Regeneron Pharmaceuticals, Inc (Tarrytown, NY), a biopharmaceutical company with therapeutic candidates in clinical trials for the potential treatment of cancer, age-related eye diseases, and inflammatory diseases, announced that it has discontinued its Interleukin-1 (IL-1) Trap program for adult rheumatoid arthritis (RA). The company has ended the Trap studies in response to the growing number of treatments in the market, which make it difficult to produce a commercial product.

In the first quarter of 2003, Regeneron and Novartis Pharma AG signed a collaborative arrangement to develop and commercialize the IL-1 Trap, a long-acting IL-1 inhibitor. In the second half of 2003, Regeneron completed a phase II dose-ranging clinical trial of the IL-1 Trap in approximately 200 patients with RA. The investigational drug demonstrated evidence of clinical activity and a favorable safety and tolerability profile. After evaluating the clinical data from the phase II trial, Novartis elected not to proceed with the joint development program, and the collaboration officially ended in mid-2004. Regeneron received approximately $150 million from Novartis over the course of the joint development program.

In June 2005, Regeneron announced positive preliminary results from an ongoing pilot study involving once-weekly subcutaneous dosing of the IL-1 Trap in patients with CIAS1 (cold autoinflammatory syndrome 1 protein)-associated periodic syndrome. The syndrome consists of a family of rare autoinflammatory diseases characterized by spontaneous systemic inflammation in the absence of immune dysregulation. All four patients enrolled in the study demonstrated a positive clinical response in both the initial loading dose phase and the ongoing chronic dosing phase of the study.

Regeneron has already initiated pilot studies in osteoarthritis and polymyalgia rheumatica. The company is currently in discussions with the FDA to finalize the design of a pivotal registration study, and plans to initiate a pilot study in systemic onset juvenile idiopathic arthritis. Both initiatives are planned to begin in the fourth quarter of 2005. 

As a result of the discontinuation of the Trap program, Regeneron announced that it intends to terminate approximately 165 employees—more than 20% of its total workforce—with most of the layoffs occurring by the end of 2005. The balance of the layoffs will occur following the completion of a manufacturing contract with Merck & Co, Inc. The company expects the layoffs will cost between $2.5 and 3.5 million in severance. As of June 30, 2005, cash and marketable securities totaled over $350 million.

—A. Techman