EB Pharma Announces License Agreement for Investigational Drug, Tipifarnib from Janssen Pharmaceutica for Development in Hepatitis Delta (HDV)

Food and Healthcare Press Releases Wednesday December 24, 2014 08:15
PALO ALTO, California--24 Dec--PRNewswire/InfoQuest

EB Pharma, LLC., a subsidiary of Eiger BioPharmaceuticals, Inc., today announced that it has executed an agreement with Janssen Pharmaceutica NV, ("Janssen"), for an exclusive license, to tipifarnib in the field of virology and a related, clinical stage back-up compound. EB Pharma is conducting clinical studies in patients infected with Hepatitis Delta (HDV) and will assess the efficacy and tolerability of tipifarnib as a potential new therapy.

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"This novel approach to treating HDV is the culmination of decades of research," said Jeffrey Glenn, MD, PhD, Scientific Founder and Associate Professor of Medicine, Stanford University. "I think it has the potential to change the treatment paradigm for the worst form of human viral hepatitis, and offers new hope for these patients."

"HDV is the least common but has the poorest outcome of all forms of viral hepatitis," said David Cory, President and Chief Executive Officer of Eiger. "We are excited to license tipifarnib from Janssen and study a potential new therapy for this life threatening disease."

About Tipifarnib

Tipifarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Tipifarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply. Since prenylation is a host process, not under control of HDV, and tipifarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with tipifarnib therapy. Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to tipifarnib resistance by HDV.

Tipifarnib is not approved for sale for any indication.
About HDV

Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people). Globally, HDV infection is reported to be present in approximately 4% - 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About EB Pharma

EB Pharma is a privately held subsidiary of Eiger BioPharmaceuticals, Inc., focused on the research, development and commercialization of innovative therapies in viral hepatitis. The company will focus on developing tipifarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis. Tipifarnib is not approved for sale. EB Pharma's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.

Investors: Jim Shaffer, Eiger Bio, Inc., +1-919-345-4256, jshaffer@eigerbio.com

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