Centocor Inc.’s Remicade is inflating - both in uses and sales - having received a third approval in a rheumatoid arthritis indication.

The FDA approved Remicade (infliximab), in combination with methotrexate, to improve physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone. Although this is not Remicade’s first approval for rheumatoid arthritis, it is now the pilot drug to help patients perform daily activities such as dressing or walking up stairs.

“It’s great news for [rheumatoid arthritis patients],” said Bill Newbould, manager, corporate communications, at Malvern, Pa.-based Centocor. “For the first time they have a medication that makes them feel better but it also improves their physical function. We are not just reducing the signs and symptoms, but we also are altering the course of the disease.”

Remicade also is approved in combination with methotrexate for reducing the signs and symptoms of the disease, as well as for inhibiting the progression of joint damage, approvals that came in 1999 and 2000, respectively. (See BioWorld Today, Nov. 11, 1999, and July 13, 2000.)

However, Remicade spreads beyond rheumatoid arthritis; it is approved to treat the reduction of signs and symptoms in moderately to severely active Crohn’s disease in patients who have had an inadequate response to conventional therapy and also is indicated for reducing the number of draining enterocutaneous fistulas in patients with fistulizing Crohn’s disease. Centocor has a supplemental biologics license application under review by the FDA for inducing and maintaining clinical remission in patients with moderately to severely active Crohn’s disease. (See BioWorld Today, Aug. 25, 1998.)

Centocor was acquired by Johnson & Johnson, of New Brunswick, N.J., in October 1999, for about $4.9 billion and now operates as a wholly owned subsidiary. The revenue Remicade pulls in is added to the big-pharmaceutical sums J&J boasts $33 billion in total worldwide sales in 2001 but Remicade’s U.S. numbers are impressive and growing. Remicade brought Centocor $370 million in 2000 and $721 million in 2001. Although Centocor has U.S. marketing rights, Schering-Plough Corp. has rights outside of the U.S., except in Japan and parts of the Far East, where Osaka, Japan-based Tanabe Seiyaku Ltd. has rights.

Remicade, a monoclonal antibody that blocks the activity of tumor necrosis factor alpha, is given intravenously and requires six to eight infusions per year. At that rate, the drug costs between $10,000 and $12,000 annually. Its main competition on the market is Seattle-based Immunex Corp.’s Enbrel, which also is approved to treat rheumatoid arthritis, as well as psoriatic arthritis. Like Remicade, Enbrel is a tumor necrosis factor inhibitor.

And like Enbrel, Remicade is in development for several other indications.

“We think the drug has significant potential in a wide range of immune-mediated inflammatory diseases,” Newbould told BioWorld Today. “We are pursuing development in psoriasis, psoriatic arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis. We are also looking at it in ulcerative colitis.”

Newbould said that as Remicade grows in uses, besides being good news for patients, it is setting an example for others.

“Doctors and patients expect more from biologics,” he said. “Remicade is raising the bar. [Centocor] is delivering on the promise of biotech.”