BEVERLY, Mass., March 07, 2018 (GLOBE NEWSWIRE) -- 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 submitted a response to questions raised by the Japanese Patent Office in regards to its application for patent coverage in Japan for its new drug candidate BIV201 (continuous infusion terlipressin). The Company also commented on the recent decline in its stock price.
“The questions raised by the Japanese Patent Examiner were generally similar to those we received from the US Patent and Trademark Office,” commented CEO Jonathan Adams, “and we have endeavored to answer them in a convincing manner.” The active agent in BIV201, terlipressin, is not commercially available in Japan. This country represents a significant market opportunity for BioVie with an estimated 400,000 liver cirrhosis patients.
Mr. Adams also commented on the recent decline in BioVie (ticker symbol: BIVI) stock price. “We are not aware of any reasons for the recent stock price decline. If there were any material changes we would have reported them. In the quarterly report ended December 31, 2017, we reported raising an additional $50,000 after the close of the quarter. This involved purchases of newly-issued BioVie common stock by directors at the price of 15 cents per share. We continue to pursue various funding opportunities, including strategic business combinations."
BioVie’s non-confidential company presentation was recently updated with assistance from our financial advisory firm. The new slide deck can be viewed on www.biovieinc.com, under the tab “Investors/Press Releases.”
The Company’s new drug candidate, BIV201, with Orphan-drug status, FDA Fast Track designation, and US patent protection, 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 the most common serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically indicated for the treatment of 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. BioVie has applied for additional Orphan-drug designations for other life-threatening conditions associated with advanced liver cirrhosis.
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 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.
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 Phase 2a clinical trial.