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J&J, GSK waltz into PhIII trials for rheumatoid arthritis contender

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In search of alternatives to blockbuster rheumatoid arthritis (RA) drugs, Johnson & Johnson's ($JNJ) Janssen Biologics unit has embarked on a pair of late-stage studies of an experimental antibody called sirukumab for patients with the inflammatory disease who failed treatment on anti-TNF-alpha drugs and other RA therapies.

Sirukumab, which the J&J unit is developing under a partnership with GlaxoSmithKline ($GSK), blocks the natural protein cytokine interleukin-6 (IL-6). The protein causes problems in diseases such as RA in which the immune system attacks healthy tissues. The drug is among a bevy of biologics and oral small-molecule contenders under development for the multibillion-dollar market for treating RA, which affects 1.5 million Americans and 23.5 million people around the world.

Johnson & Johnson holds dearly to the RA market, in which it sells the anti-TNF injections Remicade and Simponi with partner Merck ($MRK). Remicade, which is used for a host of inflammatory conditions, is one of the best-selling biotech drugs in the world. Yet not all patients are successfully treated with the drug and others on the market, leaving room for new treatment options such as sirukumab.

In one of the two Phase III trials dubbed "SIRROUND-T," Janssen plans to study how well sirukumab (or CNTO 136) reduces signs and symptoms of RA in patients whose disease is active despite treatment on anti-tumor necrosis factor (TNF)-alpha treatments. The other study, called "SIRROUND-D," tests the drug in patients who have failed treatment on disease-modifying anti-rheumatic drugs, measuring how well its treatment tamps down on signs and symptoms of the disease as well as radiographic progression of RA.

"We are focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis," said Dr. Jerome A. Boscia, vice president and head of immunology development at Janssen Research & Development, in a statement. "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."

- here's the release

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