BEVERLY, MA--(Marketwired - September 28, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, reported today that the first patient has been dosed with BIV201, which is being studied in a Phase 2a clinical trial for the treatment of refractory ascites due to liver cirrhosis. The initial trial will evaluate a total of 6 patients at the McGuire Research Institute in Richmond, VA.

"We are excited to start this study and dose the first patient with our Orphan drug candidate BIV201 (continuous low-dose infusion terlipressin)" said Patrick Yeramian MD, Medical Director for BioVie. "There is a clear need for an effective drug therapy for patients with refractory ascites, as there are no FDA-approved drugs for this condition. These patients frequently develop life-threatening complications due to their disease and suffer from a poor quality of life. Our clinical objective is to improve their health status and reduce the need for hospitalizations."

The open-label, prospective, mid-stage (Phase 2a) clinical study is being conducted in patients who are refractory to, or intolerant of, diuretic therapy. It will take an estimated 6 to 9 months to complete. In addition to evaluating the safety of BIV201 therapy, the trial will examine indicators of potential efficacy, including the degree of ascites fluid generation and the need for paracentesis procedures (the withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite.

Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091)

About BIV201
BioVie Inc. began a mid-stage (Phase 2a) clinical trial with its lead candidate BIV201 in September 2017 at the McGuire Research Institute in Richmond, Virginia. This new drug candidate, which has Orphan-drug designation and US patent protection, represents a potential treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. The FDA has never approved any drug specifically for the treatment of ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis, but is not available in the US or Japan. BioVie has applied for additional Orphan-drug designations for life-threatening diseases associated with advanced liver cirrhosis.

About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies for liver disease. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. For more information about BioVie, please visit our website: www.biovieinc.com.

Forward-Looking Statements
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