RARITAN, N.J., May 13, 2013 —
/PRNewswire/ — Janssen Research & Development, LLC (Janssen)
announced today that the U.S. Food and Drug Administration (FDA) has
granted Priority Review to the New Drug Application (NDA) for simeprevir
(TMC435), an investigational NS3/4A protease inhibitor administered as a
150 mg capsule once daily with pegylated interferon and ribavirin for
the treatment of genotype 1 chronic hepatitis C in adult patients with
compensated liver disease.
Simeprevir is a HCV NS3/NS4 protease inhibitor active against HCV
genotypes 1, 2, 4, 5, and 6. It is currently being tested in patients
with genotype 1 or 4 infection.
A second-generation HCV protease inhibitor, simeprevir (formerly
TMC435), cured around 80% of previously untreated people with genotype 1
hepatitis C infection when combined with pegylated interferon and
ribavirin, Michael Manns of the University of Hannover Medical School
reported last week at the EASL International Liver Congress (EASL 2013)
in Amsterdam. Overall, 91% of simeprevir-treated patients able to stop
all treatment after 24 weeks. [Produced in collaboration with Aidsmap.com]
— Filing Based on Phase 3 Data in Treatment-Naïve and Treatment-Experienced Patients with Compensated Liver Disease —
RARITAN, N.J., March 28, 2013
/PRNewswire/ — Janssen Research & Development, LLC (Janssen) today
announced it has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) seeking approval for simeprevir
(TMC435), an investigational NS3/4A protease inhibitor, administered as a
150 mg capsule once daily with pegylated interferon and ribavirin for
the treatment of genotype 1 chronic hepatitis C in adult patients.
C is a complicated disease and genotype 1 hepatitis C can be
particularly difficult to cure. Given the complexity and diversity of
the patient population, physicians need multiple options to provide
their patients a chance at treatment success,” said Wim Parys ,
Global Head of Development, Infectious Diseases and Vaccines, Janssen.
“The U.S. filing represents an important step forward in bringing
simeprevir to market and in helping to battle this challenging disease.”
Hepatitis C virus (HCV) is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the United States. When left untreated over time, HCV can cause significant damage to the liver, including cirrhosis.
regulatory submission for simeprevir is supported in part by data from
three pivotal Phase 3 studies: QUEST-1 and QUEST-2 in treatment-naïve
patients and PROMISE in patients who have relapsed after prior
interferon-based treatment. In each study, participants were treated
with one 150 mg simeprevir capsule once daily for 12 weeks plus
pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy
data from the Phase 3 studies will be presented at an upcoming medical
(TMC435) is an investigational NS3/4A protease inhibitor jointly
developed by Janssen and Medivir AB for the treatment of genotype 1
chronic hepatitis C in adult patients with compensated liver disease.
Simeprevir is believed to work by blocking the protease enzyme that
enables the hepatitis C virus to survive and replicate in host cells.
Direct-acting antiviral agents have brought
about a new era of treatment for chronic hepatitis C. While interferon-free
regimens are on the horizon, many patients have advancing liver disease and
cannot wait. Although HIV-positive people with hepatitis C experience more
rapid liver disease progression, they will have to wait longer for
interferon-free combos, as new agents are typically approved for HCV
mono-infected people first.
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that its
partner Janssen now has submitted a regulatory application to the
Japanese Ministry of Health & Welfare authorities seeking approval
for simeprevir, administered with pegylated interferon (Peg-IFN) and
ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C
patients who are treatment naïve, prior non responders or relapsed
following treatment with Peg-IFN with or without RBV. Simeprevir, an
investigational NS3/4A protease inhibitor, is administered as a single
once-daily pill for 12 weeks.
The regulatory submission in Japan
is supported by data from four Japanese phase III clinical studies of
once-daily simeprevir administered with Peg-IFN and RBV.
The filing of a regulatory application in Japan triggers a milestone payment of €5m to Medivir.
1.5 to 2 million people in Japan are infected with HCV. After infection
with HCV occurs, the infection persists in about 70 percent of cases,
leading to the onset of chronic hepatitis C. Continued inflammation can
cause liver fibrosis to progress into liver cirrhosis and liver cancer.1
In Japan, approximately 35,000 people die from liver cancer each year
and HCV has been found to be the cause in about 80 percent of cases.2
is a major event for simeprevir on its way to the different global
registrations. For us as an R&D driven company it is one of the most
exciting milestones that we have experienced”, comments Maris
Hartmanis, CEO of Medivir.
28 2013 – Medivir announced a collaboration between
Medivir/Janssen and Idenix for the clinical development of multiple HCV
inhibitors with and without ribavirin—all the studies will be
simeprevir (TMC435) is an HCV protease inhibitor is
currently in phase 3 studies—combined with pegylated interferon plus ribavirin—and
the combination is likely to be the next HCV therapy approved by the Food and
Drug Administration. Simeprevir (with
PEG/RBV) in phase 2 clinical studies was found to be more effective and have a
lower side effect profile than the currently approved HCV protease inhibitors.
is Medivir/Janssen’s polymerase inhibitor that is in early
clinical trials most notably in combination with simeprevir. In this trial TMC647055 will be boosted with
IDX719 is an NS5A inhibitor that has been shown in early
clinical trials to be pan-genotypic (works across multiple HCV genotypes). The addition of IDX would be beneficial for Jannsen’s
HCV development programs since their current DAA’s are being studied to treat HCV
genotype 1 and 4.
The first phase of the development collaboration
will be with simeprevir, ribavirin and IDX719 in HCV genotype 1 treatment-naïve
patients in the first quarter of 2013. Following
the completion and success of the first trial, a combination of the three DAA’s
(with and without ribavirin) will be initiated.
Janssen has multiple collaborations with other
pharmaceutical companies for various interferon-free studies:
combination with Gilead Sciences’ sofosbuvir (GS7977) in hepatitis C genotype 1
treatment-naïve or prior null responder patients.
combination with BMS’s, daclatasvir in hepatitis C genotype 1 treatment-naïve
or prior null responder patients.
combination with Janssen’s TMC647055 and low dose ritonavir in hepatitis C
genotype 1 treatment-naïve, prior relapser or null responder patients.
Simeprevir in combination with Vertex’s VX-135 in hepatitis C genotype 1
treatment-naïve patients to commence in 2013.
— Expanded clinical study program evaluating a combination of TMC435 and
— TMC435 and BMS-986094 (formerly INX-189), two direct-acting antivirals in
combination, will be evaluated in clinical trial
Medivir AB (OMX:MVIR)(STO:MVIRB), the research-based speciality pharmaceutical
company focused on the development of high-value treatments for infectious
diseases, announces that its development partner, Janssen R&D Ireland has
broadened its clinical collaboration agreement with Bristol-Myers Squibb Company
This announcement concerns an expansion of the clinical collaboration
agreement between Tibotec Pharmaceuticals (now Janssen R&D Ireland) and
Bristol-Myers Squibb (NYSE:BMY) announced by Bristol-Myers Squibb on 2nd
— Bristol-Myers Squibb and Janssen have agreed, pending the outcome of the
upcoming phase II study, to further study daclatasvir (BMS-790052) and TMC435 in
a phase III trial.