BioVie NASDAQ:BIVI BioVie Inc. is developing BIV201 (continuous infusion terlipressin) an Orphan Drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use(s). It is being investigated as a potential new therapy for patients suffering from ascites, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications of advanced liver cirrhosis. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The Company has completed a Phase 2 clinical trial protocol that is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. 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 Company has invented a patent-pending prefilled syringe that has been cleared for use in our upcoming Phase 2 trial subject to certain additional standard analytical tests. This novel BIV201 delivery system is expected to greatly simplify at-home patient treatment and improve patient compliance by enabling easy injection of the liquid concentrate into the IV bag connected to the infusion pump. Room temperature stability has been achieved for 9 months providing an important advantage because, to the best of the Company's knowledge, all other terlipressin products sold globally must be stored under refrigeration. The novel prefilled syringe format also avoids the manual mixing of minute (2 - 4 mg) quantities of terlipressin powder in saline solution, thereby reducing the possibility of dosing errors during reconstitution and improving sterility. BioVie has begun applying for global patent protection for this novel terlipressin delivery system. The Company has also received Orphan Drug designation for the treatment of hepatorenal syndrome (HRS) and has FDA Fast Track status.

Location: | Website: www.biovieinc.com | Industry: Pharmaceutical Preparation Manufacturing | Sector: Manufacturing