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BioVie Announces Patent Issuance Covering Ascites Treatment with BIV201
CARSON CITY, Nev., June 23, 2022 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug
About this update from Biovie Inc.
[{"type":"text","content":"CARSON CITY, Nev., June 23, 2022 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (\"BioVie\" or \"Company\"), a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that a patent covering the use of terlipressin monotherapy to treat ascites patients who have not progressed to hepatorenal syndrome (“HRS”) has been issued by the U.S. Patent & Trademark Office. This action restores U.S. patent protection for BIV201 (continuous infusion terlipressin), which had previously been lost due to an Inter Partes Review (“IPR”) challenge to a related patent by another company. “This newly-issued method of use patent, achieved through a continuation filing relating to our 2015 patent application, is expected to cover treatment with BIV201 in the U.S. until 2036. We are also pursuing overseas patent issuances,” said Cuong Do, chief executive officer of BioVie. “This new patent, together with our U.S. Orphan drug designation, global patent applications covering our novel liquid formulation, and a new patent application that the Company has not yet disclosed, is expected to provide critical long-term intellectual property protection.” Ascites may occur when severe liver disease progresses to cirrhosis and the liver fails, leading to the accumulation of excessive fluid in the abdomen. Since no therapies are approved to treat ascites in the U.S., clinicians may resort to the off-label use of diuretic drugs. Although some patients may show a response, many become intolerant to or unresponsive to diuretics over time – developing a condition called refractory ascites. Refractory ascites affects 20,000 patients in the U.S. each year. When medications are ineffective patients suffering from refractory ascites may be forced to have their excessive abdominal fluid physically removed by a large bore needle guided through the skin into the abdomen in a procedure called paracentesis. While paracentesis may provide patients with some symptomatic relief, fluid cyclically reaccumulates since there is no change to underlying liver disease pathology. Consequently, patients often need to repeat paracentesis on a weekly to monthly basis to remove multiple liters of fluid each time. As the ascites condition worsens, many patients progress to develop m...