The turf battle for the lucrative Hepatitis-C market is heating up, not only on the clinical front but also in the courts.
Idenix Pharmaceuticals, Inc. (IDIX), has filed two lawsuits against Gilead Sciences, Inc. (GILD): a patent infringement lawsuit in the United States District Court in Boston, Massachusetts, and a separate patent infringement and interference lawsuit in the United States District Court in Wilmington, Delaware.
The Massachusetts infringement lawsuit alleges that Gilead infringes two U.S. patents co-owned by Idenix (6,914,054 and 7,608,597) that cover methods of treating the hepatitis C virus using 2′-methyl nucleosides. The Delaware infringement and interference lawsuit alleges that Gilead infringes a separate U.S. patent co-owned by Idenix (7,608,600) that covers methods of treating the hepatitis C virus using 2′-methyl-2′-fluoro nucleosides.” In both cases, IDIX is seeking to prevent GILD from marketing its hepatitis-C treatment, sufosbuvir. Sufosbuvir is currently on file with the U.S. FDA and expected to be approved in early December
Separately, IDIX started enrollment for a phase 2 trial of an all-oral, interferon-free treatment for Hepatitis-C.
The trial is one of many being conducted on new interferon-free, all-oral treatments of Hepatitis-C including Gilead Science’s (GILD) sufosbuvir and AbbVie’s (ABBV) ABT-333. This new class of drugs is quickly stealing the limelight from older, interferon-based therapies, such as Vertex’s (VRTX) INCIVEK.
Hepatitis C, a chronic liver disease that affects about 150 million people worldwide, has proven difficult to treat because therapy is lengthy, expensive and unpleasant. In addition, many patients have other conditions that make treatment more complex and potentially dangerous.
The HELIX-2 trial is a 12-week, randomized, open-label study looking at the efficacy, safety and tolerability of IDIX’s samatasvir (IDX-719) in combination with simeprevir and TMC647055. Simprevir is a once-daily NS3/4A protease inhibitor jointly developed by Janssen – part of Johnson and Johnson (JNJ) and Medivir AB (MVIR). It received U.S. FDA approval to treat Hepatitis-C in October 2013. TMC647055, is a once-daily NS5B non-nucleoside polymerase inhibitor boosted with low-dose ritonavir developed by Janssen.
The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naive or who have relapsed after prior treatment with interferon and ribavirin. This is the same population studied in ABBV’s SAPPHIRE-I. We noted on, November 19, 2013 that ABBV Phase 3 trial results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients chronically infected with genotype 1 (GT1) hepatitis C virus (HCV) showed that 96% of patients saw their viral levels reduced at 12-weeks post treatment.
