Achieve Announces Allowance of U.S. Patents for Dosing and Administration of Cytisinicline for the Treatment and Prevention of Addiction

SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / June 3, 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 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 naïve 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.

For more information on cytisinicline or the ORCA-2 trial, please visit www.achievelifesciences.com or www.orca-2.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 heart disease are attributable to smoking and exposure to secondhand smoke.² Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the FDA for any indication in the United States. Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 17 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

Forward-Looking Statements
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 cytisinicline clinical development activities, the potential issuances of patents, the ability to provide patent protection for Achieve's cytisinicline program, the potential listing of the patents in the FDA's Orange Book, the potential market size and 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 that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve's filings 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 undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media Contact
Glenn Silver
Glenn.Silver@Finnpartners.com
(646) 871-8485

Investor Relations Contact
Jason Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4

References

¹ World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.

² U.S. Department of Health and Human Services. The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General, 2014.

Released June 3, 2021