Changing the Ascites Treatment Paradigm
BioVie Inc. (ticker symbol: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. Our new drug candidate, BIV201 (continuous infusion terlipressin), has completed a successful mid-stage (Phase 2a) clinical trial for treating ascites due to advanced liver cirrhosis. It has an Orphan Drug designation for the treatment of ascites, FDA Fast Track status, and pending US patents. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS).
BIV201 is a potential future treatment option for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial target for BIV201 therapy is refractory ascites, a very serious complication of liver cirrhosis with an estimated 50% mortality rate within 6 – 12 months.
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. The FDA has never approved a drug specifically for treating ascites. BioVie is targeting this landmark achievement.
BioVie’s management team consists of experienced executives who are used to getting results – together, we are focused on overcoming any obstacles and issues that might stand in the way of bringing needed treatment to those that suffer from ascites.
Mr. Peizer, the majority shareholder of BioVie, is an entrepreneur, investor, and financier with a particular interest in healthcare, having founded and successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a leader in behavioral and mental health management services. He has served as the Company’s Chairman of the Board of Directors and CEO since the Company’s inception in 2004. Mr. Peizer is the Founder, Chairman and CEO of NeurMedix, Inc., a biotechnology company with a focus on inflammatory, neurological and neuro-degenerative diseases. He is also the Chairman of Acuitas Group Holdings, LLC, his personal holding company that owns all of his portfolio company interests, including BioVie, NeurMedix and Catasys. Through Acuitas, Mr. Peizer also owns Crede Capital Group, LLC, an industry leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into portfolio companies. Mr. Peizer has a background in venture capital, investing, mergers and acquisitions, corporate finance, and previously held senior executive positions with the investment banking firms Goldman Sachs, First Boston, and Drexel Burnham Lambert. He received his B.S.E. in finance from The Wharton School of Finance and Commerce.
President & Chief Operating Officer
Jonathan Adams, MBA, who founded the predecessor company to BioVie in 2007, has over 30 years of biopharmaceutical industry experience. This includes finance, acquisitions and licensing, technology commercialization, global product launches, marketing and sales force management. At Searle Pharmaceuticals he was a member of the global launch team for Celebrex and performed key roles in product branding, market research, medical education, and other areas. Subsequently he worked in technology commercialization for next generation COX-2 inhibitors. After Searle, Mr. Adams worked in account management for healthcare advertising agencies and developed expertise in wide range of therapeutic areas while helping his clients to launch dozens of new drugs and devices. He then returned to industry to serve as a marketing leader for Mission Pharmacal’s urology division. Mr. Adams earned a BS at Cornell University and an MBA at the Tuck School at Dartmouth.
Penelope Markham, PhD
Chief Scientific Officer
Penelope Markham, PhD, led the development of modified terlipressin compounds for LAT Pharma LLC, the predecessor company to BioVie, for 7 years prior to its acquisition by BioVie. Previously, she spent 15 years in immunology, infectious disease, bacteriology and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx, Inc. engaged 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. Dr. Markham has more than 20 publications in peer-reviewed journals and three patents. She holds a BS in Biochemistry from the University College Cork, Ireland, an MS from Strathclyde University, Scotland, and a PhD from Rush University, Chicago.
Denise Smith, MS
Senior Vice President, Manufacturing & Development
Denise Smith, MS, has managed the development laboratory for a large CMO, where she was responsible for analytical development and validation, as well as the establishment of manufacturing processes for parenteral products (liquid, lyophilized, liposomes, emulsions) for new chemical entities for the National Cancer Institute and other contract customers. She also served as the CMO’s Associate Director of Validations. Since 2008, she has worked as an independent consultant in the pharmaceutical industry. She holds a BS in Microbiology from the University of Akron, and an MS in Biotechnology from Johns Hopkins University.
Wendy Kim, CPA
Chief Financial Officer
Wendy Kim, CPA, has over 25 years’ experience in accounting and finance. As a CFO prior to BioVie, she oversaw corporate finance and operational groups, closed 8 M&A transactions, secured bank financings, developed and implemented new business strategies, managed risk, and implemented new financial policies and procedures. As a public accountant with BDO USA LLP, she served for 8 years in the firm’s SEC Department and provided accounting, SEC filing reviews and other business consultative services to companies and engagement teams. Her areas of expertise include: Strategic and Financial Planning, Banking Relations and Fund Raising, Risk Management, Investor Relations, SEC Reporting/External Reporting Systems, Merger & Acquisitions, and Financial modeling/Forecasting. Ms. Kim earned her BBA in accounting & finance at California State University.
BioVie’s board of directors consists of highly accomplished executives in the life-sciences industry, many having built successful biopharma businesses.
Mr. Peizer, the majority shareholder of BioVie, is an entrepreneur, investor, and financier with a particular interest in healthcare, having founded and successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a leader in behavioral and mental health management services, having served as the Company’s Chairman of the Board of Directors and CEO since the Company’s inception in 2003. Mr. Peizer also is the Founder, Chairman and CEO and majority shareholder of NeurMedix, Inc., a biotechnology company with a focus on inflammatory, neurological and neuro-degenerative diseases. Mr. Peizer is Chairman of Acuitas Group Holdings, LLC, his personal holding company that owns his portfolio company interests. Through Acuitas, he owns Crede Capital Group, LLC, an industry leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into portfolio companies. Previously he was Chairman of Cray, Inc., the leading supercomputing company, and held senior executive positions at various publicly-traded growth companies and with the investment banking firms Goldman Sachs, First Boston, and Drexel Burnham Lambert. He received his B.S.E. in finance from The Wharton School of Finance and Commerce.
Steve Gorlin has founded many biotechnology and pharmaceutical companies over the past forty-five years, including Hycor Biomedical, Inc. (acquired by Agilent), Theragenics Corporation (NYSE: TGX) , Medicis Pharmaceutical Corporation (sold to Valeant for approximately $2.6 billion), EntreMed, Inc. (NASDAQ: ENMD), MRI Interventions (MRIC), DARA BioSciences, Inc. (NASDAQ: DARA), MiMedx (NASDAQ: MDXG), Medivation, Inc. (NASDAQ: MDVN), sold to Pfizer for $14 billion and Conkwest which became NantKwest (NASDAQ: NK). Mr. Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical Engineering Advisory Board. He also served on the Board of the Andrews Institute. He is currently a member of the Research Institute Advisory Committee (RIAC) of Massachusetts General Hospital. He started The Touch Foundation, a nonprofit organization for the blind and was a principal financial contributor to the founding of Camp Kudzu for diabetic children.
Bob Hariri, MD, PhD
Bob Hariri, MD, PhD, is the chairman, founder, and chief executive officer of Celularity, Inc., a leading human cellular therapeutics company. Dr. Hariri was the founder and CEO of Anthrogenesis Corporation, and after its acquisition by Celgene Corporation, served as CEO of Celgene Cellular Therapeutics. Dr. Hariri also co-founded the genomic-based health intelligence company, Human Longevity, Inc. He has served on numerous public boards including Cryoport (NASDAQ:CYRX). Dr. Hariri pioneered the use of stem cells to treat a range of life-threatening human diseases and continues to make transformative contributions in the fields of immuno-oncology and cell therapeutics. He is widely acknowledged for his discovery of pluripotent stem cells derived from the human placenta, and assisting with the discovery of the physiological activities of tumor necrosis factor (TNF). He holds over 170 issued and pending patents and has authored over 150 published chapters, articles, and abstracts. Over the years he has garnered numerous awards for contributions to the fields of biomedicine and aviation.
Sig Rogich is President of The Rogich Communications Group and serves on the Board of Keep Memory Alive, a philanthropic organization which raises awareness about brain disorders and Alzheimer’s disease. Keep Memory Alive funds clinical trials through Cleveland Clinic’s Lou Ruvo Center for Brain Health to advance new treatments for patients with Alzheimer’s, Huntington’s and Parkinson’s disease, as well as frontotemporal dementia and multiple sclerosis. Mr. Rogich was formerly the US Ambassador to Iceland. He has served as a senior consultant to candidates for the highest office, including Presidents Ronald Reagan and George H.W. Bush. Mr. Rogich serves on the Board of Directors for many charitable causes.
Cuong Do, MBA, is President, Samsung Global Strategy. 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. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years helping to 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, is currently CEO of Water Street Capital’s and JLL Partner’s Global Life Sciences Services Platform. He formerly served as the CEO of Decision Resources Group (DRG). 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 electrical and computer engineering from the University of New Hampshire, and an MBA from the Tuck School of Business at Dartmouth.
Michael Sherman JD recently retired from his position as a Managing Director at Barclays Plc, where he had worked since 2008. Previously he was a Managing Director at Lehman Brothers, Inc. He has worked in investment banking for 30 years. Mr. Sherman has significant experience in healthcare finance, most recently assisting on a $450 million convertible transaction for Neurocrine Biosciences. He has worked on successful financial transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck & Co., and Cardinal Health, among other companies. After graduating from the University of Pennsylvania, Michael Sherman received his JD, cum laude, from the Harvard Law School.
Richard J. Berman
BioVie’s medical advisors are worldwide leaders in the field of advanced liver cirrhosis. They are passionate professionals who have dedicated their lives and careers to improving the landscape of liver disease treatment.
Primary Medical Advisor
Paolo Angeli, MD, is Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University of Padova, Italy. He has participated in more than 15 clinical trials (Phase II – IV) in the treatment of clinical complications of portal hypertension and liver transplant. Currently he is Secretary of the International Ascites Club and, as a member of EASL, has participated in drafting guidelines for the management of patients with cirrhosis and ascites. Dr. Angeli has pioneered the use of continuous infusion terlipressin as a safer alternative to the traditional approach of intermitted IV bolus dosing in the treatment of hepatorenal syndrome. He is a frequent speaker on liver disease and has been widely published.