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insights BIOPHARMA LIFESCIENCELEADER.COM NOVEMBER 2014 48 based products to new indications." Finally, determining the appropriate cannabis-dosing regimen for individual therapeutic indications will be critical. Petkanas offered, "Right now we have extremely limited scientific information regarding cannabis-dosing regimens for individual indications. We have to get this right to instill confidence in patients and physicians that our products work and are safe." PROVIDER/INSURANCE EDUCATION IS IMPERATIVE Both Petkanas and Castor agree that the existing confusion about the legal- ity of cannabis-based products will like- ly have an effect on insurers and third party payers. "At this point, it is really unclear whether payers are going to place these drugs on formulary and reimburse patients who use them medicinally," stressed Petkanas. Further, Castor sug- gested that, like the omega 3 fish oil mar- ket, where there are both nutritional sup- plements and omega 3 fatty acid-based prescription drugs, consumers may have to pay out of pocket for medical mari- juana, whereas insurers may cover the cost of FDA-approved cannabis-based therapeutics. Despite any of these challenges, it is undeniable that there is burgeoning demand for medical marijuana and cannabis-based pharmaceuticals in the U.S. However, while the American public appears to be ready for medi- cal cannabis use, it is currently unclear whether physicians will be inclined to write prescriptions for these products. To that point, patient and healthcare pro- vider education was cited by each person interviewed for this article as the single most important factor for successful U.S. commercialization of cannabis-based therapeutics. "Let's face it, if physicians don't understand these drugs and are not convinced that these products are safe and effective, then they certainly are not going to write prescriptions for their patients," emphasized Petkanas. Both Castor and Petkanas believe that can- nabis-based products may garner FDA approval as early as next year. L TECHNICAL/MANUFACTURING CHALLENGES There are also several technical and manufacturing issues that must be addressed before cannabis-based phar- maceuticals can be successfully com- mercialized. First, substantial invest- ment must be made in production facili- ties to breed and grow various cannabis strains to obtain appropriate chemical compositions to treat specific therapeu- tic indications. According to Petkanas, this investment must include research on breeding programs, strain construc- tion, cannabinoid concentrations at dif- ferent stages of plant growth/harvest times, and yield improvements. "As strange as this may sound, crop failure [not having a redundancy of supply] is a serious issue that all players in the medi- cal cannabis industry must address," mentioned Petkanas. Second, plant growth, extraction pro- cesses, and manufacturing active can- nabis-based therapeutics must be con- ducted according to current good manu- facturing practices (cGMP) and rigorous quality standards. "The whole point of seeking regulatory approval is to demon- strate to patients and healthcare provid- ers that our products have been thor- oughly reviewed are well characterized and determined to be safe and effective," stressed GW Pharma's Schultz . Third, the method and route of deliv- ery of cannabis-based pharmaceuticals for individual indications will be vitally important. While smoking cannabis is currently the most obvious method to deliver desired therapeutic effects, it may not be the most effective way to maximize its medicinal benefits. "Every patient is different, and we need to offer them alternate delivery meth- ods to best treat their illnesses," offered Petkanas. He added, "You cannot lock- in on a single delivery technology or form of administration for these prod- ucts." Castor agrees. "We are currently studying various routes of administra- tion and investigating the use of con- trolled-release technology to improve the oral and topical delivery of our products to expand the use of cannabis- cannabis-based products. He said, "The legal patchwork for cannabis that has evolved in the U.S. suggests that canna- bis-based therapeutics will be available only in certain states (which will restrict patient access) and also make it very costly for companies to underwrite prod- uct launches in individual states." Unlike other prescription drugs, which are exclusively in the purview of the FDA, cannabis-based therapeutics require input from the U.S. Drug Enforcement Agency (DEA). And, the current politi- cal mindset at the DEA is not favor- able for the current and future develop- ment of cannabis-based products. "THC is the only cannabinoid that has any real psychotropic effects, and, despite the possible therapeutic benefits of other cannabinoids like CBD and CBG, they are Schedule I substances, which makes developing any cannabis-based pharmaceuticals quite challenging," lamented Castor. Petkanas was more sanguine about cannabis's designation as a Schedule I substance. He said, "The Controlled Substance Act needs to be repealed, changed, or simply allowed to wither away to ensure that much needed cannabis-based drugs can be brought to market to address unmet medical needs." By C. Mintz CANNABIS-BASED PHARMACEUTIALS: THE NEXT FRONTIER? The market is large enough to support both the nutraceutical/herbal remedies and pharmaceutical sides of the business. T R E V O R C A S T O R CEO of Aphios Corp.