Innovation Drives Value for Leading Cannabis Biotechs

Wednesday, November 15, 2017 Drug News
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NEW YORK, November 15, 2017 /PRNewswire/ --

The medicinal cannabis

market is expected to reach almost US$56 billion by 2025, according to a report by Grand View Research (http://nnw.fm/rXx0Z), driven in part by demand for therapeutic applications of cannabinoid-based drugs for pain
relief, suppression of nausea and appetite stimulation, as well as for symptomatic treatment of diseases such as glaucoma, cancer and multiple sclerosis. As an increasing volume of scientific research leans toward the efficacy of cannabis-based drugs, innovative biotech companies are advancing their R&D to develop therapeutic candidates that envelop the potential health benefits of the marijuana plant. One such company is InMed Pharmaceuticals, Inc. (CSE: IN) (OTC: IMLFF) (IMLFF Profile), which has several cannabinoid-based drug candidates in its pipeline. The company has also developed a proprietary and groundbreaking technology for the biosynthesis of all 90+ cannabinoids via an innovative process that enables a wide spectrum of drug development activities in-house, from drug manufacture to novel, tissue-specific formulation and all clinical and regulatory work. Though currently valued at only US$81 million, InMed's capabilities position it among the ranks of larger biotechs with important innovations in this industry, including GW Pharmaceuticals plc (NASDAQ: GWPH), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Cara Therapeutics, Inc. (NASDAQ: CARA) and INSYS Therapeutics, Inc. (NASDAQ: INSY).

Extracting cannabinoids for medicinal applications using an agriculture-based model involves a lengthy, expensive and labor-intensive process of planting, growing, harvesting, extracting and purifying. To avoid the shortcomings of an agricultural approach, several biotechs have turned to chemical processes to produce synthetic cannabinoids that can deliver consistent quality, thereby overcoming some of these concerns and increasing their prospects of gaining FDA approval. However, synthetic production can be expensive and can present potential safety issues. It is difficult to synthesize compounds that are identical to their natural counterparts, and the slightest structural variations can affect the quality and safety of the finished product.

While other biotech companies instead favor partnerships with pharmaceutical raw material suppliers for their cannabinoid supply, InMed Pharmaceuticals (OTCQB: IMLFF) (CSE: IN) utilizes its proprietary biosynthesis process to manufacture any of the 90+ individual cannabinoids found in cannabis. The company's computer-based platform bolsters this production capability by using bioinformatic algorithms to match individual cannabinoids to specific diseases, thereby identifying potential therapeutic targets for its drug development programs.

InMed has been utilizing this bioinformatics approach for several years now. The platform enables the company to assess the interaction of individual cannabinoids with genes, target receptors, proteins and other criteria to measure suitability as active ingredients to target diseases. The output from the bioinformatics analysis can then be rapidly and cost-effectively validated in tissue and disease-specific in vitro and in vivo experimentation. Once confirmed in these bench-top experiments, the individual cannabinoids can then be manufactured at large scale using InMed's proprietary biosynthesis system.

In short, InMed has the ability to:

1. Identify which cannabinoids have potential to treat specific diseases

2. Manufacture the desired pharmaceutical-grade cannabinoid at >95% purity, with identical structures to cannabinoids found in nature, with no pesticide residue; and

3. Formulate the cannabinoid drug candidate into a tissue-specific pharmaceutical product for advanced preclinical and clinical testing.

This innovation covers a broad spectrum of the drug development process without the need to create synthetic cannabinoids or rely on the quantity and quality of other cannabis growers.

InMed currently has two advanced candidates in its development pipeline. INM-750 is being developed for the treatment of epidermolysis bullosa (EB) and includes multiple cannabinoids as active ingredients. EB is a rare genetic disease with a very high unmet medical need and no currently approved treatments. INM-750 is being developed for topical application to regulate disease activity and alleviate the symptoms of EB. INM-085 is being development as a therapy for glaucoma, to be delivered as a hydrogel which can be administered once a day directly to intraocular pressure (http://nnw.fm/2EIBu). The estimated combined market potential of these two candidates is $6 billion per year.

InMed's innovative approach to bioinformatics and biosynthesis is groundbreaking, and the company has already filed a provisional patent to protect its cannabinoid biosynthetic process.

InMed is currently working on scaling up its manufacturing capability, pivoting from the success of its proprietary laboratory-based systems. To assist with its advancing position in the market, InMed engaged as a consultant Ben Paterson, P.E., a professional engineer with extensive experience in the development of purification and manufacturing processes in the pharmaceutical industry (http://nnw.fm/9Bzoh).

Having pioneered the manufacture of cannabinoids, InMed is well positioned to maximize partnership activities by assisting biotechs and other companies - such as GW Pharmaceuticals (NASDAQ: GWPH) - with their cannabis-based drug programs. GW Pharmaceuticals is a world leader in the research and development of plant-based cannabinoid therapeutics, with a primary focus on the treatment of neurological conditions. Valued at more than US$2.5 billion, the company commercialized the world's first cannabinoid-based drug for the treatment of spasticity caused by multiple sclerosis. Its leading development candidate is a formulation for the treatment of childhood-onset epilepsy disorders like Lennox-Gastaut syndrome and Dravet syndrome. On October 30, GW announced that it had completed its rolling submission of a new drug application to the Food and Drug Administration (FDA). The company also has several other product candidates in development for treating glioma and schizophrenia.

Zynerba Pharmaceuticals (NASDAQ: ZYNE) focuses its research efforts into developing synthetic cannabinoid therapeutics using a transdermal delivery mechanism. It has two products in development: ZYN001 - a THC-based formulation for pain relief in patients with fibromyalgia and peripheral neuropathic indications, and ZYN002 - an innovative and patented gel, which contains the non-psychoactive cannabidiol (CBD) as an active ingredient, for transdermal delivery to patients with osteoarthritis and Fragile X syndrome. Zynerba's market valuation is over US$172 million.

Connecticut-based Cara Therapeutics (NASDAQ: CARA) has a market cap of US$400 million. The company has five product candidates in development, including a cannabinoid-based product, focusing on acute and chronic pain relief and the treatment of pruritus. Its proprietary formulations target the body's peripheral nervous system. Medications that are available to treat these conditions typically have undesirable side effects, and initial trials of some of these candidates have demonstrated efficacy for both conditions without adverse reactions. The company's most advanced opioid drug candidate, CR845, has been tested in phase 2 trials on patients undergoing laparoscopic hysterectomy or bunionectomy procedures with good results in pain reduction and the reduction of opioid-related side effects.

The improvement of patient care by delivering cannabinoid-based therapies for unmet patient needs is the mission of INSYS Therapeutics' (NASDAQ: INSY), which is valued at US$380 million. The company markets a fentanyl sublingual spray, called Subsys®, for the relief of pain associated with cancer. Since 2014, Subsys® has achieved a market share of 48 percent of prescription fentanyl products. INSYS is also developing Syndros®, a synthetic THC product for the second-line treatment of nausea induced by chemotherapy and AIDS-related weight loss.

The rapidly emerging cannabis-based drug market is set for significant growth over the next few years as regulatory restrictions are eased and more companies are licensed. The innovation shown by these companies to date is what is needed to leverage market demand.

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

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