The US pharmaceutical company Achieve Life Sciences (NASDAQ: ACHV) has entered into an exclusive supply agreement with leading pharmaceutical producer Sopharma (3JR BU) to manufacture cytisine active pharmaceutical ingredient (API) and finished tablets, according to a statement by Achieve.
How smoking cessation cytisine based drug Tabex made entrance in US
In 2015, Achieve acquired from Sopharma the right to market its smoking cessation cytisine based drug Tabex in the US. In August 2017, Achieve filed an Investigational New Drug application with the US FDA and commenced a cytisine clinical development program in preparation to initiate a Phase 3 trial in the US in 2018.
Under the current exclusive supply agreement Sopharma agrees to produce cGMP-grade cytisine for Achieve’s use in the development and commercialization of cytisine. 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.
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.
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 over 20 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.
Although last two months were going negative for the Bulgarian bourse main index SOFIX, Sopharma stock (3JR BU) still draws 39% on the upside for a period of 1 year. YTD result is also positive registering 35% gains for the shares. Sopharma is included in SOFIX.