The company, which specializes in innovative drug delivery platforms, said Altria now has non-exclusive license rights to use DehydraTECHTM drug delivery technology for both the US and worldwide markets under a predefined royalty structure payable to Lexaria Nicotine.
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Altria owns 16.67% of Lexaria Nicotine and one seat of its board in connection with Altria's funding of Lexaria's nicotine research & development (R&D) program in 2019, while Lexaria owns the remaining 83.33% stake.
The R&D program, which was initiated to evaluate oral nicotine delivery performance of an earlier 2018 DehydraTECH oral nicotine formulation, showed in primary results related to the early-stage DehydraTECH formulation that it has demonstrated acceptable chemical and microbiological stability and is well tolerated in a seven-day, repeat-dose acute toxicology study in rats, as well as creating no issues with throat burn and irritation in oral pouch and chew formats at standard commercial doses upon small scale sensory analysis in humans.
The company also said that Altria has not exercised its first warrant tranche to invest a further staged payment into Lexaria Nicotine and as a result that warrant had expired along with Altria's former exclusive access to DehydraTECH for the US market, at 11:59 pm on October 8, 2020.
"The research program initiated in 2019 with Altria significantly advanced our understanding of our patented DehydraTECH drug delivery technology and indirectly led to additional advancements we are already exploiting in other market sectors. We have since entered a R&D framework agreement with an international leader in the nicotine market and look forward to additional developments in advancing reduced-risk methods of oral nicotine delivery through our newly strengthened ability to serve the US market," Lexaria chief executive Chris Bunka said in a statement.
Lexaria also said it “strongly supports” the use of orally-delivered nicotine products as a sensible alternative to combusted tobacco and believes DehydraTECH will play an important role in this alternative following the first-ever modified tobacco product ruling by the US Food and Drug Administration (FDA) in October 2019. The FDA allowed claims for these products that using these products "instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis”.
The company added that it is continuing to advance its R&D programs and showcase its advanced technology to tobacco, nicotine, and pharmaceutical companies and is also seeking to expand its portfolio and caliber of research collaborators and commercial partners.
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