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Achieve Announces Two Patents Granted by USPTO for Novel Cytisinicline Dosing and Administration Regimen
SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 11, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 11, 2021 / 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 (USPTO) has issued U.S. Patent No. 11,083,715 and U.S. Patent No. 11,083,716 covering the novel 3.0 mg three times daily (TID) cytisinicline dosing regimen.\"We are pleased the USPTO has officially granted these patents as the 3.0 mg TID dosing regimen demonstrated improved efficacy and safety compared to the traditional cytisinicline dosing in our ORCA-1 Phase 2 trial,\" commented John Bencich, Chief Executive Officer of Achieve. \"Upon approval of cytisinicline in the United States, we expect these patents would be eligible for inclusion in the FDA's Orange Book and could provide us marketing exclusivity for the TID cytisinicline dosing regimen until at least the third quarter of 2040.\"The patents include claims covering the expected 3.0 mg commercial dose of cytisinicline administered TID and stem from results obtained in the ORCA-1 clinical study that evaluated various doses and administrations of cytisinicline. The allowed claims cover this novel dose and administration method for the treatment of nicotine addiction and for promoting a reduction and/or cessation in smoking and vaping in treatment naïve and refractory patients who have failed previous smoking cessation treatments. Not including any patent term extensions to which Achieve may be entitled, the patents will expire in the third quarter of 2040.Achieve recently announced completion of enrollment in the Phase 3 ORCA-2 clinical trial, evaluating 3.0 mg cytisinicline TID as a treatment for combustible cigarette cessation. Topline results from the ORCA-2 trial are expected in the first half of 2022. For more information on Achieve Life Sciences and cytisinicline please visit www.achievelifesciences.com.About Achieve and Cytisinicline Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary hear...