Janssen announces collaboration with Vertex on phase 2 study

Janssen Pharmaceuticals, Inc. today announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen for the treatment of hepatitis C (HCV). The regimen will include Janssen’s investigational protease inhibitor simeprevir (TMC435) and Vertex’s investigational nucleotide analogue HCV polymerase inhibitor VX-135. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135. The DDI study will support the initiation of the Phase 2 study in early 2013 pending discussions with regulatory authorities.

The goal of the Phase 2 study will be to evaluate the safety, tolerability and viral cure rates of a 12-week regimen of simeprevir and VX-135, administered with and without ribavirin, in treatment naïve patients who have chronic non-cirrhotic genotype 1 HCV. The companies will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.

Simeprevir is an investigational NS3/4A protease inhibitor currently in Phase 3 trials, developed in collaboration with and licensed from Medivir AB. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of HCV by acting on the NS5B polymerase.

“There is a significant unmet need for all-oral treatment regimens for people living with hepatitis C,” said Wim Parys, Global Head of Infectious Diseases at Janssen. “Janssen’s collaboration with Vertex underscores our commitment to better understand the potential utility of simeprevir in a number of different IFN-free treatment combinations and HCV patient populations.”

About Simeprevir

Simeprevir (TMC435) is a NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic HCV infection. Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral agents in all-oral interferon-free regimens, with and without ribavirin.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naïve patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in treatment-experienced patients. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in both treatment-naïve and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in other Phase 2 interferon-free trials with and without ribavirin in combination with:

• Janssen’s TMC647055 and ritonavir in treatment-naïve, relapser or null-responder HCV genotype 1 patients;
• Gilead Sciences, Inc.’s sofosbuvir (GS-7977) in null-responder HCV genotype 1 patients; and
• Bristol-Myers Squibb’s daclatasvir (BMS052) in treatment-naïve or previous null-responder HCV genotype 1 patients.

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