Company To Help with Trials on Cannabis Product

Company To Help with Trials on Cannabis Product
Posted by CN Staff on April 10, 2005 at 17:17:31 PT
By Michelle Miron
Source: Kalamazoo Gazette
Michigan -- Kalamazoo's Apjohn Group LLC has been hired to help bring a cannabis-based analgesic drug closer to market by early next year. British biotechnology firm GW Pharmaceuticals recently announced that it will work with Apjohn to gain U.S. approval to do clinical trials on Sativex, an oral spray derived from cannabis or hemp plants.
"We're excited about this one," Apjohn Managing Director Donald R. Parfet said. "They (cannabis-based drugs) were sold as medicinals until the 1930s, and now people are re-evaluating the medicinal effects of cannabis. GW has done a really nice job of advancing the science and medicine associated with it." Because some varieties can be illicitly turned into the psychotropic drug marijuana, the growing of cannabis is illegal in the United States, Great Britain and many other countries. But since 1998, GW has had special permission from the British government to cultivate a form of Cannabis sativa that doesn't contain the active substance that causes intoxication, according to GW Pharmaceuticals' Web site. Sativex has been shown to reduce cancer pain, multiple sclerosis-associated spasticity and other symptoms in patients who do not respond to standard therapies, according to the company. Sativex has achieved preliminary approval in Canada and is still being considered for approval in Great Britain. BayerHealthCare is under contract to market it in both countries. Parfet said confidentiality clauses prohibited him from providing details of what Apjohn has done to help bring the product to market, other than "assisting in the pursuit of an NDA (new drug application) in the U.S." Mark Rogerson, a spokesman for GW, said Apjohn was chosen for its "extensive experience in U.S. clinical development, regulatory affairs and public policy." Cannabis Regulated Asked if there is a controversy or stigma associated with the product, Parfet replied: "Of course everyone has their own bias. But what attracts us is how GW has approached this from a traditional medicine standpoint. We think that our task will be pretty straightforward." A similar drug called Marinol, made by Brussels, Belgium-based Solvay Pharmaceuticals Inc., has an ingredient that is a synthetic or chemically derived version of cannabis, said John J. Abbott, an independent pharmaceutical consultant based in Pittsburgh. Marinol, which achieved 2004 sales of 63 million euros, has been on the U.S. market for the last several years and is used as an analgesic for cancer patients and to reduce blood pressure in the eye in glaucoma patients, according to the Solvay Web site. "There's no question that cannabis is a very analgesic agent," Abbott said. "Most scholars in the field feel that the natural substance is much better than the synthetic, but most people who take it are prescribed Marinol because it (cannabis) is illegal to grow or possess in the U.S." He said Apjohn could face a challenge when it comes to promoting Sativex, since the U.S. government has very strict regulations about narcotic, stimulant or depressant drugs categorized as "CII" that have a high abuse potential. MS, Arthritis TargetedAs a public company, GW doesn't make financial forecasts, Rogerson said, but its target market for Sativex encompasses MS, cancer or rheumatoid-arthritis patients. In the United Kingdom alone, 85,000 people have MS, he said, while in Canada 50,000 have the disease. "MS and rheumatoid arthritis are big markets in both Europe and North America, and cancer pain is a significant problem," he said. "Ten to 20 percent of MS sufferers say they have already experimented with illegal cannabis to treat their symptoms. We think it is a reasonable assumption that many more will wish to take a legal prescription medicine." Abbott said that larger pharmaceutical firms like Pfizer Inc., Merck and Co. Inc. and Abbott Laboratories Inc. don't take on such projects. "Most companies wouldn't get into this area because there's probably not enough money in it for all the work that's going to be involved," he said. "But Apjohn is dealing a lot with 'orphan drugs' in what I would call peripheral situations where they have something unique." Complete Title: Local Company To Help with Trials on Cannabis ProductNewshawk: EkimSource: Kalamazoo Gazette (MI)Author: Michelle MironPublished: Sunday, April 10, 2005Copyright: 2005 Kalamazoo GazetteWebsite: letters kalamazoogazette.comRelated Articles & Web Site:GW Pharmaceuticals Plans U.S. Future for Cannabis Drug Approves Cannabis Drug
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