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Janssen Files First Regulatory Application for Simeprevir (TMC435) for the Treatment of Genotype 1 Hepatitis C Patients in Japan

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TOKYO (February 22, 2013) -- Janssen Pharmaceutical K.K. (Janssen) today announced it has submitted a regulatory application to Japanese health authorities seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, as well as patients who were non-responders to prior therapy or relapsed following treatment with pegylated interferon with or without ribavirin.

The regulatory submission in Japan is supported by data from four Japanese Phase 3 clinical studies of simeprevir administered with pegylated interferon and ribavirin.

Approximately 1.5 to 2 million people in Japan are infected with hepatitis C virus (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]

“There continues to be a need for simple and well-tolerated treatments for patients with genotype 1 HCV infection,” said Johan Van Hoof, Global Head, Infectious Diseases and Vaccines Therapeutic Area, Janssen Research & Development. “Janssen is committed to working with the HCV community, caregivers and healthcare systems to address this global epidemic and ultimately work towards a cure for all people living with HCV.”

About Simeprevir
Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland, an affiliate of Janssen, and Medivir AB to treat chronic hepatitis C patients. Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral agents with different mechanisms of action in all-oral interferon-free regimens, with and without ribavirin.

Japan’s Phase 3 clinical program for simeprevir consists of four studies in patients with genotype 1 HCV: CONCERTO-1 in treatment-naïve patients, CONCERTO-2 and -3 in prior non-responders or patients who relapsed after prior interferon-based treatment, and CONCERTO-4 using different pegylated interferon treatments in a broad patient population.

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 prior non- and partial responders. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and in Japanese HCV genotype 1 patients.

For additional information about simeprevir, please visit

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 HCV worldwide, and 350,000 people per year die from the disease. In Japan, the most prevalent HCV genotypes are 1b and 2; genotype 1b is more difficult to cure. Thanks to governmental measures in Japan implemented in the 1990s, such as the thorough inspection of blood for transfusions, prevention against new hepatitis C infections has proven effective. However, it is still estimated that 1.5 to 2 million people in Japan are infected with HCV.

About Janssen Pharmaceutical K.K.
Janssen Pharmaceutical dedicated to addressing and solving the most important unmet medical needs in oncology, immunology, CNS disorders, pain management, and infectious disease. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative products and services to solve health challenges and support patients around the world. Janssen Pharmaceutical K.K. is part of the Janssen Pharmaceutical Companies of Johnson and Johnson.

1) “May 2012 Treatment Guidelines of Hepatitis C” edited by The Committee for Hepatitis Clinical Guidelines, Japan Society of Hepatology
2) “Latest Statistics on Cancer (2010 Updated Version)” by the Center for Cancer Control and Information Services, National Cancer Center


(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 Pharmaceutical KK, any of the other Janssen Pharmaceutical Companiesand/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 or other intellectual property rights; 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. 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.)

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