ZANOPRIMA LIFESCIENCES FILES PATENT INFRINGEMENT ACTION AGAINST HANGSEN INTERNATIONAL TO ENFORCE ITS GROUNDBREAKING ENZYMATIC PROCESS FOR SYNTHESIZING (S)-NICOTINE

WACO, Texas, March 17, 2022 /PRNewswire/ -- Zanoprima Lifesciences Ltd. filed a Complaint for Patent Infringement against Hangsen International Group Ltd. ("Hangsen") in the U.S. District Court in the Western District of Texas, Civil Action No. 22-cv-00268 ("Complaint"). In its Complaint, Zanoprima Lifesciences alleges that Hangsen has violated its patent entitled "Process for Making (S)-Nicotine," (U.S. Patent No. 10,913,962) ("Zanoprima's Patent") through Hangsen's manufacture and importation into the U.S. market products containing synthetic nicotine that are manufactured using Zanoprima Lifescience's patented and groundbreaking process.

Zanoprima Lifesciences ("Zanoprima") is the first company to manufacture and make commercially available an enzymatically synthesized form of pure (S)-nicotine – SyNic™ – that is chemically identical to that derived from a tobacco plant but devoid of harmful tobacco-specific nitrosamines, carcinogens, alkaloids, and other impurities that accompany tobacco-derived nicotine. SyNic™ is the purest form of nicotine – over 99% (S)-nicotine – on the market.

Ashok Narasimhan, CEO of Zanoprima, stated, "Over many years, Zanoprima has invested substantial time, resources, intellectual capital, and scientific expertise into developing Zanoprima's groundbreaking enzymatic patented process for synthesizing an (S)-nicotine that is devoid of tobacco-specific nitrosamines and other impurities. Zanoprima's legal action reflects our company's dedication to vigorously protecting our intellectual property in the U.S. and around the world." 

Zanoprima's Patent includes as Claim 1, "A process of making (S)-nicotine comprising the steps of: (i) reducing myosmine with an enzyme with imine reductase activity to form (S)-nornicotine; and (ii) methylating the (S)-nornicotine formed from step (i) to form (S)-nicotine; wherein step (ii) is carried out by way of reductive methylations; and wherein in step (ii) the (S)-nornicotine is reductively methylated, using formaldehyde or a formaldehyde-based compound in the presence of a reductant."

Zanoprima's Complaint alleges that, after publication of Zanoprima's Patent, Hangsen filed a Chinese Patent Application describing a process that copied the process invented by Zanoprima. But, as alleged in the Complaint, Hangsen's patent application was rejected by the Chinese Patent Office in June 2021 citing Zanoprima's patent as prior art. The Complaint also alleges Hangsen imports into the U.S. from China and sells products containing "alleged high-purity synthetic (S)-nicotine and nicotine products that are marketed and sold under various names including as MOTiVO Synthetic S-Nicotine," and that such imported products "are manufactured by a process that practices every step of claim 1" of the Zanoprima Patent.

In addition to seeking damages for infringement, Zanoprima's Complaint seeks preliminary and permanent injunctive relief to prevent Hangsen from continuing its infringing actions.

"Zanoprima Lifesciences' process for manufacturing SyNic™ represents a technological innovation that provides a fully traceable (S)-nicotine, with high levels of enantiomeric and chemical purity, which is commercially available at prices that rival that of tobacco-derived nicotine. Further, SyNic™ represents the greatest opportunity to facilitate the movement towards a tobacco free world, enabling all companies, including pharmaceutical companies making nicotine-replacement therapies, to meet their ESG goals through reduced dependence on tobacco-derived nicotine," Mr. Narasimhan said.  

About Zanoprima Lifesciences Ltd.: Zanoprima Lifesciences, a U.K. based company, was founded in June 2014 by Ashok Narasimhan and Nicholas Hyde with the aim of reducing tobacco-related harm by designing and developing replacement products. The vision for Zanoprima arose from concern in the pharmaceutical industry regarding the provenance and purity of tobacco-derived nicotine being used in the same products intended to reduce addiction to tobacco as well as disease and death associated with tobacco. Zanoprima's SyNic™ is manufactured to meet or exceed U.S. Pharmacopeia standards in an FDA-approved facility that fully complies with CGMP standards. SyNic™ is available for use in a wide variety of recreational nicotine and nicotine replacement therapy products such gums, lozenges, patches, modern oral nicotine products, electronic nicotine delivery systems, and heat not burn devices. Learn more at www.zanoprima.com.

SOURCE Zanoprima Lifesciences Ltd.

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