BioVie Granted Japan Patent for Terlipressin Liquid Formulation

BioVie Inc., a clinical-stage company known for developing innovative drug therapies for neurological and neurodegenerative disorders and advanced liver disease, announced a significant milestone. The Japan Patent Office has issued a Notice of Allowance for BioVie’s patent application concerning a novel liquid formulation of terlipressin, patent application number 2021-569344. This notice is expected to culminate in the issuance of a Japanese patent within the next two to three weeks following the completion of administrative procedures.

The patent's allowed claims encompass a unique liquid formulation of terlipressin acetate, exhibiting stability at room temperature for up to two years and can be packaged in a pre-filled syringe. This intellectual property fortifies BioVie’s efforts to develop a more patient-friendly ambulatory treatment plan for individuals suffering from ascites and hepatic failure in the United States.

Terlipressin is extensively used in over 40 countries for treating liver cirrhosis complications. Recently, it gained U.S. approval in the form of a lyophilized powder for in-hospital application, which necessitates reconstitution with sterile sodium chloride and refrigeration. BioVie’s innovative liquid formulation, however, remains stable at room temperature for 24 months, which is a considerable advantage for home-care administration.

Cirrhosis and ascites are severe conditions, with the latter involving the accumulation of large volumes of fluid in the abdomen due to liver and kidney dysfunction. Patients suffering from refractory ascites have a one-year survival rate of approximately 50%. Currently, there is no approved medical therapy exclusively for refractory ascites. The standard management involves procedures such as large-volume paracentesis and Transjugular Intrahepatic Portosystemic Shunt (TIPS), which offer temporary relief but often lead to severe complications and do not alter the disease's progression.

Cuong Do, President and CEO of BioVie, highlighted the significance of this development stating, "Our liquid formulation of terlipressin, which remains stable at room temperature for up to two years, offers a crucial benefit for treating cirrhosis and ascites patients, especially in home-care settings. The pre-filled syringe format enhances dosing convenience and safety. The new patent significantly strengthens our intellectual property concerning BIV201 and increases the program's value."

In addition to the recent allowances in the U.S. and Japan, BioVie has secured patents for its liquid formulation of terlipressin in India and Chile. The company has pending patents in several other markets including Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico, and Brazil.

Ascites, characterized by the excessive build-up of fluid in the abdomen, is a common and dangerous complication of advanced liver cirrhosis. The condition occurs due to the liver becoming congested and blood pooling in the splanchnic bed, reducing effective blood volume in the arteries. The body then attempts to correct this by retaining excessive amounts of water and salt, leading to ascites.

Advanced liver cirrhosis often stems from conditions such as NASH (non-alcoholic steatohepatitis), alcoholism, and Hepatitis B & C infections. Chronic liver disease, including cirrhosis, causes approximately 42,000 deaths annually in the U.S. Patients with liver cirrhosis and ascites frequently require hospitalization, resulting in an estimated $5 billion annual treatment cost.

BIV201, BioVie’s continuous infusion formulation of terlipressin, presents a new approach to managing ascites. It has potential benefits for reducing ascites by vasoconstricting blood vessels pooling blood, therefore restoring blood flow through the kidneys and liver, reducing portal vein pressure, and increasing arterial blood volume. This reduction may cause the body to shut down the RAAS system, which generates ascites.

BioVie Inc., listed on NASDAQ under BIVI, is at the forefront of developing drug therapies for neurological disorders such as Alzheimer's and Parkinson’s disease, as well as advanced liver disease. Their drug candidate, BIV201, has received Orphan Drug designation and Fast Track status from the FDA, making significant strides towards improving patient outcomes in liver disease treatment.