Janssen takes on GSK hep C drug
pharmafile | October 9, 2013 | News story | Research and Development, Sales and Marketing | GSK, GSK2336805, HCV, Janssen
Janssen Pharmaceuticals has acquired one of GlaxoSmithKline’s investigational hepatitis C treatments and will look at it in combination with various other drugs.
GSK2336805 is an NS5A replication complex inhibitor and, for an undisclosed sum, Janssen now possesses all rights to develop and commercialize the Phase II drug.
The company plans to start studies of it in interferon-free combinations with Janssen’s own investigational protease inhibitor simeprevir (TMC435) and TMC647055, its non-nucleoside polymerase inhibitor.
The idea is to evaluate the combinations in chronic hepatitis C in adults who also have compensated liver disease.
“We’re excited to add GSK2336805 to our existing portfolio of direct-acting antivirals,” said Gaston Picchio, Janssen’s hepatitis disease area leader. “This addition will broaden our clinical development programme as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus.”
Janssen and GSK agreed last year to conduct separate Phase II studies with Vertex Pharmaceuticals to test Vertex’s nucleotide analogue HCV polymerase inhibitor VX-135 with simeprevir and GSK2336805.
Producing all-oral treatments for hepatitis C would give manufacturers an edge over existing injectable interferon treatments, such as Roche’s Pegasys and Merck’s PegIntron.
The therapy area represents an exciting strand of study for pharma at present, with two new hepatitis C drugs, Janssen’s own Incivo (telaprevir) and MSD’s Victrelis (boceprevir), awarded the 2012 UK Prix Galien prize.
But there have been high profile failures too: Vertex abandoned development of its investigational adenosine nucleotide analogue ALS-2158, developed with Alios BioPharma, because of “insufficient antiviral activity to warrant proceeding”.
And Bristol-Myers Squibb admitted that the death of a patient was behind its decision to stop development of a potential treatment, the investigational nucleotide polymerase (NS5B) nucleotide BMS-986094.
Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
It was jointly developed by Janssen R&D Ireland and Medivir 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.
The drug is currently being studied in Phase II in combination with several direct-acting antivirals with different mechanisms of action, with and without ribavirin.
The COSMOS study combines it with Gilead’s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naïve genotype 1 hepatitis C patients, including those with cirrhosis, while another study is looking at it with Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir in the same patient group.
Meanwhile HELIX-1 combines simeprevir and Idenix’s once-daily pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naïve genotype 1b and genotype 4 hepatitis C patients.
Adam Hill
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