BioVie Receives Notice of Allowance for Japan Patent Application Covering Novel Liquid Formulation of Terlipressin

Core Viewpoint - BioVie Inc. has secured patents for its liquid formulation of terlipressin in multiple countries, which offers significant advantages for treating patients with cirrhosis and ascites, particularly in home-care settings [1][4][9]. Patent and Formulation - The company received a Notice of Allowance from the Japan Patent Office for its terlipressin formulation, expected to result in a patent issuance in 2 to 3 weeks [1]. - The allowed claims cover a novel liquid formulation of terlipressin acetate that is stable at room temperature for two years and can be packaged in a pre-filled syringe [2]. - BioVie has also received patent protection in India and Chile, with pending patents in Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico, and Brazil [4][9]. Clinical Context - Patients with cirrhosis and ascites often accumulate large volumes of fluid in the abdomen, leading to a one-year survival rate of approximately 50% for those with refractory ascites [3]. - Current management options for these patients are limited and primarily involve procedures that provide only temporary relief [3]. Drug Approval and Development - Terlipressin is already used in over 40 countries for treating complications of liver cirrhosis and has recently been approved in the U.S. as a lyophilized powder for in-hospital use [4][9]. - BioVie’s liquid formulation is designed for home-care settings, offering advantages such as room-temperature stability and improved dosing convenience [4][9]. Financial Implications - The treatment of patients with cirrhosis and ascites incurs an estimated $5 billion in annual costs in the U.S. [6]. - BioVie has secured Orphan Drug designation and Fast Track status for BIV201, which is being evaluated for the treatment of ascites due to liver cirrhosis [10].