Sopharma drug closer to US registration


Sopharma’s smoking cessation drug closer to a US registration. The drug, known and sold by Sopharma under the Tabex brand in Central and Eastern Europe, is currently in a final Phase 3 trial conducted by the US based private company Achieve Life Science Inc. Achieve acquired the right to sell it in the US, Mexico, UK, China and Australia from Sopharma in mid-2015.

Merger with US partner ahead

Now, it pairs with US based Oncogenex (Nasdaq: OGXI) to further work on the clinical and commercial development of the cytisine based tobacco addiction cessation drug, both companies announced in a statement last week. They plan to merge with Achieve holding approx. 3/4 of the combined company, ¼ to be for Oncogenex shareholders. The merger is expected be finalized by mid-2017, pending regulatory approval with FDA registration initial steps taken in 2017.

Sopharma to have 3.5% of the newly combined company and should also benefit from any future production of the drug.

Tabex wrapped up successful trials

Tabex has already had two Phase 3 trials over 2 000 patients using cytisine as a smoking cessation program with results published in the New England Journal of Medicine. In total, 10 000 individuals have tested the product while more than 20 million have used in Central and Easter Europe where Sopharma has the rights to sell it. It is among the key original drugs of the company with Russia among its biggest markets.

Sopharma management optimistic about Russian and Ukrainian markets

The Company announced in a statement preliminary FY2016 sales slipped 5% y/y which is above our preliminary expectation. Domestic sales decreased 2% y/y on price erosion despite volumes growth while exports decreased 5% y/y, considerably better than the start of the year.

Management added in the statement that over the last couple of months it sees stabilization signals in Russia which gives it a dose of security for 2017. It is also optimistic on the positive sales trend in Ukraine as well as on the upward trend in Poland, Belarus and Latvia. CEO and major shareholder Ognyan Donev added in the statement that new drug registration including for the OTC Tuspan syrup to add to the positive trend in 2017.

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