Full Press Release Details
Receives FDA Clearance of IND Application for
2a Clinical Trial in Refractory Ascites Patients
BioVie's Core Patent Covering
for Ascites Allowed by US
Conditions Satisfied to Commence
Funding Under the Aspire Capital
$12 Million Common Stock Purchase
MA - (Marketwired - April 3, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery,
development, and commercialization of innovative drug therapies for liver disease, is pleased to announce that it has received
notice from the US Food and Drug Administration (FDA) that the planned Phase 2a clinical trial of its new drug candidate BIV201
may be initiated. This was based on the Company's Investigational New Drug Application (IND) to conduct a study in patients
with refractory or intractable ascites due to advanced liver cirrhosis.
second key milestone was achieved when BioVie was notified by the US Patent and Trademark Office (USPTO) that its application for
a core patent covering the use of BIV201 to reduce ascites formation in ambulatory patients has been allowed. This application
was based on proprietary ascites patient data provided by the Company's medical advisor Paolo Angeli, MD, a leading global
expert in this field, and licensed from the University of Padova, Italy, where he practices medicine. The US patent is expected
to issue within 45 days at which time more details will be reported. The Company continues to pursue patent issuances in Japan,
China, and possibly European and other countries.
BioVie is pleased to announce that it has met all of the conditions needed to commence the previously announced $12 million common
stock purchase agreement with Aspire Capital Fund, LLC. Any funding received under the Aspire agreement will help to support the
start of the Phase 2a clinical trial mentioned above and be used for general corporate purposes.
represent three major advances for the Company and strongly support the BIV201 clinical development program" commented BioVie
CEO Jonathan Adams, "They're the culmination of many months of effort by our IND and management teams. We are excited
about taking the next steps as our compound enters the clinic. Although the primary focus will be on safety and pharmacokinetics,
we are also hoping to see signs of disease improvement in severely ill ascites patients."
Phase 2a clinical trial will consist of a small number of patients in an open-label study at a single US-based medical center,
and is expected to take about 8 months. Eligible patients will have cirrhosis with ascites requiring large-volume paracentesis
who are refractory to or unable to tolerate diuretic therapy. Pending the outcome of this first study, BioVie plans to follow with
a larger placebo-controlled Phase 2 study.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization
of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to
the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it
could initiate a Phase 2a US clinical trial. 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. It 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 drug specifically for treating ascites. For more information
about BioVie and BIV201, please visit our website: www.biovieinc.com.
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 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.
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 completion or success of its planned Phase 2a clinical trial.