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Achieve Life Sciences Strengthens Leadership with Appointment of Dr. Mark Rubinstein, Nicotine Dependence Expert, as New Head of Medical Affairs

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Achieve Life Sciences, Inc. (Nasdaq: ACHV) has appointed Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings over 20 years of experience in clinical medicine, scientific research, and medical affairs leadership, with a focus on preventative medicine and nicotine cessation. His expertise aligns with Achieve's mission to provide innovative solutions for nicotine dependence.

Dr. Rubinstein previously served as Head of Medical Affairs at Blip and Vice President of Global Scientific Affairs at Juul Labs. He is Professor Emeritus of Pediatrics at the University of California, San Francisco (UCSF), where he conducted NIH-funded research on nicotine addiction in adolescents and smoking cessation interventions. Dr. Rubinstein's appointment comes as Achieve moves closer to anticipated FDA approval and commercialization of cytisinicline, potentially the first new treatment for nicotine dependence in nearly 20 years.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) ha nominato Dott. Mark L. Rubinstein come nuovo Responsabile delle Questioni Mediche. Il Dott. Rubinstein porta con sé oltre 20 anni di esperienza nella medicina clinica, nella ricerca scientifica e nella leadership in ambito medico, con un focus sulla medicina preventiva e la cessazione dalla nicotina. La sua esperienza si allinea con la missione di Achieve di fornire soluzioni innovative per la dipendenza da nicotina.

Il Dott. Rubinstein ha precedentemente ricoperto il ruolo di Responsabile delle Questioni Mediche presso Blip e di Vicepresidente delle Questioni Scientifiche Globali presso Juul Labs. È Professore Emerito di Pediatria presso l'Università della California, San Francisco (UCSF), dove ha condotto ricerche finanziate dal NIH sulla dipendenza da nicotina negli adolescenti e sulle interventi per la cessazione del fumo. La nomina del Dott. Rubinstein avviene mentre Achieve si avvicina all'attesa approvazione della FDA e alla commercializzazione della cytisinicline, potenzialmente il primo nuovo trattamento per la dipendenza da nicotina dopo quasi 20 anni.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) ha nombrado a Dr. Mark L. Rubinstein como su nuevo Jefe de Asuntos Médicos. El Dr. Rubinstein aporta más de 20 años de experiencia en medicina clínica, investigación científica y liderazgo en asuntos médicos, con un enfoque en la medicina preventiva y la cesación de la nicotina. Su experiencia está alineada con la misión de Achieve de proporcionar soluciones innovadoras para la dependencia de la nicotina.

El Dr. Rubinstein anteriormente se desempeñó como Jefe de Asuntos Médicos en Blip y Vicepresidente de Asuntos Científicos Globales en Juul Labs. Es Profesor Emérito de Pediatría en la Universidad de California, San Francisco (UCSF), donde realizó investigaciones financiadas por los NIH sobre la adicción a la nicotina en adolescentes y las intervenciones para dejar de fumar. El nombramiento del Dr. Rubinstein se produce en un momento en que Achieve se acerca a la esperada aprobación de la FDA y la comercialización de la cytisinicline, potencialmente el primer nuevo tratamiento para la dependencia de la nicotina en casi 20 años.

Achieve Life Sciences, Inc. (Nasdaq: ACHV)는 Dr. Mark L. Rubinstein을 새로운 의학 이사로 임명했습니다. Rubinstein 박사는 예방 의학과 니코틴 중단에 중점을 두고 임상 의학, 과학 연구 및 의학 관련 리더십 분야에서 20년 이상의 경험을 가지고 있습니다. 그의 전문성은 Achieve의 니코틴 의존에 대한 혁신적인 솔루션을 제공하려는 사명과 일치합니다.

Rubinstein 박사는 이전에 Blip에서 의학 이사를 역임했으며 Juul Labs의 글로벌 과학 담당 부사장이었습니다. 그는 캘리포니아 대학교 샌프란시스코(UCSF) 소아과의 명예 교수로, 청소년의 니코틴 중독과 흡연 중단 개입에 대한 NIH 자금을 받은 연구를 수행했습니다. Rubinstein 박사의 임명은 Achieve가 FDA 승인을 기다리고 있으며 cytisinicline의 상용화에 가까워지고 있는 상황에서 이루어졌습니다. cytisinicline은 최근 20년 동안 니코틴 의존에 대한 첫 번째 신규 치료법이 될 가능성이 있습니다.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) a nommé Dr. Mark L. Rubinstein en tant que nouveau Responsable des Affaires Médicales. Le Dr Rubinstein apporte plus de 20 ans d'expérience en médecine clinique, en recherche scientifique et en leadership dans les affaires médicales, avec un accent sur la médecine préventive et l'arrêt du tabac. Son expertise aligne avec la mission d'Achieve de fournir des solutions innovantes pour la dépendance à la nicotine.

Le Dr Rubinstein a précédemment été Responsable des Affaires Médicales chez Blip et Vice-Président des Affaires Scientifiques Globales chez Juul Labs. Il est Professeur Émérite de Pédiatrie à l'Université de Californie, San Francisco (UCSF), où il a mené des recherches financées par les NIH sur la dépendance à la nicotine chez les adolescents et les interventions pour arrêter de fumer. La nomination du Dr Rubinstein intervient alors qu'Achieve se rapproche de l'approbation attendue de la FDA et de la commercialisation de la cytisinicline, qui pourrait être le premier nouveau traitement de la dépendance à la nicotine depuis près de 20 ans.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) hat Dr. Mark L. Rubinstein als neuen Leiter der medizinischen Angelegenheiten ernannt. Dr. Rubinstein bringt über 20 Jahre Erfahrung in der klinischen Medizin, in der wissenschaftlichen Forschung und in der Leitung medizinischer Angelegenheiten mit, wobei der Schwerpunkt auf präventiver Medizin und Nikotinentwöhnung liegt. Seine Expertise steht im Einklang mit der Mission von Achieve, innovative Lösungen gegen die Nikotinsucht anzubieten.

Dr. Rubinstein war zuvor Leiter der medizinischen Angelegenheiten bei Blip und Vizepräsident für globale wissenschaftliche Angelegenheiten bei Juul Labs. Er ist emeritierter Professor für Pädiatrie an der University of California, San Francisco (UCSF), wo er mit NIH-Mitteln geförderte Forschung zur Nikotinsucht bei Jugendlichen und zu Interventionen zur Raucherentwöhnung durchgeführt hat. Die Ernennung von Dr. Rubinstein erfolgt, während Achieve sich der erwarteten Genehmigung durch die FDA und der Kommerzialisierung von Cytisiniclin nähert, das möglicherweise die erste neue Behandlung für Nikotinsucht seit fast 20 Jahren sein könnte.

Positive
  • Appointment of Dr. Mark L. Rubinstein, a nicotine dependence expert, as Head of Medical Affairs
  • Dr. Rubinstein brings over 20 years of experience in clinical medicine, research, and medical affairs leadership
  • Alignment with company's mission to provide innovative solutions for nicotine dependence
  • Progress towards anticipated FDA approval and commercialization of cytisinicline
  • Potential for cytisinicline to be the first new treatment for nicotine dependence in nearly 20 years
Negative
  • None.

SEATTLE and VANCOUVER, British Columbia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, is pleased to announce the appointment of Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, with a strong focus on preventative medicine and nicotine cessation.

As a seasoned medical executive and physician, Dr. Rubinstein’s expertise aligns with Achieve Life Sciences’ mission to provide innovative solutions for those struggling with nicotine dependence. His extensive career spans both academic and corporate settings, positioning him as a leading voice in nicotine addiction research and intervention.

“We are thrilled to welcome Mark to our team at this pivotal time,” said Rick Stewart, CEO of Achieve Life Sciences. “His vast experience in smoking and vaping cessation, combined with his leadership in medical affairs, will play an instrumental role in shaping the future of our initiatives aimed at reducing nicotine dependence and improving public health outcomes.”

Prior to joining Achieve, Dr. Rubinstein served as the Head of Medical Affairs at Blip, where he spearheaded the company’s strategy to help smokers and vapers quit through FDA-approved medications and digital support tools. He was also Vice President of Global Scientific Affairs at Juul Labs, where he led efforts to prevent youth usage of nicotine products.

“I am honored to join Achieve at such an exciting time as we move closer to anticipated FDA approval and commercialization,” said Dr. Rubinstein. “Cytisinicline has the potential to be the first new treatment for nicotine dependence in nearly 20 years, marking a major milestone in the field. I am eager to contribute to the development of this breakthrough therapy, which could provide a crucial, long-awaited solution for those striving to quit nicotine and improve their health.”

Dr. Rubinstein is Professor Emeritus of Pediatrics at the University of California, San Francisco (UCSF), where he served on the faculty for nearly 20 years. His research, funded by the NIH and other prestigious organizations, focused on nicotine addiction in adolescents and smoking cessation interventions, resulting in numerous high-profile studies published in leading scientific journals.

Dr. Rubinstein is also a recognized thought leader and speaker, having been featured in major media outlets including ABC Nightly News, NPR, The New York Times, and The Wall Street Journal. His passion for leveraging digital media to drive health behavior change and improve healthcare outcomes aligns with Achieve Life Sciences’ innovative approach to combating nicotine addiction.

Dr. Rubinstein earned his M.D. from Yale University and completed his residency in Internal Medicine at Yale-New Haven Hospital. He is board-certified in both Internal Medicine and Adolescent Medicine.

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. There are approximately 29 million adults in the United States alone who smoke combustible cigarettes.1 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.2,3 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.3

In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.5 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 the 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 visit the Achieve website.

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 and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, 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 macroeconomic and geopolitical conditions, including inflation, volatile interest rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict 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
1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.
2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.
3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.
5Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182.


FAQ

Who is the new Head of Medical Affairs at Achieve Life Sciences (ACHV)?

Dr. Mark L. Rubinstein has been appointed as the new Head of Medical Affairs at Achieve Life Sciences (ACHV).

What is Dr. Rubinstein's background in nicotine dependence research?

Dr. Rubinstein has over 20 years of experience in clinical medicine and research, with a focus on nicotine addiction in adolescents and smoking cessation interventions. He conducted NIH-funded research at UCSF and has held leadership positions in medical affairs at companies focused on nicotine cessation.

What is the significance of cytisinicline for Achieve Life Sciences (ACHV)?

Cytisinicline has the potential to be the first new treatment for nicotine dependence in nearly 20 years. Achieve Life Sciences (ACHV) is moving closer to anticipated FDA approval and commercialization of this breakthrough therapy.

How does Dr. Rubinstein's appointment align with Achieve Life Sciences' (ACHV) goals?

Dr. Rubinstein's expertise in nicotine dependence and medical affairs leadership aligns with Achieve Life Sciences' (ACHV) mission to provide innovative solutions for those struggling with nicotine dependence and improve public health outcomes.

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