2ND SYNTHETIC MARIJUANA DRUG OK'D TO TREAT CHEMO EFFECTS

Cesamet Joins Marinol In June

The maker of a synthetic drug similar to the active ingredient in
marijuana said Tuesday that it had received Food and Drug
Administration approval for U.S. sales.

Cesamet, a second-line treatment for nausea and vomiting resulting
from chemotherapy, will become the second cannabinoid pill in the USA.

A second-line treatment is used when cancer patients don't respond to
conventional drugs. Cannabinoid is a chemical compound in marijuana.

In Canada, where Cesamet has been sold since 1981, the drug has an
88% share of the cannabinoid market, says Wes Wheeler, president of
North America Global Commercial Development for Valeant
Pharmaceuticals International, maker of Cesamet. Cesamet is expected
to arrive in U.S. drugstores next month.

About half a million Americans receive chemotherapy each year, and
about 70% to 80% experience serious side effects, Wheeler says. About
20% don't respond to conventional treatments, such as Zofran, for
nausea and vomiting, which makes them candidates for Cesamet, Wheeler says.

In clinical trials, patients had at least one side effect, such as
drowsiness, dizziness and euphoria, from using Cesamet. Because of
its abuse potential, Cesamet is a Schedule II controlled substance,
which means prescriptions can't be refilled.

The FDA first approved Cesamet in 1985, and it was marketed for four
years by Eli Lilly. For business, not safety, reasons, Lilly decided
to discontinue the drug. Valeant bought the Canadian rights in 2001
and the U.S. rights in 2004, Wheeler says.

Valeant did not need to do any additional clinical trials, but it did
have to get FDA approval for its Montreal manufacturing plant and
revise Cesamet's label to meet current FDA standards, Wheeler says.

The other cannabinoid sold in the USA and Canada is Solvay
Pharmaceutical's Marinol, which is approved as a second-line
treatment for chemotherapy-induced nausea and vomiting as well as an
appetite stimulant in AIDS patients. Marinol is a synthetic version
of THC, the active ingredient in marijuana. Cesamet is a synthetic
cannabinoid that is similar to THC.

Cesamet and Marinol will be competitively priced. Wheeler and Solvay
spokesman Michael Lourie say the drugs cost about $30 a day.

A third related product, Savitex, won Canadian approval last year for
treating pain from multiple sclerosis. Savitex is a mouth spray
containing an extract of marijuana plants grown by GW
Pharmaceuticals, a British company. GW spokesman Mark Rogerson said
Tuesday the FDA has OK'd plans to conduct Savitex clinical trials as
GW considers entering the U.S. market.

Cannabinoids taken by mouth begin working more slowly and are
absorbed more erratically than inhaled marijuana, so many patients
prefer the latter, University of Montreal pharmacologist Mohamed Ben
Amar wrote in a paper posted in March by the Journal of
Ethnopharmacology. But an FDA statement last month said no sound
scientific studies support the medical use of marijuana.