BioVie’s New Drug Candidate BIV201 Receives FDA Orphan Drug Designation for the Treatment of Hepatorenal Syndrome (HRS) November 28, 2018 LOS ANGELES, CA / ACCESSWIRE / November 28, 2018 / BioVie Inc. (OTCQB: BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for liver disease, announced today that the US Food and Drug Administration (FDA) has granted an Orphan Drug designation to BioVie for terlipressin for the treatment of hepatorenal syndrome (HRS). BIV201 is a new drug candidate currently being tested in a mid-stage (Phase 2a) clinical study in patients with refractory ascites due to advanced liver cirrhosis. The Company previously secured an Orphan Drug designation for terlipressin for treating ascites, and is exploring additional Orphan designation opportunities."An estimated 12,000 to 33,000 Americans develop HRS each year," said BioVie CEO Terren Peizer. "Our novel drug candidate BIV201 could potentially become an [...]

BioVie Responds to Japan Patent Office and Comments on Recent Stock Price Decline March 8, 2018 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 [...]

BioVie Receives FDA Fast Track Designation for BIV201 for the Treatment of Refractory Ascites Due to Advanced Liver Cirrhosis December 11, 2018 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 [...]

BioVie Announces Second Patient Dosed with BIV201 in Phase 2a Clinical Trial; First Patient Completes 28-day Treatment Regimen November 8, 2017 BEVERLY, MA–(Marketwired – November 08, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, reported today that a second patient has been dosed with the Orphan drug candidate BIV201 (continuous infusion terlipressin) in a mid-stage Phase 2a clinical trial of patients suffering from refractory ascites due to advanced liver cirrhosis. This study is designed to evaluate a total of 6 patients with refractory ascites. Last month the first patient completed 28 days of treatment with BIV201 and entered the post-therapy observational period. “We are pleased with the progress and grateful to Dr. Jasmohan Bajaj, our Principal Investigator, and to the medical staff at the McGuire Research Institute for conducting the [...]

Accomplished BioPharma Executive Mina Sooch Joins BioVie Board of Directors and Purchases Company Stock November 2, 2017 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 [...]

Michael Sherman Joins BioVie Board of Directors and Purchases Company Stock October 25, 2017 BEVERLY, MA–(Marketwired – October 25, 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 Michael Sherman, a highly accomplished financial industry executive, to its Board of Directors as an independent director. In addition, Mr. Sherman purchased common shares of BioVie stock through a private placement. Mr. Sherman is currently on leave as a Managing Director at Barclays Plc, where he has worked since 2008. Prior to this position, Mr. Sherman was a Managing Director at Lehman Brothers, Inc. He has worked in finance for 30 years, having begun as a securities lawyer in New York and having served as an investment banker at Salomon Brothers, Lehman Brothers, and Barclays. Mr. Sherman has significant experience in [...]

BioVie Announces First Patient Dosed with BIV201 in Phase 2a Clinical Trial for Refractory Ascites due to Liver Cirrhosis September 28, 2017 BEVERLY, MA–(Marketwired – September 28, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, reported today that the first patient has been dosed with BIV201, which is being studied in a Phase 2a clinical trial for the treatment of refractory ascites due to liver cirrhosis. The initial trial will evaluate a total of 6 patients at the McGuire Research Institute in Richmond, VA.“We are excited to start this study and dose the first patient with our Orphan drug candidate BIV201 (continuous low-dose infusion terlipressin)” said Patrick Yeramian MD, Medical Director for BioVie. “There is a clear need for an effective drug therapy for patients with refractory ascites, as there are no [...]

Rich Wieland Joins BioVie Management Team as Chief Financial Officer September 25, 2017 BEVERLY, MA–(Marketwired – September 25, 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 the appointment of R. Richard Wieland II, MBA as the Company’s interim Chief Financial Officer. Mr. Wieland has served as the Chief Financial Officer (CFO) for multiple biopharmaceutical companies, including Lyphomed Inc., its acquirer Fujisawa USA (now Astellas Pharma US, Inc.), Advanced Life Sciences Holdings, Inc., which acquired certain clinical programs from Abbott, and Cytochroma Inc., which was developing drugs for chronic kidney disease before its acquisition by OPKO Health in Miami, Florida. He brings a strong track record of raising capital to BioVie, including over 20 private and public offerings totaling more than $800 million, and 11 merger and acquisition [...]