BioVie Announces Issuance of US Patent Covering BIV201 for the Treatment of Ascites Due to Liver Cirrhosis
BEVERLY, MA–(Marketwired – May 24, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today announced that the US Patent and Trademark Office (USPTO) has issued US Patent No. 9,655,945 covering the Company’s new drug candidate BIV201 in development for the treatment of ascites in patients with advanced liver cirrhosis.
BioVie’s medical advisor Paolo Angeli, MD, and Company personnel pioneered this potential new therapeutic approach. The patent is supported by clinical data generated by Dr. Angeli and licensed exclusively to the Company by the University of Padova, Italy. It is assigned to BioVie and will provide patent exclusivity in the US under the issued claims through 2036.
“Dr. Angeli is deeply committed to improving medical therapy for these desperately ill patients and it has been our privilege to work with him,” commented Jonathan Adams, BioVie CEO. “This newly-issued patent provides strong intellectual property protection for our lead therapeutic candidate BIV201. It positions BioVie as the emerging leader in developing a new drug therapy for ascites and potentially other deadly complications of advanced liver cirrhosis.” BIV201 could become the first drug ever approved by the FDA for treating refractory ascites due to liver cirrhosis, a life-threatening condition which affects about 10,000 Americans.
BIV201, which has Orphan drug status, is a continuous infusion of the peptide terlipressin. It will soon commence a Phase 2a trial in 6 patients with liver cirrhosis and ascites who are refractory to, or intolerant of, diuretic therapy and require large-volume paracentesis (withdrawal of >4 liters of ascites fluid with a large-bore needle). Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from a similar disease pathway. Terlipressin is not available in the US and currently there are no drugs approved by the FDA specifically to treat ascites.
US Patent No. 9,655,945 may be viewed on the USPTO website. More information about the Company’s planned Phase 2a clinical trial may be found at clinicaltrials.gov. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing an estimated 40,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
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