Genfit could bring NASH liver disease treatment to market in 2019
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French biopharmaceutical company Genfit said on Monday it is to launch a phase 3 study of its treatment for liver disease 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 pct to 42.71 euros on the news.
There is currently no cure for Non-alcoholic Steatohepatitis (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.
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The American 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 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 authorized to put the product on the market.
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"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 authorization and commercial launch, to prepare marketing structures, especially alliances and collaborations to cover the whole of the global market."
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Mouney also confirmed that Genfit is "actively moving towards listing on the Nasdaq."