, that's great. But that should
not be the exclusive access for people who want to be able to use
medical marijuana," Americans for Safe Access spokesman Kris Hermes
said. "That's the race against time, in terms of how quickly can we
put pressure on the federal government to recognize the plant has
medical use versus the government coming out with the magic bullet
pharmaceutical pill."

Interest in new and better marijuana-based medicines has been
building since the discovery in the late 1980s and 1990s that mammals
have receptors in their central nervous systems, several organs and
immune systems for the chemicals in botanical cannabis and that their
bodies also produce natural cannabinoids that work on the same receptors.

One of the first drugs to build on those breakthroughs was an
anti-obesity medication that blocked the same chemical receptors that
trigger the munchies in pot smokers. Under the name Acomplia, it was
approved throughout Europe and heralded as a possible new treatment
for smoking cessation and metabolic disorders that can lead to heart attacks.

The FDA was reviewing its safety as a diet drug when follow-up
studies showed that people taking the drug were at heightened risk of
suicide and other psychiatric disorders. French manufacturer
Sanofi-Aventis, pulled it from the market in late 2008.

Given that drug companies already were reluctant "to touch anything
that is THC-like with a 10-foot-pole," the setback had a chilling
effect on cannabinoid drug development, according to Lichtman.

"Big companies like Merck and Pfizer were developing their own
versions (of Acomplia), so all of those programs they spent millions
and millions on just went away..." he said.

But scientists and drug companies that are exploring pot's promise
predict the path will ultimately be successful, if long and littered
with setbacks.

One is Alexandros Makriyannis, director of the Center for Drug
Discovery at Northeastern University and founder of a small Boston
company that hopes to market synthetic pain products that are
chemically unrelated to marijuana, but work similarly on the body or
inhibit the cannabinoid receptors. He also has been working on a
compound that functions like the failed Acomplia but without the
depressive effects.

"I think within five to 10 years, we should get something," Makriyannis said.