How Biosynthesis is Revolutionizing Cannabinoid Pharmaceuticals

NEW YORK, October 24, 2017 /PRNewswire/ --

The potential of cannabis for the treatment of an array of medical conditions is a hot topic, and, while many states in America have legalized the use of marijuana in one form or another, the Food and Drug Administration (FDA) is loath to approve drugs from this source. The FDA has concerns with the consistency of drugs extracted from marijuana, and current Good Manufacturing Practices (GMP) regulations are difficult to implement with naturally-sourced products, dissuading most pharmaceutical companies from pursuing this avenue. A possible solution to the FDA's concern with quality and consistency lies in the biosynthesis of cannabinoids. Biosynthesis gives manufacturers the ability to produce a high-quality and consistent active ingredient every time, eliminating concerns of crop variability and pesticide contaminants while greatly reducing cost. InMed Pharmaceuticals, Inc. (CSE: IN) (OTC: IMLFF) (IMLFF Profile) stands out as a unique biotech drug development company in this regard, positioning it among the ranks of bigger companies like Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), a clinical-stage pharmaceutical company developing proprietary synthetic (chemistry-based) cannabinoid treatments for transdermal delivery, and GW Pharmaceuticals plc (NASDAQ: GWPH), which is also at the forefront of pre-clinical research and development of cannabinoids that are extracted from plants. Canopy Growth Corp. (OTC: TWMJF) (TSX: WEED) and Aurora Cannabis, Inc. (OTC: ACBFF) (TSX: ACB) are major suppliers of high-quality, medical-grade marijuana, which is critical for many biotech companies who need a source of plant-based starting materials.

The issue is that plant-based processes (planting, growing, harvesting, extracting and purifying) result in active ingredients at varying concentration levels with inconsistent qualities, including impurities such as pesticides. Companies interested in this approach for their products need to establish vast and high-volume marijuana greenhouse growing operations. This is a huge expense, further compounded by the complex process to produce pharmaceutical grade cannabinoids that meet the GMP requirements for FDA approval. InMed Pharmaceuticals (CSE: IN) (OTCQB: IMLFF) has taken the inside track in the industry and has just completed the world's first-ever recorded study that successfully stitched together several key components in the drug development continuum for cannabinoid therapies, including:

• biosynthesizing a cannabinoid;
• packaging the cannabinoid as a nanoparticle;
• formulating the nanoparticles into a novel tissue-specific delivery vehicle;
• and confirming delivery and diffusion into the target tissue.

This study is significant in validating InMed's wide spectrum of cannabinoid know-how for pharmaceutical development, which ranges from discovery and manufacturing to formulation and delivery. Whereas other companies are in the process of researching or testing only the two main cannabinoids found in marijuana (THC and CBD), InMed is using its proprietary bioinformatics and manufacturing process to research the physiological impact of all 90+ cannabinoids found in the plant. The company's biosynthesis process results in pharmaceutical grade (>95%) purity and is bioidentical to the plant's cannabinoids. Importantly, by making individual cannabinoid compounds, InMed can avoid any contamination by tetrahydrocannabinol (THC) - the mind-altering chemical in the cannabis plant - and, therefore, InMed products will have no psychoactive properties.

Building on this capability, InMed has also achieved an industry first with its development of a cannabinoid nanoparticle hydrogel as the delivery mechanism for its INM-085 candidate, which is formulated to treat glaucoma by reducing elevated intra-ocular pressure and providing protection to the retinal nerves. Glaucoma treatment is usually administered via eyedrops, which are typically washed away immediately due to blinking. As a result, patient compliance with their drug administration schedules is poor in this disease. A hydrogel delivery mechanism, however, has a huge advantage in that it forms a medicated gel-like lens over the eye. INM-085 is intended as a once-per-day eyedrop administered immediately prior to the patient's bedtime, intending to assist in reducing the high rate of non-compliance and to maximize drug absorption from a single drop.

Following this success, InMed is scaling its manufacturing process and pursuing research into other medical conditions by leveraging its know-how in cannabinoid drug development. Because biosynthesized cannabinoids are identical to those found in nature, they have potentially fewer adverse events associated with varying drug structures and may confer better efficacy. Biosynthesis also avoids several of the drawbacks associated with growing marijuana, including elimination of pesticides that can be toxic to people and harmful to the environment.

As favorable evidence of cannabis for therapeutic applications expands, the medicinal marijuana market continues to swell with innovation. Much focus is placed on biotechs, such as InMed, that are actively engaged in the development of cannabinoids for various therapeutic applications. Notably, InMed has a significant advantage in its ability to create biosynthetic cannabinoids in a controlled laboratory setting. The company's breakthrough approach to cannabinoid biosynthesis has incredible potential in helping other companies with their cannabis-related drug development efforts.

Another company deeply invested in the manufacturing of synthetic (chemistry-based) cannabinoids is Zynerba Pharmaceuticals (NASDAQ: ZYNE). The clinical-stage pharmaceutical company is focused on developing proprietary synthetic cannabinoid treatments designed for transdermal delivery and targeting patients with unmet medical needs. Zynerba is currently working on two products: a synthetic CBD gel for patients with osteoarthritis, epilepsy and Fragile X syndrome, and a synthetic THC transdermal patch targeting fibromyalgia and peripheral neuropathic pain. With a market cap of $128 million (as of October 20, 2017) and a recent stock price surge following the announcement of positive results from a clinical study into the effects of its transdermal CBD gel on pediatric and adolescent patients with Fragile X syndrome, Zynerba looks set to become a leading synthetic CBD manufacturer and a highly attractive investment opportunity on the fast-growing cannabinoid-based pharmaceutical market.

Cannabinoid synthesis or biosynthesis can have a highly positive impact on companies such as GW Pharmaceuticals (NASDAQ: GWPH), which has developed commercial-stage cannabinoid products for both orphan and non-orphan indications in neurological conditions. The company also created a CBD product for the treatment of certain epilepsy syndromes and developed the world's first cannabis-based prescription medicine for the treatment of spasticity in sufferers of multiple sclerosis. While it is a leading cannabis biotech in terms of market cap ($2.7 billion as of October 23, 2017), without the ability to create biosynthetic cannabinoids in-house, GW Pharmaceuticals outsources the cultivation of cannabis for its products to UK-based British Sugar. Though British Sugar's crop yield is expected to support the development of GW Pharmaceutical's childhood epilepsy drug, the cultivation comes at considerable expense due to electricity, lighting, heating, real estate, manpower and other resources.  

Other biotech companies turn to the green fields in Canada, where roughly 38 licensed cannabis producers are scrambling to keep up with the demand for legalized medicinal marijuana and impending demand for recreational marijuana (expected to be legalized July 2018).

Currently Canada's largest producer of marijuana, Canopy Growth Corp. (OTC: TWMJF) (TSX: WEED.TO) has over half a million square feet of greenhouse cannabis capacity and has committed to developing 1.3 million square feet of greenhouse growing capacity in British Columbia. The company is partnered with Bedrocan BV, a company based in Holland, to produce and distribute medical-grade cannabis via one of its core brands, Bedrocan Canada, demonstrating the need for high quantities of medicinal-grade cannabis. Due to its consistently high quality, Canopy Growth's products are used extensively in clinical research in several European countries. In addition, the company recently launched the EQUAL Study to evaluate the effects of medical cannabis use on quality of life. Notably, this is one of the largest marijuana studies in the world.

In August, Canopy Growth reported first quarter fiscal 2018 revenue of C$15.8 million, marking a year-over-year increase of 127.4 percent and an increase of 8 percent compared to the fourth quarter of fiscal 2017 revenues.

"Our focus in the first half of calendar 2017 has been preparing our business to lead the legal recreational market that is set to open in Canada in 2018, while continuing to be the clear leader in the ongoing medical market," Canopy Growth chairman and CEO Bruce Linton stated in the earnings release.  

Another cultivator benefitting from most biotech companies' need for cannabis products is Canada-based Aurora Cannabis (OTCQX: ACBFF) (TSX: ACB.TO), a leading producer and distributor of medical cannabis. The company also operates a portal for registered physicians and patients that make it easier to prescribe and fill prescriptions. Aurora recorded fourth-quarter 2017 revenues of $5.9 million, citing growth in patient numbers and an increase in the average price per gram of product sold, which now includes high-margin cannabis oils. Also in the fourth quarter, Aurora acquired Peloton Pharmaceuticals, including a 40,000-square-foot facility that, upon completion, is expected to generate its first harvest shortly after calendar-year end.

With the successful development of its biosynthetic cannabinoid for the treatment of glaucoma, InMed continues to make strides down the pathway toward making biosynthesized cannabinoid pharmaceutical products a reality. The company opened the door to further developments in the application of cannabinoids for many other therapies.

For more information on InMed Pharmaceuticals, please visit: InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)  

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