BEVERLY, Mass., April 09, 2018 -- BioVie Inc. (OTCQB:BIVI), a clinical-stage company focused on the development and commercialization of innovative drug therapies for liver disease, announced today that it has achieved 50% enrollment of the patients in its open-label Phase 2a clinical study of BIV201 (continuous infusion terlipressin) for treating refractory ascites due to advanced liver cirrhosis.
Penny Markham, PhD, BioVie Chief Scientist, stated, “The patients we are targeting for BIV201 therapy are desperately ill and experience a miserable quality of life. Absent liver transplantation, their outcomes are very poor. We are pleased to be working on developing a novel drug candidate that could potentially improve their future.”
BioVie is conducting a mid-stage (Phase 2a) clinical trial of its Orphan Drug candidate, BIV201 (continuous infusion terlipressin), which has FDA Fast Track status and US patent protection. This compound represents a potential new 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 a serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for treating 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.
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 more than 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 the treatment of ascites, an estimated 40% of patients die within two years of initial 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 medical 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 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. A company overview is available in Investors/Press Releases.
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 approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.
CONTACT INFORMATION
Josh Berg
Berg Capital Markets, LLC
[email protected]


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