SOURCE: BioVie Inc.

BioVie Inc.

July 26, 2017 08:00 ET

BioVie Files Patent Application in Japan for BIV201 for the Treatment of Ascites Due to Liver Cirrhosis

BEVERLY, MA--(Marketwired - July 26, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today the filing of an application in Japan for patent coverage of the Company's new drug candidate BIV201 for the treatment of ascites in patients with advanced liver cirrhosis. This follows the recent issuance of US Patent No. 9,655,945 for the use of BIV201 to treat this medical condition. The Company is pursuing an approach known as the "patent prosecution highway" in order to seek an expedited patent approval in Japan, which may take less than one year.

BioVie is an emerging leader in the development of drug therapies for ascites and other life-threatening complications of advanced liver cirrhosis. The Company is about to begin a mid-stage (Phase 2a) clinical trial in the US administering BIV201 to patients with 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.

Several US liver disease specialists have expressed interest in having access to terlipressin. This vasoconstrictive agent is known globally, and many Japanese physicians may also desire access for their chronic liver disease patients. A future Japanese patent approval could provide a strong business rationale for conducting a clinical development program in Japan in partnership with a Japanese pharmaceutical company, because the unmet medical need is substantial.

The US Patent No. 9,655,945 assigned to BioVie may be viewed on the USPTO website. More information about the Company's planned Phase 2a clinical trial may be found at clinicaltrials.gov. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.

About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites.

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.

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. BioVie cannot guarantee the issuance of a patent in Japan nor the completion or success of its planned Phase 2a clinical trial.

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