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 that has been approved and marketed in Central and Eastern Europe for more than 15 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including over 2,000 patients in investigator-conducted, Phase 3 clinical trials in Europe and New Zealand.
Two prior, large-scale Phase 3 clinical studies of cytisine, with favorable outcomes, have been successfully completed in over 2,000 patients. The TASC trial was a 740 patient, double-blind, placebo controlled trial conceived by Professor Robert West at University College London and funded by the U.K. National Prevention Research Initiative. The CASCAID trial was a 1,310 patient, single-blind, non-inferiority trial comparing cytisine to nicotine replacement therapy (NRT). The CASCAID trial was conceived by Dr. Natalie Walker, National Institute for Health Innovation, University of Auckland and funded by the Health Research Council of New Zealand. Both trials were published in the New England Journal of Medicine. Learn more at www.achievelifesciences.com
About Sopharma AD
Sopharma is a Bulgarian based EU pharmaceutical producer with over 80 years tradition in the field. The company is a strong regional player and a responsible partner to the Bulgarian government in the health care sector supporting the entire healthcare system and the hospital sector in particular. The product portfolio expands to over 200 products in all main therapeutic areas known in more than 40 markets on 5 c