Washington Editor

Centocor Inc. is out-licensing rights to a late-stage inflammatory disease to a familiar partner, Schering-Plough Corp., with which it already has a long-term agreement on Remicade (infliximab). In fact, the new arrangement bears a striking resemblance to their prior deal.

But Centocor spokesman Michael Parks said the still-investigational compound, CNTO 148, is not a second-generation version of that popular inhibitor of tumor necrosis factor-alpha, although it also has been developed for rheumatoid arthritis and other immune-mediated inflammatory diseases.

"It clearly has a lot of similarities to Remicade," he told BioWorld Today, "but it's a new formulation that is being investigated both for infused administration, as well as subcutaneously."

Remicade, which last year generated $2.1 billion in worldwide sales and is approved in nine indications, can be delivered only by way of an intravenous infusion at a doctor's office. Parks noted that CNTO 148 is being investigated as a second-generation biologic using its dual administration routes. The fully human monoclonal antibody, which targets and binds to TNF-alpha to neutralize TNF activity, has completed Phase II studies in rheumatoid arthritis, and Phase III is expected to begin early next year.

"Those plans already are in the works," Parks said.

Schering-Plough exercised its rights to develop and commercialize CNTO 148 upon seeing Phase II data, per terms of a 1998 agreement between the companies. In the process has reimbursed Horsham, Pa.-based Centocor for previous research costs. Specifically, Schering-Plough s option will result in a $125 million research and development charge this quarter. The companies did not disclose further financial terms, though going forward, both will share CNTO 148 s development and commercialization expenses.

Kenilworth, N.J.-based Schering-Plough is gaining exclusive worldwide marketing rights except in the U.S., Japan, China, Hong Kong, Taiwan and Indonesia. Under original terms of their long relationship, Schering-Plough holds Remicade's exclusive worldwide marketing rights, save for those same excluded territories.

But the companies are disputing the collaboration's duration. Centocor has said the CNTO 148 rights expire in 2014, but Schering-Plough said they extend beyond that date. Still, the partners are working to move their alliance forward while simultaneously resolving their differences on the expiration date.

Beyond CNTO 148, Centocor's clinical pipeline also includes CNTO 1275, a new molecular entity in clinical development for Crohn's disease and psoriasis. Unlike Remicade and CNTO 148, though, it is not an anti-TNF product.

Centocor is a subsidiary of Johnson & Johnson, of New Brunswick, N.J.

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