SOURCE: BioVie Inc.

BioVie Inc (Ticker Symbol: BIVI)

November 02, 2017 07:00 ET

Accomplished BioPharma Executive Mina Sooch Joins BioVie Board of Directors and Purchases Company Stock

BEVERLY, MA--(Marketwired - November 02, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today welcomed Mina Sooch, a highly seasoned biopharma industry executive, to its Board of Directors as an independent director. In addition, Ms. Sooch purchased common shares of BioVie stock through a private placement.

Mina Sooch is a successful serial entrepreneur, executive, and angel/venture investor in the biotech and life sciences sector. From 2014 to 2017, she served as President, CEO, and Board member of Gemphire Therapeutics, a clinical stage cardiovascular company, advancing its oral drug candidate gemcabene (licensed from Pfizer) through multiple Phase 2b clinical trials and setting the foundation for a Phase 3 program as a potentially novel add-on treatment for addressing large cardiovascular and non-alcoholic steatohepatitis (NASH) market opportunities. Mina led multiple fundraising rounds totaling close to $60 million in private and public capital and took the company public (NASDAQ: GEMP) in August 2016. Prior to Gemphire, she co-founded and served as CEO of ProNAi, a Phase 2 clinical-stage oncology company, where she pioneered a novel nucleic-acid platform called DNAi, led the positive execution of Phase 1 and 2 trials for a first in class oncology drug candidate, advanced business development and partnering efforts, and raised over $70 million in financing from top-tier institutional investors, venture capital firms, and angel funds prior to the IPO.

Mina has been recognized as a business leader with awards such as "Dealmaker of the Year" in 2016 and 2014 by Crain's Detroit and "Entrepreneur of the Year" in 2015 by MVCA. Prior to her CEO roles, she spent over a decade in life sciences venture capital as a Founder of Apjohn Ventures with several portfolio companies developing drug/device treatments for kidney, liver, and inflammatory diseases. Earlier in her career she served as global account manager at Monitor Group, a top global strategy consulting firm where she worked on the multi-billion-dollar Pharmacia & Upjohn merger and co-led the launch of a Corporate Finance group specializing in M&A, valuations, and merger integration. Mina received an MBA from Harvard Business School and graduated summa cum laude from Wayne State University with a BS in Chemical Engineering.

"Mina is a biotech dynamo," said Jonathan Adams, CEO, "she very quickly understood BioVie's opportunities and business needs, and brings incredible energy and expertise to our strategic planning, financing strategy, and operational discussions for a company at our stage. We are very pleased to welcome her to the BioVie team and expect to benefit greatly from her input and advice as we build the foundation for a successful company."

Ms. Sooch commented, "I am excited to join this impressive biopharma-experienced Board and management team with a clear vision to pioneer new treatment options for patients with advanced liver disease. I am passionate about addressing the growing epidemic around the globe of late-stage liver disease and kidney failure and look forward to assisting BioVie with executing its near term clinical milestones."

BioVie is currently conducting a mid-stage (Phase 2a) clinical trial of the Orphan drug candidate BIV201 (continuous infusion terlipressin) for the treatment of refractory ascites. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US, and the FDA has never approved a drug specifically for the treatment of ascites.

About BioVie Inc.

BioVie Inc. (OTCQB: BIVI) is a clinical-stage company pursuing the discovery, 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.

About BIV201

BioVie Inc. began a Phase 2a clinical trial with its lead candidate BIV201 in September 2017 at the McGuire Research Institute in Richmond, Virginia. This new drug candidate, which has Orphan-drug designation and US patent protection, represents a potential treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. More information about the trial may be found at clinicaltrials.gov, identifier: NCT03107091.

The initial disease target for BIV201 therapy is ascites, which is the most common serious complication of advanced liver cirrhosis. 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 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.

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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