FIRM HELPS GET MARIJUANA-BASED DRUG INTO TRIALS

A cannabis-derived painkiller will undergo Phase III clinical trials
in the United States beginning later this year, partly because of
help from Kalamazoo life-sciences consulting firm Apjohn Group LLC.

The prescription drug, Sativex, was approved in January by the U.S.
Food and Drug Administration for the Phase III trials, which
represent the last stage of clinical research required before a
company can apply for license to market.

The oral analgesic spray is produced by British technology firm GW
Pharmaceuticals and is already being marketed in Canada by Bayer.

Apjohn, the firm started in 2003 by former Pharmacia Corp. executive
Donald Parfet and others, was hired by GW in early 2005 to help bring
the drug closer to U.S. clinical trials.

"Apjohn played an extremely important role in helping GW prepare the
documentation for the Investigational New Drug Application," said
Mark Rogerson, GW's press and public-relations representative.
"(That) led to a very successful result from the Food and Drug
Administration -- the agency's allowing us to go directly into
pivotal Phase III trials."

The drug is the first commercial cannabis (marijuana) -derived drug
in the world. It's used in Canada to treat patients with multiple
sclerosis, and current trials are targeted at patients with advanced
cancer whose pain has not been relieved by opioid medications like
morphine, according to GW.

More than 2,000 patients and subjects have been involved in Sativex
clinical trials in Europe and elsewhere, Rogerson said. The drug was
also recently approved for limited use in Spain.

GW projects that an application to market Sativex in the U.S. could
be submitted within 24 to 36 months after U.S. trials begin.

"The time scale after that is up to the FDA," Rogerson said.

GW was founded in 1998 and also focuses on cannabis-derived
pharmaceuticals for patients with spinal-cord injuries, rheumatoid
arthritis, neuropathic pain and other conditions. Its operations
encompass botanical research, cultivation, extraction, formulation
and medication delivery.