innovation

INNOVATION

sciencee

TECHNOLOGY

science

SCIENCE

doctor1

HEALTH

ABOUT

BioVie (OTC PINK: BIVI) is pioneering an innovative therapeutic approach targeting ascites due to liver cirrhosis. Ascites, or the accumulation of fluid in the abdomen, is the most common complication of cirrhosis due to NASH (non-alcoholic steatohepatitis), alcoholic liver disease and/or hepatitis C.  Ascites affects about 100,000 Americans and many times more worldwide, and contributes substantially to mortality. Our therapy BIV201 is based on a drug that is not yet available in the US but is approved in about 50 countries to treat related complications of liver cirrhosis.

The Company, formerly knows as NanoAntibiotics, Inc., recently acquired LAT Pharma LLC. This merger provided our lead development program, BIV201. Following a pre-investigational new drug meeting (“pre-IND”) with the FDA in early 2016, the Company is now assembling its IND package, and may commence a US clinical trial as early as 2017.

MANAGEMENT TEAM

MEDICAL ADVISORY BOARD

Guadalupe Garcia-Tsao, MD,

Guadalupe Garcia-Tsao, MD, is a Professor of Medicine in the Section of Digestive Diseases at Yale University School of Medicine and is the Chief of the Section of Digestive Diseases at the Veterans Administration-Connecticut Health Care System. Dr. Garcia-Tsao is a leading expert on ascites and other complications of liver cirrhosis and served as the President of the American Association for the Study of Liver Disease (“AASLD”) in 2012. As a member of the International Ascites Club she has contributed to recommendations on the management of ascites in cirrhosis. She has conducted multicenter studies in the complications of portal hypertension and cirrhosis including ascites, is a frequent speaker at the leading symposia for liver disease and has contributed to numerous publications.

Paolo Angeli, MD,

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.

Roberto Groszmann, MD,

Roberto Groszmann, MD, is Professor Emeritus of Medicine (Digestive Diseases) at Yale School of Medicine. He has spent 50 years in practice as a gastroenterologist with research focused on the core complication of liver cirrhosis, portal hypertension. Dr. Groszmann has led many clinical studies in liver cirrhosis and has authored or coauthored over 400 publications. His pioneering research and contributions to the understanding of liver hemodynamics and portal hypertension have been recognized with the Distinguished Achievement Award from the American Association for the Study of Liver Disease (“AASLD”) in 2002, the Distinguished Scientific Achievement Award from the American Liver Foundation in 2006, and the International Recognition Award from the European Association for the Study of the Liver (“EASL”) in 2016.

IND Team

Penelope Markham, PhD, Chief Scientist

Penelope Markham, PhD, Chief Scientist, was a technical consultant to LAT Pharma 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. 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, an MS 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.

Patrick Yeramian, MD

Patrick Yeramian, MD, brings three decades of experience in research and drug and medical device development to BioVie’s management team. He has served as a medical director for multiple organizations including Searle Pharmaceuticals (now Pfizer), the Vaccine and Gene Therapy Institute of Florida, and TapImmune Inc. During his career, he has helped companies secure over $25 million in grants and awards, filed more than 20 investigational new drug and device applications (IND/CTX/CTAs), and won regulatory approvals for five new drugs and devices. Dr. Yeramian received an MSc from University of Paris XI, an MD from Medical College of Paris XII, a DESS from University of Paris VII, and an MBA from Rutgers.

Stacy Suberg, PhD

Stacy Suberg, PhD,serves as BioVie’s regulatory expert. She founded Research-Based Regulatory, a consulting group focused on navigating the regulatory process for drugs and devices, and has served as its president for over 20 years. Prior to this Dr. Suberg worked as a research scientist at Bristol-Myers and as the director of North American Regulatory Affairs at Searle. Dr. Subergholds two patents and received a BS and BA at Southern Methodist University, a MS in Biology at the Illinois Institute of Technology, and a PhD in Physiology at the University of California Davis.

Denise Smith, MS

Denise Smith, MS, serves as a CMC consultant for BioVie. She 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.

Our toxicology expert

Our toxicology expert has over 50 years experience developing pharmaceuticals, is a past president of the American College of Toxicology and an author of over 40 articles, abstracts and book chapters.

CONSULTANT NETWORK

BioVie relies on a network of highly skilled and experienced independent consultants to support many of the projects associated with our drug development program. They include industry experts on preclinical studies, product supply and manufacturing, designing and conducting human clinical trials, FDA regulatory matters, and financial and legal experts.