Genfit could bring NASH liver disease treatment to market in 2019

Last Updated: 2015-11-16

By Reuters Staff

Paris (Reuters) - French biopharmaceutical company Genfit said on Monday it is to launch a phase 3 study of its treatment for non-alcoholic steatohepatitis (NASH) by year-end as part of an accelerated approval procedure which could allow it to be brought to market in 2019.

Genfit shares rose 5% to 42.71 euros on the news.

There is currently no cure for NASH, a degenerative liver disease caused by an excessively rich diet. The market for a NASH treatment is estimated at between $30 and $40 billion.

The U.S. Food and Drug Administration (FDA) gave Genfit's NASH drug elafibranor 'subpart H' status, which speeds up the approval process.

U.S.-based firm Intercept received the same status for its competing drug obeticholic acid (OCA), but released disappointing test results for it in October.

The first stage of Genfit's phase 3 study will last 18 months, after which it could be authorised to put the product on the market.

"It is reasonable to think that we will bring Elafibranor to market in 2019", chairman and chief executive of Genfit Jean-Francois Mouney told Reuters.

Mouney added that Genfit is in discussions with investors and partners to develop the company and that the phase 3 study - which should cost around 150 million euros - is part of these discussions.

"It is important, before the authorisation and commercial launch, to prepare marketing structures, especially alliances and collaborations to cover the whole of the global market."

Mouney also confirmed that Genfit is "actively moving towards listing on the Nasdaq."