Achieve Life Sciences (ACHV) Announces Allowance of U.S. Patents for Dosing and Administration of Cytisinicline for the Treatment and Prevention of Addiction

June 3, 2021 6:25 AM EDT

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Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced that the United States Patent and Trademark Office has allowed U.S. Patent Application No. 16/993,522 (the ‘522 Application) and U.S. Patent Application No. 17/101,686 (the ‘686 Application) covering the novel 3.0 mg three times daily (TID) cytisinicline dosing regimen.

The '522 and ‘686 Applications include claims covering the expected 3.0 mg commercial dose of cytisinicline administered three times daily. The allowed claims cover this novel dosing regimen and administration method for the treatment of nicotine addiction and for promoting a reduction and/or cessation in smoking and vaping in treatment na�ve and refractory patients who have failed previous smoking cessation treatments. Upon approval of cytisinicline by the U.S. Food and Drug Administration (FDA), the Company anticipates these patents would be included in the FDA's Orange Book which lists approved drugs and related patent and exclusivity information. Once issued, and not including any patent term extensions to which Achieve may be entitled, the patents arising from the ‘522 and ‘686 Applications will expire in the third quarter of 2040.

"We are excited to see the allowance of these patent applications covering the 3.0 mg TID dose and administration that we are investigating in our Phase 3 ORCA-2 study," commented John Bencich, Chief Executive Officer of Achieve. "Based on the current development plans, we believe these patents will be critical components of the overall intellectual property strategy protecting our cytisinicline program in the United States."

Achieve is currently recruiting smokers to participate in the ORCA-2 Phase 3 clinical trial, which is expected to complete enrollment by the middle of 2021. In the previous, dose-finding ORCA-1 trial, 50% biochemically confirmed quit rates at the end of treatment were observed in smokers who received the 3.0 mg TID cytisinicline treatment, compared to 10% for those on placebo (P<0.0001). Cytisinicline was well-tolerated with no serious or severe adverse events reported.



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