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Efficacy and Safety Data from Phase 2B Trials of Janssen's 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

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- Data from Post Hoc Analyses of the ASPIRE and PILLAR Studies in Patients with Metavir Scores of F3 and F4 Show Sustained Viral Response Compared to Placebo -

BOSTON, Nov. 10, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today announced that the use of one once-daily pill of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin led to higher rates of sustained viral response at 24 weeks (SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who were treatment naive and treatment experienced with genotype 1 hepatitis C. Simeprevir was also generally well tolerated and the overall incidence of serious adverse events (AEs) was similar across all treatment arms. The data from the Phase 2b PILLAR and ASPIRE trials were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

In treatment-naive patients with a Metavir score of F3 (PILLAR), the primary endpoint of SVR24 was achieved in 79 percent of patients in the simeprevir group compared to 72 percent in the control group (pegylated interferon and ribavirin alone). In treatment-experienced patients with a Metavir score of F3 (ASPIRE), SVR24 was achieved in 48 percent of patients in the simeprevir group compared to 8 percent in the control group. In treatment-experienced patients with a Metavir score of F4 (ASPIRE), SVR was achieved in 62 percent of patients in the simeprevir group compared to 0 percent in the control group. In both the PILLAR and ASPIRE trials, serious AEs occurred in 7.6 percent of patients receiving simeprevir plus pegylated interferon and ribavirin compared to 9.8 percent of patients receiving pegylated interferon and ribavirin alone.

"Hepatitis C patients with Metavir scores of F3 and F4 have advanced fibrosis of the liver and are harder to cure than those with limited fibrosis," said Fred Poordad, M.D., chief medical officer of Alamo Medical Research Center and investigator in the ASPIRE and PILLAR studies. "The results presented at AASLD suggest that simeprevir could represent an important new treatment option for people living with advanced hepatitis C if proven in advanced trials."

Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment taken in combination with pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C. It is also being studied in separate Phase 2 trials with other direct-acting antiviral agents as part of interferon-free regimens, with and without ribavirin. This includes a recently initiated Phase 2a trial of an interferon-free regimen with simeprevir and TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in development for hepatitis C.

"We are encouraged by these data, which show sustained viral response and tolerability in both treatment-naive and more challenging-to-cure patients," said Maria Beumont, M.D., Medical Leader for simeprevir, Janssen Research & Development. "We look forward to further evaluating the utility of simeprevir in combination with other agents for the treatment of hepatitis C."

About the PILLAR & ASPIRE Trials  
In the two international, Phase 2b, randomized, double-blind, placebo-controlled studies, patients were either treatment naive (PILLAR) or treatment experienced (ASPIRE), and received pegylated interferon and ribavirin alone or in combination with once-daily simeprevir. In PILLAR, 309 treatment-naive hepatitis C patients received either 75 or 150 mg of once-daily simeprevir for 12 or 24 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks depending on their response to treatment. In ASPIRE, 396 treatment-experienced patients received either 100 or 150 mg of once-daily simeprevir for 12, 24 or 48 weeks plus pegylated interferon and ribavirin for 48 weeks.

The post hoc analyses of PILLAR and ASPIRE presented at AASLD (abstracts 83 and 769) evaluated only patients receiving 150 mg of simeprevir and reporting a Metavir score of F3 (PILLAR), or F3 and F4 (ASPIRE). The Metavir score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale. An F3 score means the patient has numerous septa (fibrous tissue bands that can decrease the flow of blood through the liver) without cirrhosis, while an F4 score means the patient has cirrhosis.

About Simeprevir   
Simeprevir (TMC435) is a NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral agents in all-oral interferon-free regimens, with and without ribavirin.

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 both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and in Japanese HCV genotype 1 patients.

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

  • Janssen's TMC647055 and ritonavir in treatment-naive, relapser or null-responder HCV genotype 1 patients;
  • Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV genotype 1 patients; and
  • Bristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or previous null-responder HCV genotype 1 patients.

In addition, Janssen recently announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated 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. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135.

For additional information about simeprevir, 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 and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 170 to 210 million people are infected with hepatitis C worldwide, with three to four million people newly infected each year.

About Janssen   
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, 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 Pharmaceuticals, Inc. 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 Pharmaceuticals, Inc. 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 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 January 1, 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. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen Pharmaceuticals, Inc.



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