– Collaboration with ARUP Laboratories and Hepatitis B Foundation
– HDV viral load assay now available in U.S.
PALO ALTO, Calif., October 24, 2016, Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for rare diseases, today announced the launch of a nationwide hepatitis delta (HDV) campaign to expand patient access to testing and raise awareness of HDV co-infection in patients with hepatitis B virus (HBV) infection. Eiger is collaborating with ARUP Laboratories, Inc., a national clinical and anatomic pathology reference laboratory, and the Hepatitis B Foundation.
ARUP’s testing menu now contains the first-ever commercially available HDV RNA viral load assay in the U.S. Previously, HDV viral load testing was only available through the Centers for Disease Control and Prevention (CDC). The Hepatitis B Foundation just launched a comprehensive HDV educational website (www.hepDconnect.org).
“Eiger is committed to playing a leading role in developing novel treatments for HDV infection, the most severe form of hepatitis, and building awareness of the need for widespread testing,” said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Drug Development at Eiger. “The campaign represents an important step toward expanding and accelerating broad-scale HDV testing, and arming physicians and patients with information they need.”
“ARUP is a worldwide leader in innovative laboratory research and development,” said Edgar Braendle, MD, PhD, CEO and President of ARUP Laboratories. “ARUP’s hepatitis delta viral load assay is the first commercially available test in the United States to quantify the amount of HDV RNA in blood. This test allows clinicians to monitor the kinetics of HDV infections and adds to our broad suite of hepatitis tests. We are delighted to partner with Eiger and the Hepatitis B Foundation on this campaign, consistent with our mission to expand access to high quality healthcare and diagnostic services.”
“There is a tremendous lack of awareness among patients and providers about the serious problem of HDV co-infection, due in part to limited access to tests and the lack of therapies approved to treat HDV,” said Timothy Block, PhD, President and co-founder of the Hepatitis B Foundation. “Given recent advances in the availability of HDV viral load testing and an expanding pipeline of anti-HDV drug candidates, now is the time to launch an outreach campaign such as this. By increasing provider and patient awareness about HDV and the importance of testing for HDV to reduce the burden of disease, we will be able to make significant advances in eliminating the potentially lethal HDV coinfection among hepatitis B patients.”
The HDV viral load test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test.
About Hepatitis Delta Virus (HDV)
Hepatitis delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, liver failure, and higher risk of death and liver transplants. Hepatitis delta is a disease with a significant impact on global health, and due to migration, may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 5-6% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, Pacific Islands and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger BioPharmaceuticals, Inc.
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
About ARUP Laboratories, Inc.
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®.
About the Hepatitis B Foundation
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org, read the blog at hepb.org/blog, follow the Hepatitis B Foundation on Twitter@HepBFoundation and on Facebook at www.facebook.com/hepbfoundation or call 215-489-4900.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger’s future operations and drug development portfolio, Eiger’s ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the “Risk Factors” sections in the Annual Report on Form 10-K for the period ended December 31, 2015 and Eiger’s periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
SOURCE Eiger Bio, Inc.
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