FDA Cannabinoid Approvals Causing Big Biotech Gains

As acceptance of cannabinoids for medicinal use grows, somewhat recent U.S. Food & Drug Administration (FDA) approvals of synthetic delta-9-tetrahydrocannabinol (THC), are giving cannabinoid-based pharmaceutical companies a head start over the rest of the medicinal cannabis sector.

However, it’s impossible to ignore the effect that the recent announcement by US Attorney General Jeff Sessions will have on the sector outside of the DEA-approved pharmaceutical companies in the cannabis space.

The current benefactors are the drug developers and patients experiencing a wave of positives in the advent of a cannabinoid-based pharmaceutical revolution.

Companies benefitting as of late include Vitality Biopharma, Inc. (OTCQB: VBIO), GW Pharmaceuticals plc (NASDAQ: GWPH), and INSYS Therapeutics, Inc. (NASDAQ: INSY).

Ultimately, the global medical cannabis sector is on pace to reach US$50 billion in revenues by 2025.

Unlike the major cannabis growers, it’s the biotech firms with DEA approval working with cannabinoids that will have further reach for patients in the more immediate future.

Many developers of cannabinoid-based medications have experienced gains and breakthroughs that will be more likely to be approved and prescribed in the near term, including drug formulations that utilize cannabis botanical extracts.

These companies include Vitality Biopharma, Inc. (OTCQB: VBIO), GW Pharmaceuticals plc (NASDAQ: GWPH), and INSYS Therapeutics, Inc. (NASDAQ: INSY).

FDA’S ROLE IN CANNABINOID ACCEPTANCE

So far, the FDA has not approved organic cannabis plant matter—However, it did take another significant step in 2016, through the approval of synthetic THC in a liquid form.

Synthetic THC, known as dronabinol, is the active ingredient in Marinol owned by Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) , and liquefied form in Syndros owned by INSYS Therapeutics, Inc. (NASDAQ: INSY).

One of the next FDA approvals is expected to be Sativex (naxibimol), which is an oromucosal spray of a formulated extract of THC and CBD, from GW Pharmaceuticals plc (NASDAQ: GWPH).

However, innovations in drug delivery systems has given way for major gains in the sector from companies not necessarily as large as GW and its $3.723 billion market cap.

Over the last 30 days, INSYS Therapeutics, Inc. (NASDAQ: INSY) has seen its share price rise nearly 220%, with double-digit gains in the opening two trading days of 2018.

This time, it was through another FDA announcement, where the regulatory body granted INSYS’s cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome a “Fast Track” designation.

Also set to capitalize on novel methods of drug delivery, and proprietary changes to already approved compounds is Vitality Biopharma, Inc. (OTC: VBIO), through an entirely new class of cannabinoid prodrugs, known as cannabosides.

THE RISE OF VITALITY’S CANNABOSIDES

While Vitality Biopharma is still an early-stage drug developer, it already has DEA approval, and has developed a novel class of cannabinoid pharmaceuticals. Vitality’s breakthrough releases cannabinoids in a targeted fashion within the GI tract, and do so in a way that eliminates all drug psychoactivity or intoxication.

Known as “cannabosides”, Vitality’s breakthrough class of cannabinoid pharmaceuticals are produced using a novel biosynthesis approach that the company originally developed to improve the taste of the low-calorie natural sweetener stevia.

Knowing that THC (as dronabinol) has been previously reviewed and approved by the FDA, and has been established as safe and effective for use with appetite stimulation and for treatment of nausea and vomiting, Vitality set about innovating that use further.

Through the targeted release and then restriction of the active THC compound in the GI tract, cannabosides are designed to enable oral delivery of large concentrations of cannabinoids that provide therapeutic benefits, all while reducing or even eliminating drug psychoactivity.

The company recently announced the introduction of VITA-100, Vitality’s lead cannabinoid drug formulation that’s a non-psychoactive THC prodrug.

Vitality will focus its initial clinical development efforts on the proprietary THC cannabinoid drug formulation, with immediate plans to complete a first-in-man clinical study in the first half of 2018.

Their plans are to evaluate VITA-100 in Phase 2 trials to treat inflammatory bowel disease(IBD), irritable bowel syndrome, and narcotic bowel syndrome, a severe form of opiate-induced abdominal pain.

To date, THC has shown to be very effective in treating drug-resistant Crohn’s disease, with symptomatic relief reported by the vast majority of IBD patients tested—more than 75%.

By targeting the more than 1.4 million Americans diagnosed with IBD (which includes Crohn’s disease and ulcerative colitis), Vitality is aiming to bring relief to patients while removing any stigma or fear due to possible intoxication from THC treatment.

Restricting THC to the GI tract gives VITA-100 an advantage, through negating unwanted intoxication that would otherwise occur if the compound were delivered into the bloodstream and brain.

With the announcement of VITA-100, Vitality Biopharma signals it will look towards joining the much larger cannabinoid-based pharmaceutical developers that have already blazed the path.

POTENTIAL COMPARABLES

GW Pharmaceuticals plc (NASDAQ: GWPH)

GW is a biopharmaceutical company, engaging in discovering, developing, and commercializing cannabinoid prescription medicines derived from the Cannabis plant. GW markets Sativex, for the treatment of spasticity due to multiple sclerosis, which is also in Phase II trials for neuropathic pain. Their product pipeline includes Epidiolex, which is in Phase III clinical development to treat Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms. GW Pharmaceuticals plc was founded in 1998 and is based in the UK.

INSYS Therapeutics, Inc. (NASDAQ: INSY)

Insys is a specialty pharmaceutical company, developing and commercializing supportive care products. Insys markets SUBSYS, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the US. Their lead product candidate is SYNDROS, an orally administered liquid formulation of dronabinol for treating CINV and anorexia associated with weight loss in patients with AIDS. Insys is also developing Cannabidiol Oral Solution, a synthetic cannabidiol for childhood catastrophic epilepsy syndromes. Insys is headquartered in Arizona.

For a more in-depth on Vitality Biopharma, look into the company’s website, where you can view an in-depth investor’s presentation.

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