TICKER SYMBOL: BIVI
BioVie is pioneering an innovative technology that could yield the first drug ever approved in the US specifically to treat ascites due to liver cirrhosis.
Liver cirrhosis due to NASH, alcoholic liver disease and/or hepatitis is the 12th leading cause of death due to disease in the US, killing an estimated 27,000 people annually, and incurring treatment costs estimated at $4 billion annually. Ascites is liver cirrhosis’s most common complication and involves excessive accumulation of fluid in the abdomen, which can become life-threatening in patients with advanced liver cirrhosis. Patients with ascites suffer a miserable quality of life and frequent infections, as well as other complications requiring hospitalization that contribute to their decline.
Liver cirrhosis occurs when tissues inside the liver become damaged (“fibrotic”), which may be due to NASH (non-alcoholic steatohepatitis), alcoholism, hepatitis, or other causes. As the internal damage accumulates, the liver begins to “clog up” which impedes blood flow and its ability to clean and purify the blood. About 1 million Americans are afflicted with liver cirrhosis.
SEVERE LIVER CIRRHOSIS COMPLICATIONS
Once liver damage becomes very substantial, which may take up to 10 years or more, ascites and/or other serious complications may occur. Ascites is the most common complication, involving kidney dysfunction and the accumulation of substantial amounts of fluid in the abdominal cavity. This causes much patient suffering and sometimes leads to malnutrition. Ascites often causes other life-threatening complications such as infection, sepsis, and circulatory dysfunction.
CURRENT DRUG THERAPIES
Management Team: Jonathan Adams, MBA, Chief Executive Officer, founded LAT Pharma LLC and served as its CEO prior to its acquisition by BioVie. Mr. Adams has over 26 years of biopharmaceutical industry experience, including corporate finance, company acquisitions and licensing deals, marketing and sales support. At Searle Pharmaceuticals he was a member of the global launch team for Celebrex, and he has worked on launching numerous new drugs and medical devices. Mr. Adams earned a BS at Cornell University and an MBA at the Tuck School at Dartmouth. Amrit Shahzad, MBBS, MBA, President, has worked in the biopharmaceutical industry for more than 25 years. Prior to starting her own consulting firm in 2014, she worked in a variety of leadership roles at Roche, Amgen and Ikaria, and has been on the board of several startup companies. She has extensive business and corporate development experience including work at corporate venture funds. Her transactional experience spans multiple therapeutic areas, technologies, and platforms. Ms. Shahzad holds a medical degree (MBBS) from Lady Hardinge Medical College in New Delhi, India, and an MBA from Rutgers University. Penelope Markham, PhD, Chief Scientist, was a technical consultant to LAT Pharma LLC for 7 years prior to its acquisition by BioVie. She has spent 15 years in immunology, infectious disease, bacteriology and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx, Inc. Where she was involved in antibiotic drug discovery. She has been a member of NIH grant review panels and consulted for several pharmaceutical companies in a variety of therapeutic areas including orphan-drug development. She holds a BS in Biochemistry from the University College Cork, Ireland, a Masters from Strathclyde University, Scotland, and a PhD from Rush University, Chicago. Dr. Markham has more than 20 publications in peer-reviewed journals and three patents. Cuong Do, MBA, Director, is currently Executive Vice President, Global Strategy Group, at Samsung. Mr. Do helps to set the strategic direction for Samsung Group’s diverse business portfolio. He was previously the Chief Strategy Officer for Merck, a leading US pharmaceuticals company, Tyco Electronics, and Lenovo. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices. He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth. Jim Lang, MBA, Director, is currently a Senior Advisor at Decision Resources Group (DRG), and formerly served as DRG’s CEO. During his tenure he transformed DRG into a leading healthcare data and analytics firm. Previously Mr. Lang was CEO of Strategic Decision Group, a premier global strategy consultancy, where he expanded the life sciences practice and later sold it to IMS Health. He has invested in and guided the development of multiple early-stage healthcare companies including Boston Heart Diagnostics, which sold for $140 million, and AlphaImpactRx, which sold to IMS Health. He holds a BS from the University of New Hampshire, and an MBA from the Tuck School of Business at Dartmouth.
With no medications approved by the FDA specifically to treat ascites, the prognosis for these patients is very poor. Certain drugs which have been approved for other medical conditions (such as diuretics) combined with a salt restricted diet usually provide symptomatic relief in the initial stages of the disease. But as the ascites worsens their efficacy often diminishes. BioVie is working on a solution to address this critical unmet medical need.
Julie G. Anderson, Director. Anderson most recently served Catheter Connections, Inc. as its Vice President of Marketing until the company was sold last month. Previously she was Senior Director of Marketing for Durata Therapeutics, Inc., playing a key role in helping build the infrastructure and commercialization plan necessary to launch the novel antibiotic Dalvance. The team's efforts led to an acquisition of the company in 2014 by Actavis (now Allergan) in a deal valued at about $675 million. Prior to Durata, Julie worked for Sanofi-Synthelabo, Inc., Bayer Pharmaceuticals, and G.D. Searle in various marketing leadership positions. She originally trained as a nurse and earned a Masters of Management at the J.L. Kellogg Graduate School of Management at Northwestern University. As a critical care nurse, Julie treated patients at risk of death due to complications caused by chronic liver cirrhosis, and deeply understands the unmet medical need targeted by BioVie.
Hari Kumar, Director. Board of Directors as an independent director. In addition, Dr. Kumar purchased common shares of BioVie stock through a private placement. After earning a PhD in immunology in 1984, Dr. Kumar embarked upon a successful career in the biopharmaceutical industry. He held positions of increasing responsibility at Roche Pharma culminating in serving as Global Business Development Director, and in 2007 assumed the role of Chief Business Officer for Amira Pharmaceuticals. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million. He then served as Chief Executive Officer (CEO) for Panmira Pharmaceuticals LLC, which is developing anti-inflammatory compounds, and in 2013 became CEO for Adheron Therapeutics, which Roche Pharma acquired in 2015 for $580 million. Beyond his impressive track record, Dr. Kumar brings deep experience in fibrotic and liver diseases to the Company.
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