BOTHELL, Wash and VANCOUVER, British Columbia, Oct. 26, 2017 — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today announced it has entered into an exclusive supply agreement with Sopharma AD (BSE: 3JR, WSE: SPH) for the manufacture of cytisine active pharmaceutical ingredient (API) and finished tablets.
Under the terms of the agreement, Sopharma agrees to produce cGMP-grade cytisine for Achieve’s use in the development and commercialization of cytisine. Sopharma has over 15 years of experience producing cytisine through its commercialization efforts in in Central and Eastern Europe. In addition, Achieve will have full access to the cytisine supply chain and Sopharma will manufacture sufficient cytisine to meet specified forecasted demand of cytisine in the Achieve territories. The exclusive license agreement provides supply of cytisine to Achieve for up to 20 years.
“This agreement with Sopharma reinforces our commitment and ability to bring cytisine forward as a new treatment option to help the millions of smokers who are battling nicotine and tobacco addiction,” said Rick Stewart, Chairman and CEO of Achieve. “We look forward to our continued partnership with Sopharma as we work together to address this global public health epidemic that claims the lives of more than six million people annually worldwide.”
Achieve recently announced completion of enrollment in a clinical study evaluating the effect of food on the bioavailability of 3mg cytisine and commencement of a multi-dose, PK/PD clinical study. Data from both trials will be used to further inform the Phase 3 clinical program, which is expected to begin enrollment in the United States in mid-2018.
Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisine. Tobacco use is currently the leading cause of preventable death and is responsible for nearly six million deaths annually worldwide. It is estimated that 28.6% of all cancer deaths in the U.S. are attributable to cigarette smoking.
Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment tha