Achieve Announces USPTO Grant of Two Patents for New Cytisinicline Dosing and Delivery Regimen
SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / August 11, 2021 / Go to Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company engaged in the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that the Patent Office and Trademark of the United States (USPTO) issued U.S. Patent No. 11,083,715 and U.S. Patent No. 11,083,716 covering the new regimen of cytisinicline 3.0 mg three times daily (TID).
“We are delighted that the USPTO has officially granted these patents, as the 3.0 mg TID regimen demonstrated improved efficacy and safety over traditional cytisinicline dosing in our ORCA-1 Phase 2 trial.” , commented John Bencich, CEO of Achieve. “Following the approval of cytisinicline in the United States, we anticipate that these patents could be included in the FDA Orange Book and could provide us with market exclusivity for the TID regimen of cytisinicline until at least the third quarter of 2040. “
The patents include claims covering the expected commercial dose of 3.0 mg of cytisinicline administered TID and arise from results obtained in the ORCA-1 clinical study which evaluated various doses and administrations of cytisinicline. The authorized claims cover this new dose and new method of administration for the treatment of nicotine dependence and to promote reduction and / or cessation of smoking and vaping in treatment-naïve and refractory patients who have failed. previous smoking cessation treatments. Excluding any patent term extensions to which Achieve may be entitled, patents will expire in the third quarter of 2040.
Achieve recently announced the completion of enrollment in the ORCA-2 Phase 3 clinical trial, evaluating 3.0 mg of cytisinicline TID as a treatment for smoking cessation. The first results of 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 which is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States each year.1.2 Over 87% of lung cancer deaths, 61% of all lung disease deaths and 32% of all coronary heart disease deaths are attributable to smoking and exposure to second-hand smoke.2 Achieve’s goal is to fight the global epidemic of smoking and nicotine dependence through the development and commercialization of cytisinicline.
Cytisinicline is an alkaloid of plant origin with high binding affinity to the nicotinic acetylcholine receptor. It is believed to help quit smoking by interacting with nicotine receptors in the brain reducing the severity of nicotine withdrawal symptoms and reducing the reward and satisfaction associated with smoking.
Cytisinicline is an investigational product candidate under development for the treatment of nicotine dependence and has not been approved by the FDA for any indication in the United States. Achieve recently announced the completion of recruitment into the phase 3 ORCA-2 trial, evaluating cytisinicline for smoking cessation. The first results of 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.
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of the business of clinical development of cytisinicline, the ability to provide patent protection for Achieve’s cytisinicline program, the potential patent listing in the FDA Orange Book, descriptions of the intended commercial dosage of cytisinicline, size and the potential market acceptance for cytisinicline, the potential benefits of cytisinicline, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements which could be considered as forward-looking statements. Achieve may not actually achieve its plans or product development objectives in a timely manner, if at all, or achieve its intentions or meet its expectations or projections disclosed in such forward-looking statements. These statements are based on the current expectations and beliefs of management and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in forward-looking statements, including including, inter alia, the risk that cytisinicline may not demonstrate hypothetical or expected benefits; the risk that Achieve will not be able to obtain additional funding to finance the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be marketed successfully; the risk that new developments in the smoking cessation landscape will require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property will not be adequately protected; general commercial and economic conditions; and the other factors described in the risk factors set forth in documents filed by Achieve with the Securities and Exchange Commission from time to time, including Achieve’s annual reports on Form 10-K and quarterly reports on Form 10-Q. Achieve assumes no obligation to update any forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, except as may be required by applicable law.
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1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
2 US Department of Health and Human Services. The health consequences of smoking – 50 years of progress. A report from the Surgeon General, 2014.
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