BioVie receives notice of allowance for U.S. patent covering liquid terlipressin

BioVie has received a Notice of Allowance from the United States Patent and Trademark Office for patent application no. 17/611,478 entitled “Formulations of Terlipressin.” This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed. The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US. Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications.