BEVERLY, MA--(Marketwired - December 07, 2016) - BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Mr. James Lang as an independent member of the Company's Board of Directors. Mr. Lang is an active investor in emerging healthcare companies, and recently invested in BioVie.
Mr. Lang was formerly the Chief Executive Officer of Decision Resources Group (DRG), a leading healthcare research and consulting company. During his tenure there, Mr. Lang helped to transform the company into an industry leader, achieving robust revenue and profit growth. Previously Mr. Lang was the CEO of Strategic Decisions Group, a premier global strategy consultancy, where he expanded the life sciences practice and later sold it to IMS Health. He brings a highly relevant experience base, having invested in and guided the development of multiple early-stage healthcare companies including Boston Heart Diagnostics, which sold for $140 million, and AlphalmpactRx, which sold to IMS health earlier this year.
"Jim is an exceptionally talented businessman with a track record of building successful companies," said Jonathan Adams, BioVie CEO. "He is also enthusiastic about our new drug candidate BIV201, for which we recently submitted an IND application to begin clinical trials." Mr. Lang commented: "This is an exciting opportunity at this time, and the company is targeting an attractive and underserved space. I've known Jonathan and [BioVie board member] Cuong Do for many years, and I'm very confident in their capabilities."
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 to treat this condition.
BioVie submitted an Investigational New Drug (IND) application to the FDA for its lead therapeutic candidate BIV201 in November, 2016. The Company anticipates commencing a mid-stage (Phase 1b) clinical trial in US ascites patients in early 2017. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.
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 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 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 early 2017.
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.