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

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TITUSVILLE, N.J., Nov. 1, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. today 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 for the treatment of hepatitis C (HCV). The regimen will include Janssen's investigational protease inhibitor simeprevir (TMC435) and Vertex's investigational nucleotide analogue HCV polymerase inhibitor VX-135. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135. The DDI study will support the initiation of the Phase 2 study in early 2013 pending discussions with regulatory authorities.

The goal of the Phase 2 study will be to evaluate the safety, tolerability and viral cure rates of a 12-week regimen of simeprevir and VX-135, administered with and without ribavirin, in treatment-naive patients who have chronic non-cirrhotic genotype 1 HCV. The companies will jointly fund development costs associated with the collaboration. There are no up-front or milestone payments associated with the agreement.

Simeprevir is an investigational NS3/4A protease inhibitor currently in Phase 3 trials, developed in collaboration with and licensed from Medivir AB. VX-135 is an investigational uridine nucleotide analogue pro-drug designed to inhibit the replication of HCV by acting on the NS5B polymerase. 

"There is a significant unmet need for all-oral treatment regimens for people living with hepatitis C," said Wim Parys, Global Head of Infectious Diseases at Janssen. "Janssen's collaboration with Vertex underscores our commitment to better understand the potential utility of simeprevir in a number of different interferon-free treatment combinations and HCV patient populations."

About Simeprevir
Simeprevir (TMC435) is an NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic HCV infection. Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral (DAA) 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 treatment-experienced 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 other 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.

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. and Janssen Research & Development are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

About Vertex and VX-135
To find out more about Vertex and VX-135 please visit www.vrtx.com.

(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.