FDA clears potential blockbuster arthritis drug

The Food and Drug Administration on Friday approved a potential blockbuster drug from Johnson & Johnson that fights three forms of arthritis caused by immune-system disorders.

The injectable medication called Simponi is essentially a follow-up to the multibillion-dollar drug Remicade, which is marketed in the U.S. by J&J and in Europe and other countries by Schering-Plough Corp. Combined sales of the drug were over $5 billion last year.

Sales of the new drug would be similarly split between the two companies.

FDA regulators have approved the drug for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, a painful, progressive form of spinal arthritis. All three forms of arthritis are chronic disorders in which the immune system attacks joints, causing stiffness, pain and restricted motion.

The drug is injected under the skin once a month and is designed to be used alongside immune-system supressing drugs.

J&J and Schering have touted the drug as the new standard of so-called tumor necrosis factor blockers, a group of drugs that includes Wyeth and Amgen's Enbrel and Abbott Laboratories' Humira. Unlike Simponi, those drugs are generally injected once every week or two weeks.

The drug class works by targeting and neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.

The moneymaking potential of Simponi and Remicade are among the reasons Merck & Co., of Whitehouse Station, N.J., is acquiring Schering-Plough for $41.1 billion.

Merck has structured its purchase of Kenilworth, N.J.-based Schering-Plough as a reverse merger in hopes of avoiding change-of-control provisions in Schering's deal with J&J. Under those rules, marketing rights of Remicade would revert to J&J, wiping out the roughly $2 billion in profits that Schering makes from Remicade each year.

Simponi, known generically as golimumab, was discovered and developed by J&J's Centocor Ortho Biotech Inc. unit.

Shares of J&J fell 48 cents Friday to close at $50.92.