CBDWire Editorial Coverage: The backbone of medical advancement is biotechnology, an industry wrought with the incredible potential of novel drug R&D, but vulnerable to the risk of stringent regulatory approval processes. Within this volatile market, however, is the cannabis-biotech sub-sector – a market flourishing with opportunity, innovation, and deep roots of medical possibilities. Fueled by an increasing volume of supportive research, cannabis-based biotech companies are addressing large markets of unmet medical need while rising to meet global demand of epic proportion. Included among several companies in the cannabis-biotech sub-sector is Lexaria Bioscience Corp. (OTCQB: LXRP) (CSE: LXX) (LXRP Profile), a company emerging as a recognizable name within a space occupied by companies like GW Pharmaceuticals PLC (NASDAQ: GWPH), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Insys Therapeutics, Inc. (NASDAQ: INSY) and Axim Biotechnologies Inc. (OTCQB: AXIM).
Because the cannabis-biotech sub-sector remains in relative infancy, it is full of uncharted territory and prospects as companies aggressively explore the medicinal potential of marijuana and the plant’s compounds and applications. Food bioscience company Lexaria Bioscience Corp. (OTCQB: LXRP) (CSE: LXX), for instance, enjoys a unique position in this sub-sector. As the only publicly traded company with a cannabis-based intellectual portfolio that includes NSAIDs, nicotine and vitamins, Lexaria has multiple patents pending in over 40 countries, and it recently received its first patents in the U.S. and Australia relating to edible forms of cannabinoids (http://nnw.fm/e8LvY).
At the center of these patents is the company’s proprietary technology, which improves the delivery of bioactive compounds, primarily cannabinoids, into the human body. While cannabinoids tout great potential for medical treatment, the compounds are poorly absorbed by the gastrointestinal tract. As a result, users frequently turn to alternative administration methods, like smoking, for enhanced effectiveness. Lexaria’s lipophilic enhancement technology, however, demonstrates the ability to boost bioavailability of orally-ingested cannabinoids while at the same time masking their “unusual” taste. This technology is patent-protected for cannabidiol (CBD) and all other non-psychoactive cannabinoids. Other patents are also pending for tetrahydrocannabinol (THC), other psychoactive cannabinoids, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules.
In collaboration with the National Research Council of Canada (“NRC”) (http://nnw.fm/fdG8Z), Lexaria has commenced lab work to study and optimize the application of its technology toward enabling the delivery of lipophilic active agents within foods, beverages, capsules and other ingestible formats. Practical applications of this collaboration could include expansion of Lexaria’s IP portfolio and the possibility of new commercial arrangements. Lexaria currently has two distinct consumer brands that utilize this game-changing technology of infusing hemp oil inside the lipids in foods: ViPova™ and Lexaria Energy.
Introduced in 2015, the ViPova product line began with a Chinese black tea containing hemp oil infused into dried, evaporated nonfat milk. The following year, Lexaria took advantage of the broader beverage market, and ViPova’s product line was expanded to include coffee and hot chocolate. The company sells its ViPova product directly online to consumers.
Lexaria Energy products also utilize the company’s patented infusion technology to deliver federally legal hemp oil ingredients inside nutritious and tasty formulations that are free of the bitter taste typically associated with hemp. Products in this line include the Lexaria Energy Bar, a hemp oil-infused protein bar. Other nutritious products are in development for the Lexaria Energy line, with a focus on ensuring responsible production techniques and gluten-free formulations.
Lexaria also licenses its technology to third-party partners, making royalties an integral part of its overall business strategy and revenue potential as it pursues opportunities to broaden and strengthen its IP portfolio. Because Lexaria’s technology relies on a delivery methodology – and not just a single drug or molecule – even cannabis giants like GW Pharmaceuticals PLC (GWPH) might discover Lexaria’s technology as an effective way to deliver its drug.
GW Pharmaceuticals has become a world leader in developing plant-derived cannabinoid therapeutics by leveraging its established drug discovery and development processes, extensive intellectual property portfolio, and regulatory and manufacturing expertise. The company’s research delves into the potential therapeutic applications of cannabinoids, and GW has evaluated the pharmacology of various cannabinoids across a broad array of disease areas. GW’s focus is chiefly on central nervous system disorders, including epilepsy. The company’s lead product candidate, Epidiolex, is a liquid formulation of pure plant-derived CBD and is in development to treat various rare childhood-onset epilepsy disorders. GW has also commercialized Sativex, the world’s very first plant-derived cannabinoid prescription drug, which has been approved in 29 countries outside the U.S. for the treatment of multiple sclerosis-related spasticity. GW’s pipeline of other cannabinoid product candidates includes compounds in development for treating epilepsy, glioma and schizophrenia.
Another biotech standout in the cannabis market is clinical-stage pharmaceutical company Zynerba Pharmaceuticals, Inc. (ZYNE). Zynerba is focused on the development of innovative transdermal synthetic cannabinoid treatment options for patients with high unmet medical needs. The company’s development pipeline includes two lead product candidates that are being evaluated in five therapeutic indications: ZYN002 and ZYN001. Currently in phase 2 clinical development for refractory epilepsy, osteoarthritis of the knee and Fragile X syndrome, ZYN002 is the first and only synthetic form of CBD and has been formulated as a patent-protected permeation-enhanced gel for transdermal delivery into the circulatory system. ZYN001 is a THC pro-drug that enables transdermal delivery through the skin and into the circulatory system via a patch. A phase 1 clinical program for fibromyalgia and peripheral neuropathic pain was initiated by Zynerba in the first half of 2017.
Specialty pharmaceutical company Insys Therapeutics, Inc. (INSY) is focused on developing and commercializing innovative drugs and novel drug delivery systems for therapeutic molecules with the end goal of improving quality of life for patients. Insys uses proprietary sublingual spray technology along with its pharmaceutical cannabinoid development capabilities to address the clinical inadequacies of existing commercial products. In May 2017, Insys Therapeutics received FDA approval for the final product label of its Syndros (dronabinol) oral solution, marking the last regulatory step needed before the official launch of the product, which is planned to take place sometime in August 2017. Syndros is a liquid formulation of the pharmaceutical cannabinoid dronabinol and has been approved for use in the treatment of weight loss-related anorexia in AIDS patients and nausea and vomiting in chemotherapy patients who are unresponsive to conventional antiemetic treatments. Insys is additionally at the phase 2 clinical development stage for a cannabidiol treatment to address severe pediatric epilepsies.
Biotechnology company Axim Biotechnologies Inc. (OTCQB: AXIM) is a leader in cannabinoid R&D and is striving to set the green standard for cannabinoid bioscience. The company’s most advanced program is its phase 2 clinical trial of CanChew Plus chewing gum to treat irritable bowel syndrome. The company is similarly using a chewing gum-based approach for the treatment of pain, multiple sclerosis spasticity and other indications. CanChew Gum is the world’s first patented, functional chewing gum that is derived from CBD-rich industrial hemp, and it is legal in all 50 states. Axim is additionally conducting research into the use of molecularly-modified cannabinoids as neuroprotectants, as well as the use of industrial hemp-derived formulations of cannabigerol (CBG) for dermatological applications. AXIM is further conducting trials or has products in development targeting a large number of indications, including ADHD, smoking cessation, ulcerative colitis, Crohn’s disease, drug-related psychosis, psoriasis, atopic dermatitis and more. The company is also in the process of developing a unique extraction and freeze-drying technology for producing molecularly/genetically-controlled pharma-grade cannabinoids extracted from industrial hemp.
For biotech investors looking at the legal cannabis sector and interested in potentially taking part of the growth in the broader marijuana industry, the companies described above are all worth keeping on your investment radar. Stay tuned to CBDWire for more public information on investment opportunities and on Lexaria Bioscience.
For more information on Lexaria Bioscience, please visit: Lexaria Bioscience Corp. (LXRP)
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