Final Data from the Phase 2 COSMOS Study of Janssen’s Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress(TM) 2014 of the European Association for the Study of the Liver (EASL)

April 12, 2014

LONDON, April 12, 2014 /PRNewswire/ — Janssen R&D Ireland (Janssen) today announced new results from cohort 2 of the Phase 2 COSMOS study demonstrating that 93 percent of patients with the hepatitis C virus (HCV) and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir administered once daily with Gilead Sciences, Inc.’s sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks. The final data, along with an additional analysis from cohort 1 of COSMOS, were presented at The International Liver Congress(TM) 2014 of the European Association for the Study of the Liver (EASL) in London.


“The combination of simeprevir and sofosbuvir demonstrated efficacy, including in patients with more advanced liver fibrosis,” said Eric Lawitz, M.D., simeprevir clinical trial investigator, Medical Director at The Texas Liver Institute and Professor of Medicine at University of Texas Health Science Center. “I look forward to seeing the results of the recently announced Phase 3 OPTIMIST trials, which will further evaluate simeprevir and sofosbuvir without interferon or ribavirin.”

The COSMOS study examined the efficacy and safety of simeprevir and sofosbuvir in chronically-infected HCV genotype 1 patients who did not respond to prior therapy with pegylated interferon and ribavirin or who were treatment naïve. Patients enrolled in the trial were randomized to receive 150 mg of simeprevir and 400 mg of sofosbuvir once daily with or without ribavirin for either 12 or 24 weeks.

                           SVR12 Among Patients with Genotype 1 HCV and Advanced Liver
                                    Fibrosis in Cohort 2 of the COSMOS Study*

                                              12 Weeks of Treatment

    Regimen          Simeprevir/Sofosbuvir (%)                                Simeprevir/Sofosbuvir +
                                                                                 Ribavirin (%)
    ---              ---                                         -------------

    Overall                                                                93                          93
    -------                                                               ---                         ---

     1a HCV                                                                88                          93
    without the Q80K

     1a HCV                                                               100                          88
    with the Q80K

     1b HCV                                                               100                         100
    --------                                                              ---                         ---

    IL28B CT                                                              100                          93
    --------                                                              ---                         ---

    IL28B TT                                                              100                          88
    --------                                                              ---                         ---

    METAVIR F4                                                             86                          91
    ----------                                                            ---                         ---

*Excluding non?virologic failures

The most common adverse events reported during the study were fatigue, headache, nausea, anemia, pruritus, dizziness, rash and photosensitivity. One patient discontinued treatment due to adverse events.

Previously presented data from cohort 1 demonstrated that 93 percent and 96 percent of patients with METAVIR F0-F2 scores treated with simeprevir and sofosbuvir with or without ribavirin, respectively, for 12 weeks achieved SVR12.

                                   SVR12 Among Patient Subgroups with Genotype 1 HCV and METAVIR
                                           Scores F0-F2 in Cohort 1 of the COSMOS Study*

                                                       12 Weeks of Treatment

    Regimen    Simeprevir/Sofosbuvir (%)                                         Simeprevir/Sofosbuvir +
                                                                                    Ribavirin (%)
    ---        ---                               -------------

    IL28B CT                                                                 100                         100
    --------                                                                 ---                         ---

    IL28B TT                                                                  67                          83
    --------                                                                 ---                         ---

    METAVIR F2                                                               100                          94
    ----------                                                               ---                         ---

*Excluding non?virologic failures

In genotype 1a patients with the Q80K polymorphism at baseline, 89 percent and 83 percent achieved SVR12 after 12 weeks of treatment with and without ribavirin, respectively. Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR. In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93 percent achieved SVR, while 57 percent achieved RVR. The most common adverse events in both treatment arms were fatigue, headache, nausea and insomnia. Two patients discontinued treatment due to adverse events.

“The COSMOS data presented at The International Liver Congress(TM) 2014 add to the growing body of data demonstrating the efficacy and safety of simeprevir-based treatment regimens,” said Gaston Picchio, Hepatitis Disease Area Leader, Janssen Research & Development. “Janssen remains committed to exploring the utility of simeprevir in these different combinations.”

About simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis in September 2013 in Japan, in November 2013 in Canada and the U.S., and in March 2014 in Russia. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C and the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic HCV. This application is under review by the EMA.

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, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Janssen Pharmaceutical Companies
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 regarding product development. 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 known 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: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; 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; general industry conditions including 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 Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)

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