SOURCE: BioVie Inc.

September 22, 2016 13:48 ET

BioVie Updates on Link Between NASH, Liver Cirrhosis, and Ascites

BEVERLY, MA--(Marketwired - September 22, 2016) - BioVie Inc. (OTC PINK: BIVI) (the "Company"), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced that its scientific team has completed an assessment of the link between nonalcoholic steatohepatitis (NASH), chronic liver cirrhosis, and ascites. The Company's new drug therapy BIV201 targets ascites, a common complication of liver cirrhosis.

The number of Americans afflicted with NASH due to fatty liver disease has skyrocketed to an estimated 16 to 30 million due to the obesity epidemic. With no FDA-approved therapy to halt progression of the disease, there is a significant unmet medical need for the estimated 1.3 million who will progress to advanced liver cirrhosis and its complications. According to a 2015 study by Wong et al., NASH is now the second-leading cause of liver disease among US adults awaiting liver transplantation, and is expected to become the leading cause within ten years. Additionally, patients with liver cirrhosis due to NASH, who are on the liver transplant waiting list, appear to have the lowest probability of survival compared to those having cirrhosis due to other causes.

Serious medical complications often occur in patients with advanced liver cirrhosis, the most common being the development of ascites, or fluid accumulation in the abdomen, a major contributor to patient mortality. BioVie is developing BIV201 as a new drug candidate for ascites due to liver cirrhosis as a result of NASH and other causes. Currently no drugs are available with a specific FDA approval for treating ascites.

BioVie CEO Jonathan Adams commented: "We are seeing impressive therapeutic advances in NASH, which is very gratifying. But it's important to keep in mind the many patients who progress to advanced liver cirrhosis and suffer miserably as a result. The progression of liver cirrhosis should be viewed as a continuum, and effective therapeutic interventions are needed at every stage."

For more information about BioVie and BIV201, please visit our website www.biovieinc.com.

About Liver Cirrhosis and Ascites

About one million 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 27,000 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 may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About BioVie (formerly NanoAntibiotics)
BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug ("pre-IND") meeting with the FDA, which provided guidance for an IND submission. The Company's new drug candidate could potentially commence a mid-stage (Phase 1b) US clinical trial in 2017.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie's compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie's filings with the SEC, other unknown or unpredictable factors also could affect BioVie's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

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