Biosynthesis: Making the Impossible Possible in Medicinal Cannabis

NEW YORK, November 14, 2017 /PRNewswire/ --

The U.S. pharmaceutical industry is pocked with pitfalls that make it difficult for the development of cannabis-based drugs. To receive FDA approval, drug manufacturers must produce a consistent, pharmaceutical-grade product. Drug researchers with cannabis-based candidates are largely dependent on cannabis producers to access their drug raw materials. And therein lies the issue. The cannabis production sector has had its share of product recalls, and is saddled with pricey cost of commercial cultivation. The roadblocks are considerable - from legal and execution standpoints - making these efforts not quite impossible but certainly, currently, difficult. Canada-based biopharmaceutical company InMed Pharmaceuticals, Inc. (CSE: IN) (OTC: IMLFF) (IMLFF Profile) is taking these challenges head-on, and has broken new ground with an innovative, proprietary biosynthesis process that reliably creates pure cannabinoids. This process is capable of making any of the 90+ individual cannabinoids, under strict quality control resulting in >95% purity with no pesticides, and in a consistent fashion - factors that current plant growing methods of production cannot accomplish. Biosynthesized product with consistently high purity and quality poses a considerable advantage over the medical marijuana used by companies like CanniMed Therapeutics, Inc. (TSX: CMED) (OTC: CMMDF) (FRA: 0GB), which cultivates its own cannabis for its product pipeline. Any biotech company seeking to develop cannabinoid-based drugs could benefit from InMed's unique approach. Currently, these biotech companies are dependent on growers like Aurora Cannabis, Inc. (TSX: ACB) (OTC: ACBFF), Canopy Growth Corp. (TSX: WEED) (OTC: TWMJF) and Aphria, Inc. (TSX: APH) (OTC: APHQF) to supply the raw flower or specific cannabinoid extracts needed, albeit only a few cannabinoids can be economically extracted from the plant. Such extracted product may not have the purity or consistency required to qualify as an FDA-approved pharmaceutical ingredient.

The extraction techniques from plant-growing operations are subject to high fluctuation in drug concentration, as flowers from the same marijuana plant display high fluctuations in drug composition. A key factor in receiving formal drug approval from regulatory authorities includes product consistency, which may be one reason the FDA, to date, has never approved a botanically-derived marijuana drug. A few synthetic cannabinoid-based drugs have, however, been approved by the FDA (http://nnw.fm/dyD4o), and experts believe marijuana's only future as a medicine in the U.S. is through its isolated, pure cannabinoid components and their synthetic counterparts.

While manufacturing synthetic cannabinoids is a potential means of sidestepping the various prohibitive aspects of agricultural cannabis production, many development efforts in this area have failed. Various companies have attempted to chemically synthesize cannabinoid compounds for pharmaceutical application, but the primary restrictive factor is the difficulty of duplicating these compounds in a way that makes them identical to the naturally-occurring ones. Even a slight variation in structure can mar the efficacy and safety of synthetic cannabinoid compounds, and, as with natural sourcing, the time drain, expense and tedium of the synthetic manufacturing process (along with the large quantities of chemical waste it creates) make it a problematic enterprise.

InMed Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF) breakthrough biosynthesis process allows it to control the entire drug development process, in house - and without the inherent challenges of traditional agricultural cultivation methods.

Biosynthesis, or the process of producing complex molecules within living organisms or cells, is currently employed in various industrial applications, including using bacteria or yeast-based systems to produce pharmaceuticals. InMed's proprietary, pioneering approach to cannabinoid biosynthesis is truly a drug development game changer that has the potential to overcome FDA regulatory hurdles and bypass the other shortcomings associated with botanical cannabis cultivation. This process could open up several possibilities in terms of improving consistency and enabling biotechs to harness the potential of all cannabinoids.

InMed employs an E. coli-based expression system for manufacturing cannabinoids that has proven internally to be much more efficient and robust than other microbial platforms, and this system enables the high-yield manufacturing of all 90+ naturally occurring cannabinoids, combining the intrinsic safety and known effectiveness of natural drug structures with the control, quality and convenience of lab-based manufacturing.

Employing this exclusive process in a controlled lab setting, scientists at InMed are able to create cannabinoid compounds that are identical to those that occur naturally while eliminating problems associated with inconsistency and contamination from pesticides.

Aside from inconsistency issues, another stumbling block on the botanical marijuana side is the difficulty of extracting compounds from the cannabis plant in adequate amounts and purities to pharmaceutically test them. Natural sourcing of most cannabinoid compounds is very time-consuming, difficult, expensive, inconsistent (as previously mentioned) and low-yielding. The natural sourcing process only yields about two or three cannabinoids that can be derived in adequate quantities for research, while the rest of the cannabinoid compounds only manifest themselves in trace amounts that are not accessible through extraction from plants.

InMed's biosynthesis method is can reduce the costs and time required to manufacture cannabinoid compounds that are pharmaceutically active. It is also capable of manufacturing not just some but all naturally occurring cannabinoids.

InMed is effectively bringing cannabis-based drug development into a new era, shaking up the established, agriculture-based mentality of "plant, grow, harvest, extract and purify" that has long been the norm in the area of manufacturing raw cannabinoid material.

The benefits of InMed's novel approach are several and include:

• Substantial cost savings in comparison to traditional agricultural methods
• Easier path to scale-up and systems optimization
• Superior production, purification, quality control as compared to agricultural approaches and better structural integrity in comparison with other chemical manufacturing practices

Ability to access minor cannabinoids for which plant-based extraction methods are currently economically unfeasible

InMed recently announced a provisional patent application filing for this proprietary cannabinoid manufacturing biosynthesis program-the first of many to come (http://nnw.fm/Z30dH). Once this inaugural patent application is converted into an international Patent Cooperation Treaty (PCT) application and is pursued on a global scale in important jurisdictions, InMed will have significant commercial protection for its biosynthesis program. The company plans to actively convert this initial patent filling and subsequent provisional patents into national-stage filings in all major commercial jurisdictions.

In terms of InMed's internal drug development abilities, a recent press release from the company (http://nnw.fm/EZ0Gk) validates its capability to conduct a broad array of drug development activities that are crucial to obtaining eventual FDA approval for cannabinoid-based drugs. As discussed in the press release, InMed has successfully and consistently biosynthesized a pharmaceutical-grade cannabinoid using its novel E. coli-based system; packaged the cannabinoid as a nanoparticle; formulated a cannabinoid drug candidate into a novel, tissue-specific delivery vehicle; and confirmed drug delivery and diffusion into a target tissue.

The press release announced the results of a study co-sponsored by InMed and the University of British Columbia, which is, to the company's knowledge, the very first study to ever report hydrogel-mediated cannabinoid nanoparticle delivery to the eye. This resulted in bolstered drug uptake through the cornea and lens. Ordinary ocular formulations, like eyedrops, are almost instantly washed away following administration because of blinking. In the study, however, InMed's proprietary hydrogel delivery method demonstrated distinctive rheological characteristics that enabled it to form a thin, uniform coating over the cornea through blinking. The gel-like "lens" that was created over the cornea held the drug in place, allowing trans-corneal absorption of the drug to occur. The drug was then able to diffuse within the eye. The overall drug delivery achieved through this hydrogel nanoparticle formulation was three times higher than the control formulation.

"Importantly, this study offers further validation of InMed's capabilities in moving the science of cannabinoid pharmaceuticals forward," InMed President and CEO Eric A. Adams said in the press release. "Results like this, combined with our expanding patent portfolio and list of publications, on-going R&D, and renowned scientific team and collaborators demonstrates our depth of know-how and supports our trajectory to becoming an industry leader."

InMed's drug pipeline - developed using its biosynthesis process - currently includes two products: INM-085 for the treatment of glaucoma and INM-750 for the treatment of epidermolysis bullosa. This pipeline is founded on the company's ability to produce its own pharmaceutical-grade cannabinoids for use in its products, which enables InMed to manage the entire drug development cycle. Using bioinformatics-a proprietary, computer-based drug/disease targeting platform developed by InMed-the company is also able to identify novel cannabinoids that could be utilized in targeting specific diseases. InMed can then biosynthesize those cannabinoids for product development.

This groundbreaking work is not only helping InMed toward overcoming drug approval barriers but could also have a huge impact on the efforts of other drug development companies within the cannabis sector that are striving to create cannabinoid-based therapies to treat various medical conditions.

InMed's ability to consistently manufacture pharmaceutical-grade cannabinoids demonstrates the company's favorable cost-savings and quality aspects compared with traditional cannabis producers. While such producers are working to meet the demands of biotech companies, which are, in turn, striving to satisfy regulatory standards, these producers may face many challenges.

One of the biggest marijuana growers in the world is Canopy Growth Corp. (TSX: WEED.TO) (OTC: TWMJF), which operates more than half-a-million square feet of production space. Despite its size and market domination, Canopy is dependent on significant capital and large parcels of land and is also handicapped by huge operating costs and the typical quality control issues seen with agricultural operations.

Another large producer, Aurora Cannabis (TSX: ACB.TO) (OTCQX: ACBFF) operates a 55,200-square-foot cultivation and harvesting facility in the Rocky Mountains, and the company is in the process of adding an additional 840,000 square feet across two other sites in Canada. Aurora owns a 19.9% stake in the first Australian company licensed to cultivate and conduct research on medical cannabis, and it owns a leading Germany-based wholesale importer, exporter and distributor of medical cannabis. In January 2017, Aurora announced a Type II recall of its products, as some of its marketed offerings contained "residual levels of myclobutanil and/or bifenazate that exceed any of the levels permitted in food production for these two pesticides."

Aphria (TSX: APH.TO) (OTCQB: APHQF), a producer of medical-grade cannabis as well as capsules, vaporizers and orally-administered cannabis oil droppers, initiated a Type III recall of its own in March 2017 due to mislabeling of the delta-9-tetrahydrocannabidiol (THC) content of some of its products.

The obstacles faced by cannabis cultivators and the subsequent disadvantages to the drug development companies that rely on them attest to the importance of the revolutionary biosynthesis process InMed has pioneered. Despite continued federal restrictions on cannabis research and cultivation in the U.S., InMed's innovations have the potential to help biotechs clear the hurdles and create biosynthesized cannabinoid-based pharmaceutical products of unparalleled consistency and quality required to meet the FDA's standards. Additionally, the ability to manufacture every type of cannabinoid, which is made possible by InMed's process, is poised to be one of the most exciting innovations the medical cannabis sector has seen.

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

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