LXRP - Lexaria Bioscience Advances 2021 Strategic Initiatives
(TheNewswire)
Lexaria Focusingon Four Core Business Segments:
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- Heart disease includinghypertension
- Reduced-risk non combustednicotine
- Improved antiviral drugdelivery
- CBD from hemp
Kelowna, British Columbia - TheNewswire - November 5, 2020 -Lexaria Bioscience Corp. (OTC:LXRP) (CSE:LXX) (CNSX:LXX.CN) (the "Company"or "Lexaria"), a global innovator in oral drug deliveryplatforms, is pleased to outline its plannedstrategic initiatives for 2021 with a sharply enhanced focus on solutions relatedto the regulated pharmaceutical and medical market segments where itbelieves its patented technology will offer the highest value andutility .
Lexaria will concentrate its patented DehydraTECH drugdelivery technology on four core areas of business with out-licensingstrategies to existing drug manufacturers:
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- Heart disease including hypertension utilizingCBD;
- Reduced-risk methods of delivering non-combustednicotine;
- Improving antiviral drug delivery for applicationsthat include Covid-19, influenza, herpes, hepatitis and AIDS;and
- Hemp-based CBD business-to-business ("B2B")applications for non-pharmaceutical consumer and therapeutic ormedicinal products and prospective pharmaceutical indications beyondhypertension.
HEART DISEASE AND HYPERTENSION
The current global market size for drugs used to treatvarious heart diseases is $47.29 billion (1) , andanticoagulants, antihypertensive, and antihyperlipidemic drugscomprise roughly 90% of these. Broad trends including agingpopulations and obesity are expected to contribute to growth in demandfor heart disease-related drugs, where demand is expected to reach$63.96 billion by 2026 (2) .
Cardiovascular disease caused 840,678 deaths in the USduring 2016 and more than one-third of all Americans suffer from someform of cardiovascular disease. The three leading companies in thecardiovascular drug market are thought to be Bristol-Myers Squibb;Pfizer, and Janssen Pharmaceuticals.
Lexaria has already demonstrated in a pilot humanclinical study, published in a peer-reviewed medical journal in 2019,that its DehydraTECH processed cannabidiol (CBD) was associated with astatistically significant slight decrease in human blood pressure,theorized to have occurred as a result of the known vasodilatorypotential of CBD. As a complex fat-soluble molecule, generic CBD isknown to have poor absorption characteristics, such that typicallyonly about 6% of what is orally ingestedactually finds its way into blood circulation. Lexaria's technologyhas shown an ability to increase this absorption into the bloodcirculation by between 100% to 500%.
Lexaria is expecting to commence a second exploratoryhuman clinical study intended to corroborate and expand on thefindings of the original pilot study. Clinical test articles have beenmanufactured and are ready for shipment to the clinical site pendingregulatory clearance for importation purposes. If this study issuccessful, Lexaria will then begin systematic outreach to some of theworld's participants in the cardiovascular disease drug industry tointroduce DehydraTECH's enhancement technology.
Lexaria's DehydraTECH is patent granted in the EuropeanUnion and Australia for treatment of heart disease utilizing CBD, andthe Company continues to seek international expansion of its patentprotection utilizing CBD throughout the world.
REDUCED RISK NON-COMBUSTEDNICOTINE
Through a series of animal and human volunteer studies,Lexaria has repeatedly evidenced that its DehydraTECH technologysignificantly increases both the speed and ability of orallyadministered nicotine to reach the blood circulatory system and tocross the blood brain barrier. Lexaria's own limited human testingutilizing its most recent 2020 powdered nicotine formulations appearto demonstrate nicotine absorption and onset of nicotine effectivenessin as little as 1.5-4 minutes after an oral dose.
The global tobacco market is expected to be valued at$1.08 trillion by 2027 (3) , making it one of the largest industriesin the world. Combustible tobacco demand is shrinking by 2% per year,while demand for non-combusted alternative is growing at approximately10% per year. The nicotine replacement therapy market size in 2019 was$2.55 billion and is expected to reach $3.54 billion by2027 (4) .
There are an increasing number of alternatives tocombustible tobacco experiencing dramatic growth in demand asconsumers search for reduced risk method nicotine options, includingthe e-cig market, currently valued at $12.41 billion and projected toreach $68.48 billion by 2027; as well as the nicotine oral pouchmarket, currently valued at $2.37 billion and expected to reach $32.77billion by 2026. (5) Products in the oral pouch category werethe first nicotine products in the history of the Food and DrugAdministration (the "FDA") to be authorized through theModified Risk Tobacco Product pathway approved for claims of a lowerrisk of mouth cancer, stoke, lung disease, heart disease, emphysemaand chronic bronchitis than cigarettes.
Lexaria has been successful in developing relationshipswith two of the world's largest tobacco companies, Altria Ventures Incand British American Tobacco. Lexaria has also engaged in businessdialogue with other tobacco and nicotine companies located in variousparts of the world. Lexaria's DehydraTECH is patent granted in theUSA, the European Union and Australia for oral delivery of nicotine.
ANTIVIRAL DRUGS
Early in 2020 Lexaria initiated early-stage researchinto the prospective applicability of DehydraTECH technology relatedto improved delivery characteristics of a number of existing antiviral drugs. Because DehydraTECH hasrepeatedly evidenced an ability to more efficiently deliverlipophilic CBD and nicotine, Lexaria first began postulating in 2019that the technology may have applicability for a range of applicationsin the traditional pharmaceutical sector.
Viral-caused diseases such as HIV, hepatitis,influenza, and coronavirus remain common and at times reach pandemicproportions. Hepatitis caused 1.3 million deaths in 2015 (6) ; influenzahad 13 million cases reported in 2019 in the US alone; Covid-19 hasinfected over 48 million people worldwide during 2020 and is currentlyinfecting more than one-half million people per day. Additionally,there are currently 37.9 million people worldwide infected withHIV/AIDS.
Vaccines help prevent the transmission of, - but do nottreat - viral diseases and generally have effectiveness rates ofbetween 50% and 80%. Antiviral drugs will always be needed to treatpeople who become infected and are at risk of serious healthconsequences with viral diseases, and in many cases are the differencebetween life and death. The antiviral drug market is currently $52.2billion and expected to grow to $75.3 billion by 2027 (7) . Some of thelargest companies competing in the antiviral drug market includeAbbvie; Gilead Sciences; GlaxoSmithKline; and Merck and Co.
Many antiviral drugs are currently administered viainjection, a process usually requiring a health care professional thatintroduces expense and complication for mass dosing. Lexaria believesit is possible that DehydraTECH could improve delivery performancesuch that some of these drugs could be dosed via oral tablet orcapsule which is less expensive and makes it easier and less expensiveto treat more patients in less time. To date, DehydraTECH has beenclinically studied only with CBD and nicotine as potential activepharmaceutical ingredients ("APIs") and the results of thesestudies may not be predictive of the results of subsequent trialsincorporating other APIs. Therefore, we are not certain if DehydraTECHwill improve delivery of or be compatible with existing or futureantiviral therapies, including those used to treat COVID-19.
Lexaria has designed a human clinical pilot study totest the effectiveness of DehydraTECH in delivering higher proportionsof antiviral drug into the human blood stream, versus otherwiseidentical non DehydraTECH-processed antiviral drugs. Hospital ethicsboard approval has been received to conduct this study, conditional onfurther federal government approval which the Company is evaluatingthe necessary steps to pursue.
Lexaria has significantly advanced an early-stageR&D-focused rodent based pharmacokinetic ("PK") study totest DehydraTECH's ability to deliver a higher proportion of existingantiviral drugs into animal blood circulation with animal dosingalready completed and data analyses expected to commence shortly. Forboth the human study and the animal study, two drugs have beenselected that are representative of two leading possible classes ofdrugs currently being examined by others as potential treatments forCOVID-19. PK study outcomes are almost always needed as part of a datapackage to present to established drug companies in hopes of futurecollaboration. Lexaria's technology is currently patent pending foruse with antiviral drugs.
Lexaria has previously reported growth in its CBD B2B processing division of more than 500% thisyear between its fiscal 4 th quarter ended August 31, 2020 and fiscal1 st quarter ending November 30, 2020. Third partycorporate demand for DehydraTECH to improve the delivery andperformance characteristics of CBD has exceeded expectations. Lexariahas previously sold direct-to-consumer CBD-related products of onlythousands of servings per quarter. Demand from corporate purchasersfor DehydraTECH-enabled CBD powders, in contrast, is expected toexceed 8 million servings during the current quarter and is expectedto continue to rise into 2021. As a result, Lexaria's hemp businessdivision intends to discontinue the sale of its direct-to-consumerCBD products and will focus on the high-growth B2B CBD powderprocessing segment, and on continued out-licensing of its intellectualproperty to generate royalty revenues from third-party companiesseeking to improve their consumer's experiences by utilizing Lexaria'stechnology for their hemp derived CBD product offerings.
The global CBD market was estimated at $4.6 billion in2018, growing rapidly and expected to reach $23.6 billion in2025 (8) . Although the CBD market size is smaller than the otheropportunities under pursuit by the Company, the Company's technologywas first developed to enhance the delivery of CBD and the Company hasan established business presence within the sector that isexperiencing revenue growth.
Many studies are underway around the worldinvestigating CBD for potential treatment of several medicalconditions including opioid and other substance abuse, anxiety andmore. In harmony with the increased scientific investigation, CBD isalso gaining recognition as a regulated drug with significant medicalpotential. For example, Epidiolex generated $296 million inrevenue (9) for its owner, GW Pharmaceuticals, during 2019. Epidiolex isregulated by the FDA as a treatment for certain forms of childhoodepilepsy, a central nervous system disorder.
Lexaria's DehydraTECH is patent granted in the EuropeanUnion and Australia for treatment of a range of central nervous systemdisorders using CBD and, as previously noted, Lexaria continues toseek international expansion of its patent protection utilizingCBD.
Chris Bunka, CEO, is responsible for the accuracy ofthis news. The Company is notmaking any express or implied claims at this time that its products ortechnology have the ability to eliminate, cure or contain Covid-19 (orSARS-2 Coronavirus) nor any other therapeutic drugindication.
About Lexaria
Lexaria Bioscience Corp.'s (OTCQX: LXRP, CSE: LXX)proprietary drug delivery technology, DehydraTECH(TM), improves theway active pharmaceutical ingredients (APIs) enter the bloodstream bypromoting healthier oral ingestion methods and increasing theeffectiveness of fat-soluble active molecules, thereby loweringoverall dosing. The Company's technology can be applied to manydifferent ingestible product formats, including foods, beverages, oralsuspensions, tablets, and capsules. DehydraTECH increasesbio-absorption by up to 5-10x, reduces time of onset from 1 - 2 hoursto minutes, and masks unwanted tastes for orally administeredbioactive molecules, including anti-virals, cannabinoids, vitamins,non-steroidal anti-inflammatory drugs (NSAIDs),nicotine, and other molecules. Lexaria has licensed DehydraTECH tomultiple companies including a world-leading tobacco producer for thedevelopment of smokeless, oral-based nicotine products and for use inindustries that produce cannabinoid beverages, edibles, and oralproducts. Lexaria operates a licensed in-house research laboratory andholds a robust intellectual property portfolio with 18 patents grantedand approximately 60 patents pending worldwide. For more information,please visit www.lexariabioscience.com.
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1 https://www.fortunebusinessinsights.com/industry-reports/cardiovascular-drugs-market-100379
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3 https://www.grandviewresearch.com/press-release/global-tobacco-market
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8 https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market
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FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements. Statements as suchterm is defined under applicable securities laws. These statements maybe identified by words such as "anticipate," "if,""believe," "plan," "estimate,""expect," "intend," "may,""could," "should," "will," and othersimilar expressions. Such forward-looking statements in this pressrelease include, but are not limited to, statements by the companyrelated to strategic plans for 2021 and successfully executing itsfour core areas of business focus. Such forward-looking statements areestimates reflecting the Company's best judgment based upon currentinformation and involve a number of risks and uncertainties, and therecan be no assurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors which could cause actual resultsto differ materially from those estimated by the Company include, butare not limited to, government regulation and regulatory approvals,managing and maintaining growth, the effect of adverse publicity,litigation, competition, scientific discovery, the patent applicationand approval process, potential adverse effects arising from thetesting or use of products utilizing the DehydraTECH technology, theCompany's ability to maintain existing collaborations and realize thebenefits thereof, and other factors which may be identified from timeto time in the Company's public announcements and periodic filingswith the US Securities and Exchange Commission on EDGAR. There is noassurance that existing capital is sufficient for the Company's needsor that it will be able to raise additional capital. There is noassurance the Company will be capable of developing, marketing,licensing, collaborating with third parties or selling any productscontaining any active ingredient or drug. There is no assurance thatany planned corporate activity, research and development, scientificresearch or study, business venture, letter of intent, technologylicensing pursuit, patent application or allowance, consumer study, orany initiative will be pursued, or if pursued, will be successful:industry-wide, these initiatives often fail and, in some cases, mayrequire amendments, revisions or repeating as appropriate to reachsuccessful outcomes. There is no assurance that any of Lexaria'spostulated uses, benefits, or advantages for the patented andpatent-pending technology will in fact be realized in any manner or inany part or be defensible. No statement herein has been evaluated bythe Food and Drug Administration (FDA). Lexaria-associated productsare not intended to diagnose, treat, cure or prevent any disease.
Any forward-looking statements contained in this release speak only asof the date hereof, and the Company expressly disclaims any obligationto update any forward-looking statements contained herein, whether asa result of any new information, future events, changed circumstancesor otherwise, except as otherwise required by law.
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