Biopharmaceutical company GENFIT reported that its leading drug candidate, GFT505, has received extension of patent protection from major worldwide pharmaceutical markets.

Following on from GFT505 patents already delivered in the United States, Europe, China, Russia, and Australia, the Canadian, Japanese, and Indian patent offices have granted new patents to GENFIT. All these new patents concern GFT505, as well as a series of structural variants, their synthesis procedures, and their pharmaceutical use in the field of cardiometabolic diseases, as well as their combination with existing medicines.

This patent cover also spans the use of GFT505 in certain hepatic complications of pre-diabetes and diabetes, including NASH, the major therapeutic indication for GFT505. This therapeutic position was recently strengthened by the GFT505-210-6 study of insulin-resistant patients, that met all its primary and secondary efficacy endpoints and demonstrated the safety of use of GFT505.

These new patents bring the total number of GENFIT’s international patents to 217, of which 152 cover GFT505.

Jean-François Mouney, chairman and chief executive officer of GENFIT, declared: “Over the years GENFIT has created an extensive patent cover for GFT505, comprising a wide range of clinical and pharmaceutical data of strategic importance for its future commercialization by a partner. In parallel, the company continues to pursue its activities in technological and clinical development, notably in the field of biomarkers. These developments will result in additional patent applications in 2012, and should further strengthen this strategical position”.
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NAFLD (non-alcoholic fatty liver disease) and in particular NASH (non-alcoholic steatohepatitis) are serious liver diseases that can lead to cirrhosis and liver cancer. The development of NAFLD/NASH is associated with the diabetic pathophysiological process. NAFLD is believed to affect between 80 and 100% of diabetic patients, and progresses to chronic liver disease (NASH) in 20-50% of cases. Mortality due to liver disease is thus 2-3-fold higher in the diabetic population than in the overall population. The NASH market was estimated at 615 $M in 2010 and should reach 2,008 $M in 2018.

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases).