03/28/2013| Medivir AB announced that a new drug application (NDA) has been filed with the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir. The filing is based on phase III data in treatment-naïve and treatment-experienced patients with compensated liver disease.
The filing of a regulatory application in the US triggers a milestone payment of ?10m to Medivir.
Simeprevir is jointly developed by Medivir and Janssen Pharmaceuticals, Inc. (Janssen), and is 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.
“The filing in the U.S. is a very important milestone for simeprevir, the hepatitis C patients and for Medivir as a company. In addition it triggers a ? 10m milestone payment to us, which strengthens our solid financial situation even more.” comments Maris Hartmanis, CEO of Medivir.
The regulatory submission for simeprevir is supported in part by data from three pivotal phase III 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 III studies will be presented at different upcoming medical meetings.
Simeprevir, an investigational next generation NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, is currently in late phase III studies as a once-daily capsule (150 mg) taken in combination with pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 HCV.
Global phase III 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 null-responder patients. In parallel to these trials, phase III studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and Japanese HCV genotype 1 patients. Janssen recently announced the submission of a new drug application for simeprevir in Japan for the treatment of genotype 1 hepatitis C.
Simeprevir is being studied in phase II interferon-free trials with and without ribavirin in combination with:
- Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients;
- Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naïve and previous null-responder genotype 1 HCV patients; and
- Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir (BMS-790052) in treatment-naive and previous null-responder genotype 1 HCV patients.
In addition, Janssen has a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a phase II study the safety and efficacy of an all-oral regimen of simeprevir and Vertex’s investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen Pharmaceutical Inc. will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135.
We also recently announced plans to initiate a phase II trial of an investigational interferon-free regimen with simeprevir, TMC647055 and Idenix’s IDX719, a once-daily, pan-genotypic NS5A inhibitor, with and without ribavirin.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C worldwide, and 350,000 people per year die from the disease.
About Medivir AB
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland.
Simeprevir (formerly TMC435) is an experimental drug candidate for the treatment of hepatitis C. It is being developed by Medivir and Johnson & Johnson’s pharmaceutical division Janssen Pharmaceutica and is currently in Phase III clinical trials.
Simeprevir is a hepatitis C virus protease inhibitor.
Simeprevir is being tested in combination regimens with pegylated interferon alfa-2a and ribavirin, and in interferon-free regimens with other direct-acting antiviral agents including daclatasvir and sofosbuvir 
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- “Phase 3 Studies Show Simeprevir plus Interferon/Ribavirin Cures Most Patients in 24 Weeks”. hivandhepatitis.com. December 27, 2012.
- Medivir announces TMC435 in an expanded clinical collaboration. Medivir. 18 April 2012.
- [http://www.medivir.se/v4/en/ir_media/pressrelease.cfm Results from a phase IIa study evaluating Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients have been presented at CROI. 6 March 2013.