BioVie: Launching Pivotal Phase 2b/3 Clinical Trial
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). 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 terlipressin. BioVie is targeting this landmark achievement.
BioVie: Near-Term Launch of Pivotal Phase 2b/3 Clinical Trial
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. Ascites patients incur more than $5 billion in annual treatment costs. No drugs are currently approved for treating refractory ascites.
With positive top-line results from its Phase 2a clinical trial of BIV201, completed in April 2019, BioVie is now preparing a much larger, multi-center, randomized and controlled pivotal Phase 2b/3 clinical trial. The trial is expected to take place at 15+ sites across the U.S., including Mayo Clinic, Mount Sinai, and Johns Hopkins. The trial protocol was submitted to the FDA in October 2019 and pre-meeting information package was submitted in February 2020 (response expected within 45 days of submission).
BioVie is led by a highly experienced and effective management team, including majority shareholder and Chairman and CEO Terren Peizer who has founded and successfully commercialized several healthcare companies. This team is complemented by an accomplished board that includes Cuong Do, President of Samsung Global Strategy Group and former Chief Strategy Officer at Merck; Jim Lang, CEO of Eversana; Michael Sherman, former managing director at Barclays and Lehman Brothers, and Richard Berman, former Chairman of National Investment Managers, a $12 billion pension administrator.
U.S. Market Revenue Potential
BioVie: Preparing Pivotal Phase 2b/3 Clinical Trial
BIV201 is a novel therapeutic approach to a severe unmet medical need
- Only late-stage drug candidate in development for refractory ascites (no drugs ever approved for treating refractory ascites)
- High cost of patient care creates strong economic rationale for drug therapy
- Planning to commence pivotal (Phase 2b/3) clinical trial in 2020
- Planning to submit NDA for US marketing approval in 2021
- Up to $500 million US ascites sales opportunity
- High profit margins anticipated
Robust intellectual property
- IP estate includes two Orphan drug designations
- Creating global patent estate to cover proprietary liquid terlipressin formulations
- Additional revenue opportunities for related conditions and global expansions
Experienced and effective management team
- Terren Peizer, Chairman & CEO; founded and successfully commercialized several healthcare companies. Chairman of Acuitas Group Holdings, a personal holding company that owns all of his portfolio company interests, $1.5B invested directly into portfolio companies; majority shareholder of BIVI
- Jonathan Adams, President & COO; 29 years of biopharma experience, including finance, M&A and licensing deals, technology commercialization, global product launches, drug marketing and sales force management
- Penelope Markhan, PhD, Chief Scientific Officer; 15 years of experience in immunology, infectious disease, bacteriology, and drug discovery research; 20+ publications in peer-reviewed journals and three patents