BioVie, Inc. To Benefit From Big Pharma Focus On NASH
An estimated 30 million Americans have NASH and approximately 1.5 million will go on to develop liver cirrhosis. NASH has become an exciting area for investment by large pharmaceutical companies.
BioVie, Inc. (BIVI) is a development-stage biopharmaceutical company targeting a major complication of liver cirrhosis called ascites. Ascites is the accumulation of fluid in the abdominal cavity and most often the result of liver cirrhosis brought on by a failing liver. Ascites affects approximately 100,000 individuals in the U.S. and results in 325,000 hospitalizations and 27,000 deaths each year. There is a direct link between ascites and the growing problem of non-alcoholic steatohepatitis (NASH) in the U.S. Companies such as Allergan plc (AGN), Gilead Sciences (GILD), Novartis AG (NVS), and Merck & Co. (MRK) are spending billions of dollars and conducting numerous clinical trials to find treatments for NASH patients. There are also a number of smaller competitors to BioVie’s NASH efforts with drugs participating in human studies. One of them is Conatus Pharmaceuticals (CNAT) that is developing its drug emricasan for patients with NASH fibrosis. Another is MediciNova (MNOV) which has had its drug fast tracked by the FDA for treatment for fibrotic liver diseases that include NASH, pulmonary fibrosis, and fatty liver disease. We direct our attention back to BioVie’s BIV201, which is a potent vasoconstrictor used outside the U.S. for the treatment of portal hypertension and other similar conditions to ascites. The drug has been granted orphan drug designation by the U.S. FDA. This will provide BioVie’s seven years of market exclusivity once approved. There is also a strong case that BIV201 will be awarded expedited approval in the U.S. should early clinical programs deliver positive results. BioVie plans to initiate a Phase 1b clinical study with BIV201 in the near future. Results from that trial are sure to attract attention from the aforementioned big pharma players looking to fill out their NASH pipelines with complementary products. #NASH #biotech $CNAT $BIVI
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