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Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Date:7/22/2014

TEL AVIV, Israel, July 22, 2014 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, cleared Galmed's Investigational New Drug, or IND, application.  Such clearance will permit Galmed to conduct clinical trials of its product candidate, aramchol, in the United States for the treatment of fatty liver disorders. Galmed is initially developing aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.  According to scientific literature, NASH is a chronic disease that affects approxiately12% of the population in United States and in certain European Union nations and its prevalence is expected to increase in parallel with increased rates of obesity and diabetes. There are currently no approved drugs to treat NASH. 

In connection with the FDA's clearance of Galmed's IND application, Galmed submitted a request to the FDA for the approval of a Fast Track Designation for aramchol.  Fast Track Designation is a designation by the FDA that facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

"We believe that the IND application clearance serves as an additional validation for our development program and will allow us to perform clinical studies for our primary indication, NASH, as well as additional proof of concept studies of aramchol in the United States in the future," said Allen Baharaff, Galmed's Chief Executive Officer. "We further believe that the indications we are seeking
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SOURCE Galmed Pharmaceuticals Ltd.
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