- Category: Experimental HCV Drugs
- Published on Friday, 11 October 2013 00:00
- Written by Janssen
Janssen Pharmaceuticalsannounced this week that it has purchased a Phase 2 hepatitis C virus (HCV) NS5A inhibitor candidate, GSK2336805,from GlaxoSmithKline. Janssen is also developing the promising HCV protease inhibitor simeprevir (formerly TMC435), which is currently awaiting approval in the U.S. and Europe.
Below is an edited excerpt from a Janssen press release describing the acquisition.
Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis C from GlaxoSmithKline
Titusville, N.J.-- October 8, 2013 /PRNewswire -- 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."
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.
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.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. and Janssen R&D Ireland are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
Janssen Pharmaceuticals. Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis C from GlaxoSmithKline. Press release. October 8, 2013.