SOURCE: BioVie Inc.

BioVie Inc (Ticker Symbol: BIVI)

December 11, 2017 07:00 ET

BioVie Receives FDA Fast Track Designation for BIV201 for the Treatment of Refractory Ascites Due to Advanced Liver Cirrhosis

BEVERLY, MA--(Marketwired - December 11, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the development and commercialization of innovative drug therapies for liver disease, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for BIV201 (continuous infusion terlipressin), the Company's patented Orphan drug candidate. BIV201 is currently being evaluated for the treatment of refractory ascites due to liver cirrhosis in a mid-stage (Phase 2a) US clinical trial, with 2 of the planned 6 patients having been treated with this therapy to date.

The FDA's Fast Track program is designed to facilitate development and expedite the review of drug candidates that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Fast Track designation allows for more frequent communications with the FDA to discuss the clinical development program and review process. Upon submission of a marketing application, drug candidates with Fast Track designation ordinarily qualify for priority review, thereby expediting the FDA review process.

"We appreciate the FDA's recognition of the importance of developing an effective therapy to treat ascites, and the medical potential for our new drug candidate, BIV201," commented Penny Markham, PhD, BioVie's Chief Scientist. "The prognosis for cirrhotic patients with refractory ascites is very poor, with an estimated mortality rate of 50% within 6 to 12 months, and they are prone to serious complications and hospitalizations associated with their disease. Their quality of life is miserable due to abdominal pain, difficulty in eating, breathing, and walking and other problems. There are no drug therapies approved by the FDA specifically for treating ascites, creating a serious unmet medical need."

BioVie has begun a mid-stage (Phase 2a) clinical trial with its Orphan drug candidate, BIV201, in ascites patients who are refractory to, or intolerant of, diuretic therapy. The trial will take an estimated 6 to 9 months to complete. In addition to evaluating the safety of BIV201 therapy, it will examine indicators of potential efficacy, including ascites fluid volume and the need for paracentesis procedures (the mechanical withdrawal of large amounts of ascites fluid by large bore needle). The study will also evaluate the steady-state pharmacokinetics (PK) of terlipressin and its active metabolite. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03107091). The safety and efficacy of BIV201 (continuous infusion terlipressin) as a treatment have not been established with the FDA.

About BIV201

The Company's new drug candidate, BIV201, has Orphan-drug designation and US patent protection, and 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 life-threatening diseases 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 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 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.

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 Phase 2a clinical trial.

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