BioVie Gets Patent Allowance for Novel Terlipressin Liquid Formulation

BioVie Inc., a clinical-stage company specializing in innovative drug therapies for neurological and liver diseases, has announced a significant milestone. The US Patent and Trademark Office has issued a Notice of Allowance for BioVie’s patent application no. 17/611,478 titled "Formulations of Terlipressin." This patent covers a novel liquid formulation of terlipressin acetate, which remains stable at room temperature for up to 24 months. This stability is a considerable advancement for the treatment of cirrhosis and ascites, especially in home-care settings, due to its ease of storage and use.

Currently, terlipressin is used in over 40 countries to treat complications associated with liver cirrhosis. Until recently, it was available in the US only as a lyophilized powder, which required reconstitution and refrigerated storage. The new liquid formulation, which can be packaged in pre-filled syringes, offers a more convenient and safer dosing option, particularly for home-care patients.

BioVie's President and CEO, Cuong Do, emphasized the importance of this innovation. He noted that the room-temperature stability of the liquid terlipressin formulation provides a significant advantage in treating cirrhosis and ascites in a home-care environment. The pre-filled syringe format also improves dosing convenience and safety, broadening the therapeutic potential of terlipressin.

Alongside the US, BioVie has secured patents for its liquid terlipressin formulation in India and Chile. Patents are pending in several other markets, including Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico, and Brazil. This global patent strategy enhances the intellectual property protection for BioVie's BIV201 program, which focuses on developing patient-centric treatments for liver diseases.

Ascites, characterized by excessive fluid accumulation in the abdomen, is a common and serious complication of advanced liver cirrhosis. Liver cirrhosis frequently results from conditions like non-alcoholic steatohepatitis (NASH), alcoholism, and Hepatitis B and C infections. The condition leads to significant morbidity and mortality, with an estimated 42,000 deaths annually in the US. Managing cirrhosis and ascites often involves repeated hospitalizations, contributing to substantial healthcare costs, estimated at $5 billion annually.

BIV201, BioVie's liquid terlipressin formulation, is a synthetic analogue of vasopressin and is designed for continuous infusion. It is intended to treat ascites by constricting blood vessels in the abdomen, thus improving blood flow through the kidneys and liver. This action reduces portal vein pressure and increases arterial blood volume, potentially decreasing the need for invasive procedures like large-volume paracentesis and TIPS, which provide only temporary relief.

BioVie has also secured Orphan Drug designation and Fast Track status from the US FDA for BIV201, specifically for the treatment of ascites due to liver cirrhosis. These designations may expedite the development and approval process, bringing this innovative therapy to market more quickly.

In addition to its work in liver disease, BioVie is developing treatments for neurological and neurodegenerative disorders. The company’s drug candidate bezisterim targets the inflammatory pathways involved in diseases like Alzheimer's and Parkinson's, aiming to reduce neuroinflammation and insulin resistance without impacting normal cellular functions.

BioVie continues to advance its pipeline of innovative therapies, driven by a commitment to addressing unmet medical needs in both liver disease and neurodegenerative conditions. The recent patent developments for its terlipressin formulation mark a significant step forward in the company's mission to improve patient outcomes and quality of life.

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