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Gilead Presents New Data Highlighting Progress in Liver Fibrosis

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Gilead Sciences, Inc. (NASDAQ:GILD) today announced data supporting the development of three investigational agents for the treatment of nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The data were presented in oral and poster sessions at The International Liver CongressTM 2016 in Barcelona, Spain.

NASH is a serious liver disease resulting from metabolic dysfunction that is associated with steatosis (fat within the liver), inflammation and fibrosis, which may progress to cirrhosis. NASH-related cirrhosis is expected to become the leading indication for liver transplantation by 2020. PSC is a disease characterized by inflammation and stricturing of the bile ducts. PSC can eventually lead to cirrhosis and other complications, including bile duct cancer.

“The data presented enhance our understanding of the pathogenesis of NASH and PSC – two progressive liver diseases for which there are no approved treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are committed to advancing the treatment of NASH and PSC by targeting multiple core pathways associated with metabolic dysfunction, inflammation and fibrosis. We are encouraged by the data presented at EASL and look forward to applying the scientific insights from these and other ongoing studies to enhance our clinical programs.”

Simtuzumab

Simtuzumab is a monoclonal antibody that is selective for lysyl oxidase-like-2 (LOXL2), an extracellular matrix enzyme that promotes fibrosis via the cross-linkage of collagen fibers. Gilead is evaluating simtuzumab for the treatment of fibrosis in patients with NASH and PSC in three ongoing Phase 2b clinical trials.

Data evaluating the associations between clinical features, liver histology and portal pressure at baseline in patients with NASH and PSC were presented in multiple poster sessions (Poster THU-016, Poster THU-369, Poster FRI-324, Poster FRI-350, Poster FRI-375 and Poster SAT-400). The data support the correlations between PSC-related liver fibrosis assessed histologically and noninvasive markers (e.g., serum levels of LOXL2 and liver stiffness by transient elastography).

An additional study presented during an oral session identified novel genetic polymorphisms associated with liver fibrosis and serum levels of LOXL2 in patients with PSC, which may help identify patients with an increased risk of disease progression (Oral PS-093).

These studies were led by Christopher Bowlus, MD, University of California, Davis, Sacramento, California (FRI-375); Zachary Goodman, MD, PhD, Inova Fairfax Hospital, Falls Church, Virginia (SAT-400); Andrew Muir, MD, Duke Clinical Research Institute, Durham, North Carolina (FRI-350); Arun Sanyal, MD, Virginia Commonwealth University, Richmond, Virginia (THU-016); and Patrick Shea, PhD, Institute for Genomic Medicine at Columbia University, New York, New York (THU-369; FRI-324; Oral PS-093).

Topline safety and efficacy data from the Phase 2b studies of simtuzumab for the treatment of NASH and PSC are anticipated by the end of 2016.

GS-4997

GS-4997 is a small-molecule inhibitor of apoptosis signal-regulating kinase 1 (ASK1), which promotes inflammation, apoptosis and fibrosis in settings of increased oxidative stress associated with NASH pathogenesis. GS-4997 is currently being evaluated in an ongoing Phase 2 study in patients with NASH and moderate to severe liver fibrosis.

Results from a Gilead-led preclinical study presented during an oral session (Oral PS-070) demonstrate that GS-444217, a related ASK1 inhibitor, significantly reduced hepatic steatosis, inflammation, fibrosis, serum cholesterol and insulin resistance in mice fed a diet high in fat, cholesterol and sugar. In addition, ASK1 inhibition led to significant changes in plasma metabolites related to bile acid and lipid metabolism.

GS-9674

GS-9674 is a selective, non-steroidal agonist of the Farnesoid X receptor (FXR), a nuclear hormone receptor that is highly expressed in the gastrointestinal tract and liver. FXR is the primary regulator of bile acid synthesis and plays important roles in glucose and lipid metabolism. Results from two preclinical studies selected for oral presentation highlight the therapeutic efficacy of GS-9674 in animal models of NASH. In a Gilead-led study, a diet-induced obesity model demonstrated that mice administered GS-9674 had reduced hepatic steatosis and fibrosis, as well as serum levels of cholesterol, ALT and AST compared with untreated animals (Oral PS-066).

In a second study, presented by Philipp Schwabl, MD, and led by Michael Trauner, MD, both of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, rats were administered sodium nitrate and fed a choline-deficient, high-fat diet for 10 weeks that resulted in cirrhosis and portal hypertension. Data demonstrate that GS-9674 treatment had dose-dependent anti-fibrotic effects and lowered portal pressure (Oral PS-058). The results of these pre-clinical studies support the evaluation of GS-9674 in patients with NASH following completion of an ongoing Phase 1 study.

Acetyl-CoA Carboxylase (ACC) Inhibitor NDI-010976

As announced on April 4, Gilead entered into an agreement to acquire the Acetyl-CoA Carboxylase (ACC) inhibitor program from Nimbus Therapeutics, which includes the clinical compound NDI-010976 and a number of other preclinical ACC inhibitors for the potential treatment of NASH, hepatocellular carcinoma (HCC) and other diseases. The acquisition is subject to certain closing conditions, including receipt of U.S. antitrust approval. Nimbus presented Phase 1 data (Oral PS-108) showing that NDI-010976 inhibited de novo lipogenesis in a dose-dependent fashion.

Further information about the clinical studies described above can be found at www.clinicaltrials.gov.

Simtuzumab, GS-4997, GS-9674 and NDI-010976 are investigational products and have not been determined to be safe or efficacious.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Gilead may observe unfavorable results from additional clinical trials involving simtuzumab, GS-4997, GS-9674 and NDI-010976 and Gilead’s acquisition of Nimbus’s ACC inhibitor program may not be completed since the transaction is subject to closing conditions. In addition, Gilead may make a strategic decision to discontinue development of simtuzumab, GS-4997, GS-9674 and NDI-010976 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000

Contact information

Gilead Sciences, Inc.
Investors
Patrick O’Brien, 650-522-1936
Media
Cara Miller, 650-522-1616

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