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2014

Janssen Announces Data from Simeprevir in Hepatitis C Patients Will Be Presented at The International Liver Congress of the European Association for the Study of the Liver (EASL)

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CORK, Ireland, April 8, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of hepatitis C at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), which will take place April 24 to 28 in Amsterdam, The Netherlands. These data presentations will include primary efficacy and safety results from the Phase 3 QUEST-1 study of simeprevir administered once daily in combination with pegylated interferon and ribavirin in treatment-naive genotype 1 chronic hepatitis C patients.

"The presentation of this primary efficacy Phase 3 data in a peer-reviewed setting such as The International Liver Congress represents a significant milestone for simeprevir," said Maria Beumont, M.D., medical leader for simeprevir, Janssen. "These data show the potential utility of simeprevir for people living with hepatitis C."

Janssen recently announced the submission of new drug applications in Japan and the United States for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients and anticipates submitting simeprevir for regulatory authorization in the EU in the first half of 2013. Simeprevir is also being studied in combination with pegylated interferon and ribavirin for the treatment of genotype 4 HCV infection and in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.

Additional simeprevir data from the QUEST-2 study have been accepted by The International Liver Congress, but are subject to EASL's embargo policy until April 23. The data to be presented at The International Liver Congress 2013 include:

  • Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-1, a Phase III trial
    • Available Thursday, April 25Saturday, April 27
    • Lead Author: Ira Jacobson, chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical College, and attending physician, New York-Presbyterian Hospital/Weill Cornell Medical Center
  • Pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment
    • Available Friday, April 26
    • Lead Author: Sivi Ouwerkerk-Mahadevan, scientific director, Clinical Pharmacology, Janssen
  • Improved SVR with simeprevir (TMC435) associated with reduced time with patient-reported fatigue in treatment-naive, HCV-infected patients in the PILLAR Phase IIb trial
    • Available Friday, April 26
    • Lead Author: Jane Scott, director, Patient Reported Outcomes, Janssen
  • Adding simeprevir (TMC435) to pegylated interferon/ribavirin does not increase patient reported fatigue in treatment-experienced patients with chronic HCV infection: results from the ASPIRE trial
    • Available Friday, April 26
    • Lead Author: Jane Scott, director, Patient Reported Outcomes, Janssen
  • Combination therapy of TMC647055 with simeprevir (TMC435) in genotype 1 HCV patients
    • Lead Author: Stefan Bourgeois, gastroenterologist, ZNA Stuivenbergziekenhuis

Full session details and data presentation listings for The International Liver Congress 2013 can be found at http://www.easl.eu.

About Simeprevir
Simeprevir (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 works by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells. Janssen recently announced the submission of new drug applications for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in null-responder patients. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in treatment-naive and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients. To date, 1,846 patients have been treated with simeprevir in clinical trials.

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

  • Janssen's non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naive genotype 1a and 1b HCV patients; and
  • Gilead Sciences, Inc.'s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 HCV patients

In addition, Janssen has entered into a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a Phase 2 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. Janssen also has plans to initiate a Phase 2 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.

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

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, HCV can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which can include liver failure.

About Janssen R&D Ireland
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen R&D Ireland, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen R&D Ireland



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