Patents covering BioVie's terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets

Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting

CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) 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 (often exceeding 5 liters) 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.