This little-known company may give Epidiolex a run for its money

When a groundbreaking anti-epileptic drug, Epidiolex was launched in late 2018, it was a historic event.  Epidiolex was the first cannabis drug ever to be approved by the FDA.

What’s more, Wall Street analysts predicted it would be a “blockbuster.”

Blockbusters are drugs that generate sales of $1 billion or more per year.  Fewer than 1% of the 20,000+ drugs on the market today have achieved blockbuster status.[1]

They are the holy grail for both pharmaceutical companies and investors, and they can make the fortunes of both.

On its release, JPMorgan forecasted that Epidiolex sales would reach $1 billion by 2023.[2]  BofA went on to predict annual sales would hit $2.5 billion by 2027.[3]

That small biotech with less than $10 million in annual revenue would have the next blockbuster drug – and the drug would be a simple concoction of cannabidiol (CBD), one of the two main active constituents of cannabis – caught the attention of investors across the globe.

The blockbuster forecast was especially surprising since Epidiolex may suffer the same problem that plagues nearly every developer of orally consumed CBD products – poor bioavailability.

Solving CBD’s big bioavailability problem

Bioavailability refers to the amount of an active substance that is absorbed into the system to reach its therapeutic target.  When the active compounds of cannabis, either CBD or THC, are taken orally, only about 15% of those metabolites are absorbed into the bloodstream.[4]

The majority are passed out of the body as waste, meaning that the vast part of every dose never reaches its therapeutic target.  That may even be the case with FDA-approved Epidiolex, which is taken as a liquid that is administered orally via syringe.

With the global cannabis-based pharmaceuticals market expected to reach $50 billion by 2029, bioavailability is a problem in need of an immediate remedy.[5]  And one little-known drug developer may have the solution.

Advanced technology to improve bioavailability

We’ve located a little-known developer of advanced drug delivery technologies, with a focus on off-patent drugs and cannabis-based products.

It’s a unique business model that allows the company to rapidly bring essential drugs onto the market is significantly more efficient dosage forms without the burdensome time and expense of full clinical trials.[6] The FDA currently lists more than 300 off-patent drugs for which there is no approved generic version.[7]

The company has also developed and patented several novel drug delivery technologies, including sublingual (under the tongue) and transdermal (on the skin) thin films.  Thin films are emerging as the future of drug delivery because of their many advantages, including superior bioavailability and ease of administration.

Analysis from Market Data Forecast reports that the global thin-film market will grow at 9% CAGR to reach $29.2 billion by 2025, an increase of more than $10 billion over today.[1]  The report states that “the growing demand for efficient drug delivery systems has amplified the uptake of thin-film drugs due to their efficiency and effectiveness.”

10 to 20 times more CBD bioavailability

With the massive expected growth of the pharmaceutical cannabis market and the sad state of current cannabis bioavailability, one company that’s currently trading for under $3, saw a timely opportunity.

To that end, they have developed a sublingual thin film cannabinoid dosage form that the company reports “may yield as much as a 10- to 20-fold increase in bioavailability of CBD over existing oil delivery methods.”[2]

A therapeutic CBD product with that magnitude of efficiency is well beyond even what other sublingual thin-film technologies have been able to achieve.

Placed under the tongue, these thin films allow its CBD formulation to enter the circulatory system directly by absorption through the mucus membranes.  This means they bypass the harsh conditions of the stomach and deliver a significantly larger proportion of active compound per dose than swallowed CBD, whether it’s in pill, liquid, or edible form.

The International Journal of Pharmacy and Pharmaceutical Sciences says, “Absorption of the drug through the sublingual route is 3 to 10 times greater than oral route and is only surpassed by hypodermic injection.”[1]

In other words…

This company may give Epidiolex a run for its money

Like Epidiolex, their developmental solution is targeted for refractory epilepsy, defined as hard-to-treat forms of the disease.  Specifically, both target Dravet syndrome and Lennox-Gastaut syndrome.  About a third of all those who suffer with epilepsy do not respond to treatment.[2]Which is why the refractory epilepsy market is expected to reach $2.94 billion by 2023.[3]

That’s also why Wall Street expects Epidiolex to be a billion-dollar blockbuster, being a far more effective treatment than any others currently on the market.  But Epidiolex is not a highly secret, proprietary formula. As the company admits, the active ingredient is “nearly 100% cannabidiol.”[4]

Though the bioavailability of Epidiolex isn’t published, orally swallowed cannabidiol (CBD) is on average about 6.5 times less bioavailable than sublingual delivery.[5]

What’s more, Epidiolex may suffer from another drawback. The drug is administered as a liquid taken via oral syringe, making it prone to dosing errors.  One randomized, controlled study published in the journal Pediatrics asked 2,110 parents to administer a liquid compound to their children via syringe.  The results of the study showed that fully 24% of the parents made dosing errors.

Later, the Journal of the American Medical Association sounded the alarm on the frequency of unintentional drug overdoses among children given oral liquid medications.[6]

Thin films are also easier to administer, especially for people who have trouble swallowing, which is estimated to be around 37% of the population.[7]  In fact, a review in the journal Current Drug Delivery says, “Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosage forms.”

Which is why, the review notes, “Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films.”[8]

Top 6 reasons to get information this undervalued company right now

  1. They’re solving CBD’s bioavailability problem with a unique, proprietary sublingual thin-film technologythat may yield as much as a 10- to 20-fold increase in CBD absorption. The product is in final formula testing before proceeding to commercialization trials. With the global cannabis-based pharmaceuticals market expected to reach $50 billion by 2029, there is an enormous opportunity for their thin-film platform.
  2. They’re epilepsy drug in the final stages of developmentand appears very similar to FDA-approved Epidiolex, but with a potential 10 times more bioavailability than Epidiolex because of the company’s thin-film delivery technology. The market for refractory epilepsy treatment is expected to reach $2.94 by 2023.
  3. Their business model includes applying its thin-film platform to off-patent drugspreviously approved by the FDA, thus creating better, more bioavailable versions while bypassing costly clinical trials before commercialization.
  4. They appear close to locking down an exclusive partnership with Germany’s second largest brewer, for development and commercialization of cannabis-based beveragesthroughout the European region and beyond. The global cannabis beverages market is expected to reach $2.8 billion by 2025.
  5. They’re  an attractive buyout target in an exploding industry that is being eyed hungrily by food, tobacco, and pharmaceutical companies.
  6. With a thin film technology that delivers vastly higher bioavailability, their epilepsy and infection disease products already in the final stages of development and their access to the German and European markets, this company is sure to gain the interest of major players both inside and outside the cannabis industry.

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