PROFILES
This Could Be Like Buying GW Pharma In 2013
XPhyto Therapeutics’ (CSE: XPHY, OTCQX: XPHYF) game-changing drug candidate could give Epidiolex a run for its money in the $16.5 Billion epilepsy treatment market.
When GW Pharmaceuticals launched its groundbreaking anti-epileptic drug Epidiolex 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.[1]
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.[2] And one little-known drug developer XPhyto Therapeutics may have the solution.
XPhyto Therapeutics (CSE: XPHY, OTCQX: XPHYF): Advanced technology to improve bioavailability
XPhyto is a 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 market is significantly more efficient dosage forms without the burdensome time and expense of full clinical trials. The FDA currently lists more than 300 off-patent drugs for which there is no approved generic version.
XPhyto has several promising pharmaceutical and cannabis solutions in its development pipeline, including chronic pain, infectious disease detection, appetite regulation, inflammatory dermatology, and sleep disorders.
The company has 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. 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.”
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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, XPhyto 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.”
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, XPhyto’s 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.”
XPhyto’s development pipeline includes several cannabis-derived formulations, but the one receiving the most attention is an oral thin film CBD-based sublingual epilepsy product.
In other words…
XPhyto Therapeutics (CSE: XPHY, OTCQX: XPHYF) may give Epidiolex a run for its money
XPhyto’s proprietary thin-film technology may provide a distinct and instant advantage over GW Pharmaceuticals’ Epidiolex.
Like Epidiolex, XPhyto’s 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 from epilepsy do not respond to treatment. Which is why the refractory epilepsy market is expected to reach $2.94 billion by 2023.
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.”
Though GW Pharmaceuticals does not publish the bioavailability of Epidiolex, orally swallowed cannabidiol (CBD) is on average about 6.5 times less bioavailable than sublingual delivery.
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.
Thin films like XPhyto’s are also easier to administer, especially for people who have trouble swallowing, which is estimated to be around 37% of the population. 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
XPhyto’s thin-film epilepsy solution rapidly advancing to clinical studies
XPhyto is currently in the final stages of product development and testing.
Over the first three months of 2020, XPhyto completed the initial stage of product development through the company’s wholly-owned subsidiary, Germany-based Vektor Pharma TF GmbH.
Vektor is a well-established narcotics research and development firm founded in 2009. As a recognized leader in thin-film drug delivery technologies, including for Fentanyl, Buprenorphine, Hydromorphone, Oxycodone, and cannabis, they hold a number of patents as well as licenses for import, handling, and manufacture of narcotics and vaccines.
In a March 2020 news release, the company stated that “based on recent positive product development results, XPhyto will be advancing the [epilepsy] program to clinical studies immediately.”[1]
XPhyto CEO Hugh Rogers says, “An efficient and well-defined dosage form is the future of cannabis-based medicine. High bioavailability with controlled and reproducible delivery is critical. Our initial results suggest significant potential timing and efficiency advantages over conventional delivery methods.”[2]
Progressing the program is the company’s priority initiative for 2020, but that isn’t the only news drawing investor attention.
XPhyto (CSE: XPHY, OTCQX: XPHYF) is also developing a sublingual thin film infectious disease screening test platform.
“Lab in a tab” for rapid infectious disease detection
As COVID-19 raged across the planet in early 2020, testing for the infectious disease became a top priority in most countries.
Efforts to ramp up testing were often met with problems, ranging from a shortage of the swabs necessary to perform nasal screenings, to a lack of enough trained personnel or labs to perform the tests and interpret the results. That entire process eats up valuable days while the disease progresses in those who are infected.
In late April several points of care (POC) tests were deployed that offered results within minutes, which allowed tests to be conducted anywhere, including airports and schools.
Unfortunately, “these tests are performing terribly,” as Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, testified to a Project on Government Oversight panel.
XPhyto Therapeutics’ biosensor-enabled oral thin film infectious disease rapid detection test may offer a much better solution.
The test is based on the relatively new development of biosensors, which are powerful and innovative sensors that convert a biological response into an electrical signal.
These sensors are so small that they can be applied to a thin film platform that is then dissolved as a small tab under the tongue, where it can detect the presence of pathogens in the saliva.
No lab is necessary to process the test, and no technicians are necessary to administer it. Rather, it is a “lab in a tab” that should be inexpensive, portable, provides near-instantaneous results, and can be self-administered anywhere.
From COVID-19 to annual flu outbreaks
As we are witnessing today, global pandemics of infectious disease continue to periodically threaten the survival of entire populations.
In the first five months of 2020 more than five million people were infected by the COVID-19 coronavirus, resulting in a third of a million deaths.
And it’s far from over. The U.S. Department of Defense reports that “we have a long path ahead,” with the pandemic continuing to spread through 2021.
The U.S. Centers for Disease Control reports that even in a normal year, 15 million people die of infectious disease globally.
All of which makes the need for new diagnostic testing platforms critical.
The Infectious Disease Society of America states that “Despite advances in diagnostic technology, there is an urgent need for tests that are easy to use, identify the microbe causing the infection, determine whether it is drug-resistant, and provide results faster than current tests.”
The market for infectious disease diagnostics is enormous, with research firm Markets and Markets forecasting that it will reach $19.35 billion by 2022.
XPhyto’s thin-film biosensor-enabled rapid detection test is currently being designed for COVID-19 detection. The company is also adapting the test for seasonal flu. And down the road, XPhyto (OTC: XPHYF) foresees commercializing the testing platform for other infectious diseases.
In order to rapidly progress the development of the test, XPhyto is partnering with German biotech 3a-Diagnostics, a leader in biosensor development and diagnostics.
3a-Diagnostics is providing XPhyto with its pathogen-specific peptide biosensors for use with XPhyto’s thin films. Peptides are most commonly used as probes in biosensors because of their versatility in forming various tertiary structures that interact with numerous molecules.
In an April 22 news release, XPhyto stated that technical development of the POC screening test for several other indications will progress over Q1 2020, including:
- Formulation development for dissolution of peptide biosensor conjugate
- Application of formula to ODF (oral thin films)
- Analytical evaluation of ODF physical and chemical properties
- Macroscopic and microscopic appearance
- Residual liquid
- Disintegration
- Weight, thickness, elasticity, and elongation
- Degradation/stability profile
- Interactive study (films, packaging, excipients)
German heavyweight and industry leader for beverage program development
In May 2020, XPhyto (CSE: XPHY, OTCQX: XPHYF) announced a standstill and LOI for an exclusive partnership between Bunker and Oettinger, Germany’s biggest brewer and 11th largest in the world, to create cannabis-based beverages for the European market and beyond.
Just as Corona beer maker Constellation Brands teamed up with cannabis producer Canopy Growth and Molson Coors joined with medical cannabis producer The Hydropothecary Corporation to create and market cannabis beverages, Oettinger chose XPhyto to help bring cannabis-based beverages to market.
Oettinger is consistently one of the best-selling beers in Germany, holding the number one spot from 2004 till 2013 when they fell to second and kept that position. Their distribution network extends to more than 100 countries.
Top 6 reasons to own XPhyto Therapeutics (CSE: XPHY, OTCQX: XPHYF) now
- XPhyto is solving CBD’s bioavailability problem with a unique, proprietary sublingual thin-film technology that 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 XPhyto’s thin-film platform.
- XPhyto’s epilepsy drug in the final stages of development and 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.
- XPhyto’s business model includes applying its thin-film platform to off-patent drugs previously approved by the FDA, thus creating better, more bioavailable versions while bypassing costly clinical trials before commercialization.
- XPhyto is developing a biosensor-enabled oral thin film infectious disease rapid detection test for both COVID-19 and the flu, with plans to also adapt the platform for other infectious diseases. The market for infectious disease detection is projected to reach $19.35 billion by 2022.
- XPhyto appears close to locking down an exclusive partnership with Germany’s second largest brewer, Oetinger, for the development and commercialization of cannabis-based beverages throughout the European region and beyond. The global cannabis beverages market is expected to reach $2.8 billion by 2025.
- XPhyto is an attractive buyout target in an exploding industry that is being eyed hungrily by food, tobacco, and pharmaceutical companies. With XPhyto’s thin-film technology delivering vastly higher bioavailability, their epilepsy and infection disease products already in final stages of development, and their access to the German and European markets, XPhyto is sure to gain the interest of major players both inside and outside the cannabis industry.
Ask your broker about XPhyto Therapeutics (CSE: XPHY, OTCQX: XPHYF) today. And remember to always do your own due diligence before buying any stock.
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