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Centocor's new psoriasis medicine a success in testing

An experimental psoriasis medicine - a biologic that works in a new way from current therapies - cleared away or significantly reduced the red, scaly skin patches after 12 weeks of use.

An experimental psoriasis medicine - a biologic that works in a new way from current therapies - cleared away or significantly reduced the red, scaly skin patches after 12 weeks of use.

Researchers said the medicine from Centocor Inc., of Horsham, proved safe and highly effective in a late-stage Phase 3 trial, making it a potentially strong competitor to current leading treatments and a next-generation drug to Centocor's Remicade.

More than two-thirds of patients suffering from moderate to severe psoriasis had at least a 75 percent reduction in inflammation after 12 weeks and two doses of the injectable medicine, still known only by its laboratory name, CNTO 1275, researchers said.

"The efficacy of this drug was very impressive. As early as four weeks, there was a pretty remarkable difference," said Craig Leonardi, a St. Louis University Medical School dermatologist who led the study for Centocor. "It worked fast, and it worked in the vast majority of patients who received the medication."

The findings, presented yesterday at the World Congress of Dermatology in Buenos Aires, Argentina, attracted attention in the dermatology community because CNTO 1275 works by a different mechanism of blocking an inflammation-causing protein, called tumor necrosis factor, or TNF. The current anti-TNF therapies are Enbrel, sold by Collegeville-based Wyeth and Amgen Inc.; Humira, made by Abbott Laboratories; and Centocor's own Remicade.

Centocor's new human monoclonal antibody works by blocking the naturally occurring proteins Interleukin-12 and Interleukin-23, which are responsible for triggering inflammation in a number of severe autoimmune and inflammatory disorders.

Centocor, a subsidiary of Johnson & Johnson, plans to file for U.S. regulatory approval of CNTO 1275 by the end of the year.

"There were more side effects that occurred in the patients who received the placebo than the patients who received the medication," said Leonardi, who presented the results in Buenos Aires from the first 28 weeks of testing.

The study is ongoing, and Centocor plans to follow the patients for five years.

Psoriasis affects 7.5 million Americans and about 125 million people worldwide. A private research firm, Research and Markets, estimated this year that worldwide psoriasis-treatment sales totaled between $1 billion and $3 billion; Centocor is aiming to capture more of that market.

A side effect of current leading anti-TNF treatments for psoriasis and other autoimmune-disorder drugs is infections, including rare cases of tuberculosis and even multiple sclerosis.

More than 1,200 patients participated in the study. They received either a placebo or the drug, given in one of two doses, 45 milligrams or 90 milligrams.

In the study, two patients taking a placebo developed cellulitis, a skin infection, compared with one patient on the medication. One death was reported, although physicians determined it was not likely related to the drug because the patient had "significant heart disease" before the trial, Leonardi said.

"This is one of the cleanest safety profiles that I've ever seen," he said. "I've been working with the new drugs for psoriasis since 1999."

"The caveat here is that it's a new drug," he said. "We'll know more about this drug when it's in 10,000 human beings. But here and now, based on what we know, this is a very important advance," Leonardi said.

The drug, known by the chemical name ustekinumab, is self-injected by the patient, not administered by intravenous infusion in a doctor's office.

An advantage is that patients receive the medicine infrequently, Leonardi said. After the first two doses, which are four weeks apart, an injection is called for every 12 weeks.

Centocor, which employs 2,400 in Horsham, Malvern and Chesterbrook, discovered ustekinumab in its own labs.

Abbott Laboratories has a new drug, ABT 874, that works in the same way as Centocor's CNTO 1275. Abbott is "about a year and a half" behind Centocor in development, Leonardi said. Abbott reported favorable results in a mid-stage Phase 2 trial.