LEXXW - Lexaria Granted Strategically Important New US Patent for DehydraTECH-Nicotine Including Oral Pouch Products
(TheNewswire)
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More countries are banninge-cigarettes as novel oral products gain traction
Kelowna, British Columbia – TheNewswire - July 19, 2023 –Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the “Company” or “Lexaria”), a globalinnovator in drug delivery platforms announcesit has been granted a strategically important new patent in the oralnicotine sector by the United States Patent and Trademark Office(“USPTO”).
US patent #11,700,875 Compositions and Methods For SublingualDelivery of Nicotine includes claims for manytypes of nicotine, including nicotine benzoate, nicotine ditartrate,nicotine citrate, nicotine polacrilex, and many others, for use insublingual delivery formats like oral pouches. Lexaria’s superior DehydraTECH processing and sublingualcompositions have now been recognized not only through exceptionalscientific study results, but also by the USPTO.
DehydraTECH-nicotine has already shown in multiple setsof animal testing that it can be delivered to the bloodstream up to 10-times to 20-timesfaster at up to 10-fold higher levels ofnicotine into blood plasma from oralabsorption than concentration matched controls. Speed of onset is ofvital importance to nicotine users.
This US-awarded patent is also progressing as a patentapplication through other jurisdictions internationally. This USpatent award and the international patent applications are supportedin part by the superior pharmacokinetic blood plasma data generated byLexaria in its animal studies conducted from 2017 through 2021.Lexaria considers the work completed by competitors to besubstantially inferior when it is limited to indirect theoreticalextrapolations of nicotine absorption into the bloodstream and/orsubjective commentary from small numbers of people, as opposed toLexaria’s rigorous scientific examinations.
Lexaria's new patent builds nicely upon its growingpatent portfolio in the oral nicotine delivery sector including thewhite pouch category for both sublingual and buccal tissue delivery,together with its previous patent filings specific to nicotine datingback to 2019, as well as its foundational DehydraTECH patent filingsdating back to 2016.
The oral nicotine pouch category is of intense interestto Lexaria and the nicotine products industry, and its growth is duein part to its reduced risk healthoutcomes as noted by the Food andDrug Administration. This delivery method, in the white pouch format specifically, whichavoids harmful lung outcomes experienced by smokers or vapers,involves absorption primarily through the buccal and sublingualtissues of the mouth, of purified nicotine that has been separatedfrom most other harmful compounds in the tobacco leaf. The globalmarket for the oral nicotine pouch category was US$4.69 billion in2022 and is growing at a rapid CAGR of 13.4% and is expected to reach $11.91billion in 2029.
Meanwhile, at least 37 countries have bannedthe selling of e-cigarettes , thedevices used in vaping. This represents a cumulative population ofover 2.3 billion people. Nicotine vaping wasoriginally hoped to help wean people off cigarette use but has hadmixed results in doing so, and vaping has also been associated withserious health risks. Nicotine vaping is becoming increasinglycontroversial and is severely limited in certain countries and was,for instance, recently banned inAustralia and is either banned orrestricted in many othercountries .
Lexaria’s DehydraTECH-nicotine is now patent grantedfor oral nicotine delivery in the U.S., Canada and Australia, andpending in numerous other countries. The white pouchcategory is one of the fastest growing, tobacco-freealternatives to smoking and vaping.White pouches emit no smoke, odors or vapor that can affect nearbypersons and are therefore a superior personal nicotine deliverymethod.
The dangers of cigarette smoking are well known andresult in the death of 7 million people peryear . Lexaria’s DehydraTECH-poweredpurified nicotine white pouch formulation contains no tobacco.
Nicotine Plasma Levels(ng/mL) - DehydraTECH vs. Control From Lexaria’s NIC-A21-1Study
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream through oral delivery. Since2016, DehydraTECH has repeatedly demonstrated the ability to increasebio-absorption with cannabinoids, antiviral drugs, PDE5inhibitors and more. DehydraTECH has alsoevidenced an ability to deliver some drugs more effectively across theblood brain barrier. Lexaria operates a licensed in-house researchlaboratory and holds a robust intellectual property portfolio with 35patents granted and many patents pending worldwide. For moreinformation, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS
This press release includes forward-looking statements.Statements as such term is defined under applicable securities laws.These statements may be identified by words such as"anticipate," "if," "believe,""plan," "estimate," "expect,""intend," "may," "could,""should," "will," and other similar expressions.Such forward-looking statements in this press release include, but arenot limited to, statements by the company relating the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company's best judgment based upon current informationand involve a number of risks and uncertainties, and there can be noassurance 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 realizethe benefits thereof, delays or cancellations of planned R&D thatcould occur related to pandemics or for other reasons, and otherfactors which may be identified from time to time in the Company'spublic announcements and periodic filings with the US Securities andExchange Commission on EDGAR. The Company provides links tothird-party websites only as a courtesy to readers and disclaims anyresponsibility for the thoroughness, accuracy or timeliness ofinformation at third-party websites. There is no assurance that any ofLexaria’s postulated uses, benefits, or advantages for the patentedand patent-pending technology will in fact be realized in any manneror in any part. No statement herein has been evaluated by the Food andDrug Administration (FDA). Lexaria-associated products are notintended to diagnose, treat, cure or prevent any disease. Anyforward-looking statements contained in this release speak only as ofthe date hereof, and the Company expressly disclaims any obligation to update any forward-lookingstatements or links to third-party websites contained herein, whetheras a result of any new information, future events, changedcircumstances or otherwise, except as otherwise required bylaw.
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