Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis

CORK, Ireland and SPRING HOUSE, Pennsylvania, Aug. 23, 2012 /PRNewswire/ -- Janssen Biologics (Ireland) announced today it has initiated the Phase 3 development program for sirukumab (CNTO 136) as part of a collaboration with GlaxoSmithKline plc (GSK).  Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody being studied for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). 

"We are focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  "We are pleased to be collaborating with GlaxoSmithKline on the clinical development of sirukumab, a protein therapeutic that we believe may represent an important treatment option for immunological diseases in the future."

The two studies comprising the Phase 3 program are:

• SIRROUND-T: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite anti-tumor necrosis factor (TNF)-alpha therapy. The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory or intolerant to anti-TNF-alpha agents. 
• SIRROUND-D: A multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab administered subcutaneously in subjects with active RA despite disease modifying anti-rheumatic drug (DMARD) therapy. The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA and inhibition of radiographic progression in subjects with active RA who are refractory to DMARDs.

About Sirukumab (CNTO 136)
Sirukumab is an investigational human monoclonal IgG1 kappa antibody in Phase 3 development for the treatment of moderately to severely active rheumatoid arthritis (RA).  It is not approved as a treatment for RA or any other indication anywhere in the world.  Sirukumab targets the cytokine interleukin (IL)-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. 

In December 2011, Janssen Biologics (Ireland) and GSK entered into a co-development and co-commercialisation license agreement with respect to sirukumab for RA.  Prior to the agreement, Janssen Research & Development, LLC, had been developing sirukumab for RA.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.  It is estimated that 1.5 million Americans and more than 23.5 million people worldwide are affected by the condition, for which there is no cure.

About Janssen Biologics (Ireland) and Janssen Research & Development, LLC
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 bring innovative products, services and solutions to people throughout the world.

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