BEVERLY, MA--(Marketwired - February 22, 2017) - BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today that it has submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by BioVie last month.
"The FDA requested more information about the ambulatory pumps to be used in our clinical study. We have provided this information and conducted 3 bench studies, all with supportive results. Additionally, we incorporated the Agency's suggestions to improve the quality of our planned clinical study," commented CEO Jonathan Adams. "I also want to thank our talented IND team and research partners for their fast work in completing this response."
If notified by the FDA that the trial may proceed, BioVie plans to commence a mid-stage (Phase 1b) clinical trial of BIV201 in patients with refractory ascites due to advanced liver cirrhosis. BIV201 has the potential to become the first drug ever approved by the FDA specifically to treat ascites, a life-threatening medical condition. This innovative new drug candidate was granted Orphan Drug designation by the FDA last September.
About Liver Cirrhosis and Ascites
More than 600,000 American adults and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th leading cause of death in the US, killing an estimated 40,000 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 development-stage company pursuing the discovery, development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In November 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company's new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in the first half of 2017. 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. This new drug candidate 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 drugs specifically for treating ascites. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.
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 assure that the FDA will accept the BIV201 IND filing.