Achieve Life Sciences Announces Patent Granted by USPTO for New Cytisinicline Formulation

Rhea-AI Summary

Achieve Life Sciences announced that the USPTO issued U.S. Patent No. 11,459,328 for the mesylate salt formulation of cytisinicline. This patent expands their portfolio, now totaling 18 patents, securing exclusivity until 2040 for its effective 3.0 mg dosing regimen. Achieve is conducting Phase 3 trials (ORCA-3) for smoking cessation and Phase 2 trials (ORCA-V1) for e-cigarette cessation, with topline data expected in Q2 2023. Cytisinicline, a plant-based alkaloid, targets nicotine dependence and has shown promise in clinical settings.

Positive

• Issuance of U.S. Patent No. 11,459,328 enhances intellectual property protection for cytisinicline.
• Total of 18 patents strengthens Achieve's market position with exclusivity until 2040.
• Positive outcomes anticipated in ongoing Phase 3 and Phase 2 trials for smoking and e-cigarette cessation.

Negative

• Cytisinicline is still an investigational product and has not yet received FDA approval.

SEATTLE, Wash and VANCOUVER, British Columbia, Dec. 21, 2022 (GLOBE NEWSWIRE) -- 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 dependence, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,459,328 covering the mesylate salt formulation of cytisinicline and the process for its development.

“Continuing to expand our intellectual patent portfolio around cytisinicline further protects our nicotine dependence franchise,” commented John Bencich, Chief Executive Officer of Achieve. “Including this latest issuance, our family of patents protecting cytisinicline is now 18, including exclusivity until 2040 for the novel 3.0 mg, three-times daily dosing regimen that has been shown to be effective and very well-tolerated in our Phase 3 clinical development program.”

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. Achieve continues to pursue numerous patents that will further enhance the product’s stability and the potential for life cycle expansion via varying methods of administration. 

Achieve is currently conducting the final FDA-registration enabling Phase 3 ORCA-3 trial for smoking cessation and the Phase 2 ORCA-V1 trial evaluating cytisinicline for e-cigarette cessation. The Company continues to expect topline data results for both trials to be announced in the second quarter of 2023. For more information on Achieve Life Sciences and cytisinicline please visit www.achievelifesciences.com.

About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of 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

In addition, there are nearly 11 million adults in the United States who use e-cigarettes, also known as vaping.³ While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.⁴ In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.⁵ Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.⁶ Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.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, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, 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; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises 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.

Investor Relations Contact
Rich Cockrell
achv@cg.capital
(404) 736-3838

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

References
¹World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
²U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
³Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI: 10.15585/mmwr.mm6946a4
⁴Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].
⁵Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.
⁶Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.

FAQ

What recent patent was issued to Achieve Life Sciences regarding cytisinicline?

Achieve Life Sciences received U.S. Patent No. 11,459,328 for the mesylate salt formulation of cytisinicline.

How many patents does Achieve Life Sciences hold for cytisinicline?

Achieve Life Sciences now holds a total of 18 patents protecting cytisinicline.

When are the results for the ORCA-3 and ORCA-V1 trials expected?

Topline data results for the ORCA-3 and ORCA-V1 trials are expected in the second quarter of 2023.

What is cytisinicline and what is its purpose?

Cytisinicline is a plant-based alkaloid focused on aiding smoking cessation and treating nicotine dependence.

Is cytisinicline FDA approved?

Cytisinicline is still an investigational product and has not received FDA approval for any indication in the United States.