Novartis ends IL-1 Trap deal with Regeneron

Regeneron Pharmaceuticals of the USA has reported that Swiss drug major Novartis has decided to forgo its right to jointly develop and commercialize the company's rheumatoid arthritis drug IL-1 Trap.

The US firm said, in a statement, that Novartis made its decision after evaluating the results of a Phase II trial. The Swiss company told Regeneron that it would only continue clinical development of the drug if the terms of the collaboration were revised. However, Regeneron said it had declined to accept the revisions to the agreement proposed by Novartis and, subsequently, the latter has elected not to proceed with the joint development of IL-1 Trap.

Results of the multicenter, randomized, placebo-controlled, double-blind Phase II study involving 200 patients with active RA, were released last year (Marketletter October 13, 2003). IL-1 Trap failed to meet its primary endpoint of an improvement of at least 20% on the American College of Rheumatology criteria when tested at 25mg, 50mg and 100mg doses; at the highest dose, 46% of subjects achieved an ACR20 response compared to 30.9% in the placebo group, but this difference was not statistically significant.