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INSIGHTS BIOPHARMA LIFESCIENCELEADER.COM NOVEMBER 2014 46 T The current U.S. legal/regulatory landscape has given rise to two distinct types of companies that are attempting to commercialize cannabis products. The first of these is commonly referred to as medical marijuana companies, or as Steven Schultz, VP of investor relations at GW Pharma suggested, "nutraceutical or herbal remedy companies that promote the medicinal properties of cannabis." ypically, products from these companies are botanical extracts or actual plant materi- als derived from specific can- nabis strains with anecdotally-reported medicinal properties that can be topically applied, ingested, smoked, or vaporized. Patients require a prescription from a licensed physician to obtain medical mari- juana, and it can be used only in states that permit consumption of cannabis for medical purposes. Interstate transport of medical marijuana (even between states with medical cannabis legislation in place) is prohibited by federal law. Unlike medical marijuana companies, biopharmaceutical companies, including GW Pharma, Kannalife Sciences, Aphios, and others, are committed to developing cannabis-derived pharmaceuticals using conventional U.S. FDA regulatory approval pathways. "The idea behind our approach is to offer the market, and more impor- tantly patients, a medicine that has been through a full regulatory review and is well characterized regarding efficacy, safety, and interactions with other drugs," offered GW Pharma's Schultz. He added, "None of those things are present in medical mari- juana offerings." Likewise, Dean Petkanas, CEO of New York-based Kannalife Sciences, a phyto- medical company that is developing cannabis-based drugs to treat hepatic encephalopathy and other neurological disorders, said, "Doctors want to know what they are prescribing to their patients and anecdotal evidence about the thera- peutic benefits of a plant-based nutraceu- tical grown by 'new-age-pot-farmer-wan- na-be-pharmacists' is simply not going to cut it. Also, added Petkanas, "In the case of some intractable diseases, there will be a need for extremely potent pharmaceutical cannabis-based products, which normally cannot be achieved using even the best plant-based extraction technologies." While the business case for develop- ing pharmaceutical cannabis-based drugs is sound, the cost and time required for regulatory approval of these products will be much greater than those required for commercializing medical marijuana products. Put simply, medical marijuana products will be commercialized first and likely garner an early majority share of the rapidly emerging medical cannabis market. "Not to worry," offered Trevor Castor, CEO of Boston-based Aphios Corp., a biopharmaceutical company develop- ing cannabinoid-based products to treat emesis (nausea and vomiting), cachexia (wasting diseases), and CNS disorders like MS and Alzheimer's disease, "the market is large enough to support both the nutra- ceutical/herbal remedies and pharmaceu- tical sides of the business. They can easily coexist in today's marketplace." Further, by way of an example, Castor pointed out that the multibillion-dollar omega 3 fatty acids market comfortably supports the sale of both dietary supplements and FDA-approved, prescription-only omega 3-based pharmaceutical products. Unlike most companies in the canna- bis-based pharmaceutical space (mainly focused on developing cannabinoids as therapeutics), Potbotics is a biotechnology company that has combined robotics and artificial intelligence to ostensibly stream- line cannabis pharmaceutical develop- ment. The company is commercializing a product called Brainbot, a physician-facing tool designed to identify the right combina- C L I F F M I N T Z Contributing Editor Cannabis-Based Pharmaceuticals: The Next Frontier? By C. Mintz CANNABIS-BASED PHARMACEUTIALS: THE NEXT FRONTIER?