(GSK) GlaxoSmithKline-Johnson & Johnson Candidate in Phase III

GlaxoSmithKline (GSK) and Janssen Biologics’ (Ireland) human anti-interleukin (IL)-6 monoclonal antibody, sirukumab (CNTO 136), recently moved into a phase III program. Sirukumab is being developed for the treatment of moderately to severely active rheumatoid arthritis in adults.

Glaxo and Janssen said that the phase III program consists of two studies – SIRROUND-T and SIRROUND-D. The multicenter, randomized, double-blind, placebo-controlled, parallel group SIRROUND-T study will evaluate sirukumab’s efficacy on the basis of the reduction of the signs and symptoms of rheumatoid arthritis in patients with active rheumatoid arthritis who are refractory or intolerant to the anti-tumor necrosis factor (TNF)-? therapy.

Meanwhile, the multicenter, randomized, double-blind, placebo-controlled, parallel group SIRROUND-D study will evaluate sirukumab’s efficacy on the basis of the reduction of the signs and symptoms of rheumatoid arthritis and inhibition of radiographic progression in patients with active rheumatoid arthritis who are refractory to disease modifying anti-rheumatic drugs (DMARDs).

Janssen Biologics, a part of Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Companies, has an agreement with Glaxo for the development of sirukumab. The co-development and co-commercialization license agreement for sirukumab was signed in December 2011.

Johnson & Johnson already has a strong presence in the rheumatoid arthritis market, which represents significant commercial potential. About 1.5 million people in the US and more than 23.5 million people across the globe are estimated to suffer from rheumatoid arthritis. Johnson & Johnson has two products in its portfolio for rheumatoid arthritis – Remicade and Simponi. Johnson & Johnson is looking to strengthen its presence further in rheumatoid arthritis through the development of sirukumab.

We currently have a Neutral recommendation on Johnson & Johnson, which carries a Zacks #3 Rank (short-term ‘Hold’ rating). We, however, have an Underperform recommendation on Glaxo, which carries a Zacks #4 Rank (short-term ‘Sell rating). Glaxo’s second quarter results missed expectations. The company is facing headwinds like generic competition and EU pricing pressure.

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