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By Shannon Pettypiece and Alex Nussbaum

April 24 (Bloomberg) -- Johnson & Johnson won U.S. approval of a rheumatoid arthritis drug designed to be injected less often than its top-selling product, Remicade, for the crippling disease.

The Food and Drug Administration announced its decision on the medicine, golimumab, in an e-mailed statement today. The drug, to be co-marketed outside the U.S. by Schering-Plough Corp., will compete with Amgen Inc.’s Enbrel and Abbott Laboratories’ Humira.

Remicade produced a more than $5 billion in combined revenue last year, according to the data research firm IMS Health Inc. It was the leading medicine for Johnson & Johnson and Schering-Plough last year, according to Bloomberg data. Annual sales of golimumab, to be sold under the brand-name Simponi, will exceed $1 billion a year, said Jeff Jonas, an analyst for Gabelli & Co. in Rye, New York.

“It’s a big drug,” Jonas said in a telephone interview April 13. “It’ll definitely be over $1 billion, which is blockbuster status, but it’ll probably reach $2 billion or $3 billion over the next few years.”

Golimumab was also approved for use against ankylosing spondylitis, a progressive form of spinal arthritis, and psoriatic arthritis, a form of arthritis often associated with the skin condition psoriasis.

J&J, based in New Brunswick, New Jersey, will sell the drug in the U.S. Schering-Plough, of Kenilworth, New Jersey, will sell it in most countries outside the U.S.

Monthly Injections

Shares of J&J fell 48 cents to $50.92 at 4 p.m. in New York Stock Exchange composite trading. Schering-Plough gained 28 cents, or 1.3 percent, to $22.17.

Like Enbrel, Humira, and Remicade, the new product works by blocking TNF, or tumor necrosis factor, a germ-fighting protein that also can cause the inflammation found in rheumatoid arthritis patients. Golimumab is injected monthly, rather than weekly or biweekly, said Roy Fleischmann, a lead researcher in golimumab studies and chief of rheumatology at St. Paul University Hospital in Dallas, in a telephone interview last year.

About 1.3 million people in the U.S. have rheumatoid arthritis, according to The Arthritis Society, an Atlanta-based nonprofit group. The disease can cause long-term joint damage, resulting in chronic pain and loss of movement.

Study Comparisons

As many as 38 percent of patients who switched to golimumab from other anti-TNF drugs reported improvement in their condition with less pain and stiffness, according to a study funded by Johnson & Johnson and Schering-Plough. After six months with golimumab, half of the subjects said dressing, writing, eating and other tasks were easier, compared with 34 percent who took a placebo.

Remicade came on the U.S. market in 1998 followed by Enbrel a few months later and Abbott Laboratories’ Humira in 2002. Remicade’s patent will expire in 2018, said Brian Kenney, a spokesman for J&J’s Centocor Ortho Biotech unit.

Merck & Co.’s planned acquisition of Schering-Plough for $44.5 billion, announced in March, may fuel a dispute over who gets revenue.

Under a contract provision, J&J may avoid sharing its revenue from golimumab if Schering-Plough is sold, analysts said.

Merck, based in Whitehouse Station, New Jersey, says it will be able to keep Schering-Plough’s portion of golimumab sales after the acquisition is complete. Merck cites the structure of the transaction as a reverse merger, where Schering-Plough will legally be the last company standing.

Golimumab will be co-marketed in Japan, Indonesia and Taiwan by Mitsubishi Tanabe Pharma Corp. and Janssen Pharmaceutical Kabushiki Kaisha, according to the companies.

The drug will be sold in Hong Kong by Janssen-Cilag and marketed by Xian-Janssen in China, Kenney said.

To contact the reporters on this story: Shannon Pettypiece in New York spettypiece@bloomberg.net; Alex Nussbaum in New York anussbaum1@bloomberg.net.

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