SOURCE: BioVie Inc.

September 09, 2016 10:06 ET

BioVie's Lead Compound BIV201 Receives FDA Orphan-Drug Designation for the Treatment of Ascites

BEVERLY, MA--(Marketwired - September 09, 2016) - BioVie Inc. (OTC PINK: BIVI) (the "Company"), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today that the Food and Drug Administration's Office of Orphan Products Development has granted orphan-drug designation for BIV201 for the treatment of ascites due to all etiologies except cancer. BIV201 is the Company's new drug candidate being developed for ascites due to chronic liver cirrhosis.

"Orphan-drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy. It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients," commented Jonathan Adams, BioVie CEO. "Additionally, it can help to accelerate our clinical development program, opens the door to special funding opportunities and tax credits, and could provide seven years of market exclusivity."

BioVie's clinical development team, comprised of five highly experienced pharmaceutical industry veterans and advised by worldwide leaders in liver disease, is currently focused on completing an investigational new drug (IND) application for BIV201. If accepted by the FDA, our new drug candidate could commence a US clinical trial in 2017. Once this goal is accomplished, BioVie will begin to explore other potential applications for BIV201 therapy. The active ingredient in BIV201 is a potent vasoconstrictor and this mechanism of action yields the potential to treat an array of life-threatening diseases, including type 1 hepatorenal syndrome (HRS), esophageal variceal bleeds, and sepsis.

For more information, 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 fatty liver disease linked to 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 US clinical trials as early as 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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