Smoking cessation drug Tabex US rights holder Achieve Life Sciences closes merger with OngoGenex Pharmaceuticals, according to a regulatory filing by the latter. Cytisine has been an established treatment produced and marketed in Central and Eastern Europe by Sopharma for 15+ years under the brand of Tabex.
The road of Tabex to US
Leading generic pharma producer Sopharma sold the Tabex drug’s rights to be marketed in the US to Achieve in mid-2015 keeping a minority stake in the company together with various entitlements as Achieve progresses with an U.S. Food and Drug Administration (FDA) registration procedure.
As a result of the merger with OngoGenex Pharmaceuticals, Achieve’s shareholders will become majority shareholders in the company. The combined company will be renamed to Achieve Life Science and carry on as a fully-integrated late-stage smoking cessation company.
Plans for Tabex trials in 2018
The company plans to commence a large-scale, placebocontrolled Phase 3 trial of cytisine (marketed in Bulgaria as Tabex) in the United States within the first-half of 2018.
Achieve is also in collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH) in the US to conduct nonclinical studies of cytisine as a smoking cessation treatment. The latter trials are required by the FDA to support the submission of an Investigational New Drug (IND) application. The results of the initial study are expected in the second quarter of 2017.
Sopharma consolidation continues
Sopharma (3JR BU) and bandages producer Medica (5MA BU) merger was completed, according to a regulatory filing by Sopharma. The merger is effective in the Trade Registry from August 8th, 2017 with Medica ceasing to exist afterwards as all assets and liabilities turn to Sopharma.
Medica produces medical bandages, food additives and prescription and OTC drugs in the southwestern Bulgarian town of Sandanski.
For FY2016, Medica booked BGN 18.4m in revenues, up 6% y/y, and BGN 2.1m in net income, down 3.6% y/y. For 1H17, Medica’s sales are flat at BGN 8.6m while net income is up 20% to BGN 1.1m. The merger will affect both the balance sheet and the income statement of Sophama on a standalone basis but have no effect on a consolidated level.