Navigation Links
Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

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.

"Hepatitis 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.

The 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 meeting.

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 is believed to work by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells.

For additional information about simeprevir clinical studies, please visit

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 - including approximately 3.2 million people in the United States - 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 Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit

(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 Research & Development, LLC 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, or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Janssen Launches EXPLORER, Global Cardiovascular Research Program, Beginning with Five New Studies in Patients with Unmet Medical Needs
2. Janssen Pharmaceutica, NV, Funds New Global Mental Health Scholarships as Part of Its Healthy Minds Program
3. Janssen Neuroscientists and Colleagues Challenge Healthcare Industry to Create Integrated Approaches to Healthcare Innovation in Newly Published Article
4. Janssen Labs at San Diego Expands to Add Concept Lab and Open Collaboration Space to Accommodate Individual Entrepreneurs and Additional Life Science Start-Ups
5. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
6. Janssen Research & Development Announces Establishment of Global Cross-Pharmaceutical Clinical Trial Investigator Databank
7. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
8. Janssen and Johnson & Johnson to Provide Webcast Presentation of Immunology Pivotal Phase 3 Data Being Presented at the American College of Rheumatology Annual Meeting
9. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
10. West Announces Agreement with Janssen Biotech to Develop and Commercialize a New Self-injection Technology
11. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
Post Your Comments:
(Date:11/26/2015)... November 26, 2015 3D bioprinting market ... according to a new report by Grand View Research Inc. ... (CKD) which demands kidney transplantation is expected to boost the ... substitute for organ transplantation. --> 3D bioprinting market ... according to a new report by Grand View Research Inc. ...
(Date:11/26/2015)... 26, 2015 ... "2016 Future Horizons and Growth Strategies ... Market: Supplier Shares, Country Segment Forecasts, Competitive ... offering. --> ) has ... Future Horizons and Growth Strategies in the ...
(Date:11/26/2015)... , November 26, 2015 ... --> adds "Global Repaglinide ... "Investigation Report on China Repaglinide Market, ... forecasts data and information to its ... . --> ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... ... EST until 11:59 p.m. EST, customers will be racing the clock to ... or more to free gifts with purchases, there will be a new sale available on ... skin care and cosmetic needs, customers will save on already discounted prices. , Top brands ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article published ... Toronto and the University of British Columbia suggested that laws requiring bicyclists to wear ... explains that part of the reason for the controversial conclusion is that, while helmets ...
(Date:11/27/2015)... PA (PRWEB) , ... November 27, 2015 , ... ... be a safe and convenient way to dispense prescription medications at home, so ... and effective way to monitor and dispense prescription medications. In doing so, it ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... ... use in Final Cut Pro X. With ProSidebar: Fasion, video editors can easily ... use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop zones, ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television ... an interesting show that delves into an array of issues that are presently affecting ... benefit from open dialogue, this show is changing the subjects consumers focus on, one ...
Breaking Medicine News(10 mins):