Simeprevir (TMC435) Data In Hepatitis C To Be Presented At The AASLD

SOURCE Janssen Research & Development Ireland (Janssen)

BOSTON, Oct. 16, 2012 /PRNewswire/ -- Janssen Research & Development Ireland (Janssen) will present new data on simeprevir (TMC435), an investigational protease inhibitor, in hepatitis C (HCV) patients at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which takes place November 9 to 13 in Boston.

"We are pleased that these data have been selected for presentation at the AASLD annual meeting," said Wim Parys, Head of Infectious Diseases, Janssen. "The data represent an important step forward in Janssen's efforts to understand the potential utility of simeprevir in a number of different treatment combinations and hepatitis C patient populations."

Simeprevir is being studied in Phase III trials as a once-daily oral treatment in combination with pegylated interferon (IFN) and ribavirin (RBV) for genotype 1 HCV patients. It is also being studied in separate Phase II studies with other direct-acting antiviral (DAA) agents as part of IFN-free regimens, with and without RBV.

The data to be presented at the 2012 annual meeting of the AASLD include:

Oral Presentation: Parallel Session 12, HCV New Agents: Hard to Treat Patients, Hynes Ballroom B & C, November 11, 4:45 - 6:15 p.m. (ET)

• Efficacy and tolerability of TMC435 150 mg once daily with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)
  • Lead Author: Fred Poordad, M.D., Alamo Medical Research Center, San Antonio, TX
• No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus
  • Lead Author: Sivi Ouwerkerk-Mahadevan, M.D., Janssen Research & Development

Poster Presentations: Clinical HCV 1, Poster Hall, November 11, 8:00 a.m. - 5:30 p.m. (ET)

• Safety and tolerability of TMC435 in combination with peginterferon alfa-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naive and -experienced patients (Phase IIb PILLAR and ASPIRE trials)
  • Lead Author: Michael W. Fried, M.D., University of North Carolina at Chapel Hill, Chapel Hill, NC
• No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone
  • Lead Author: Sivi Ouwerkerk-Mahadevan, M.D., Janssen Research & Development

About Simeprevir Simeprevir (TMC435) is an 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 (IFN) and ribavirin (RBV), and in combination with direct-acting antiviral (DAA) agents in all oral IFN- free regimens, with and without RBV.

Global Phase III studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior IFN-based treatment and ATTAIN in treatment-experienced patients. In parallel to these trials, Phase III studies for simeprevir are ongoing in both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 infected patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in Phase II IFN-free trials with or without RBV 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 in treatment-naive or previous null responder HCV genotype 1 patients.

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

About Hepatitis C  Hepatitis C (HCV), 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 HCV 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 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 Research & Development 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; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. 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.)

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