Janssen acquires investigational NS5A inhibitor for the treatment of Hepatitis C from GlaxoSmithKline

Janssen Pharmaceuticals, Inc. (Janssen) announced today the acquisition of the investigational compound GSK2336805, an NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic hepatitis C, from an affiliate of GlaxoSmithKline plc. Janssen has acquired all rights to develop and commercialize GSK2336805, including in combination with other drugs. Financial details of the agreement have not been disclosed.

Janssen plans to initiate Phase 2 studies to evaluate the use of GSK2336805 in interferon-free combinations with the investigational protease inhibitor simeprevir (TMC435) and TMC647055, Janssen’s non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

“We’re excited to add GSK2336805 to our existing portfolio of direct-acting antivirals (DAAs). This addition will broaden our clinical development program as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus,” said Gaston Picchio, Hepatitis Disease Area Leader, Janssen. “Janssen is dedicated to working with the hepatitis C community to investigate our portfolio of DAAs in a number of different treatment combinations and hepatitis C patient populations.”

About GSK2336805

GSK2336805 is an investigational once-daily NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis.

About Simeprevir

Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except in the Nordic countries. Medivir will retain marketing rights for simeprevir in these countries. Simeprevir has been submitted for regulatory approval in the United States, Canada and Europe, and was approved in September 2013 in Japan. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

Additionally, simeprevir is being studied in combination with several DAAs with different mechanisms of action, with and without ribavirin, as part of interferon-free regimens. These include:

• The Phase 2 COSMOS study of simeprevir and Gilead’s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 hepatitis C patients, including patients with cirrhosis;
• A Phase 2 study of simeprevir and Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 hepatitis C patients; and
• The Phase 2 HELIX-1 study of simeprevir and Idenix’s once-daily pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naive genotype 1b and genotype 4 hepatitis C patients.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.