Regeneron has six investigational product candidates progressing through all stages of human clinical trials for a diverse set of serious diseases including cancer, eye diseases, inflammatory diseases, and pain. The Company draws on strong internal capabilities and its collaborations with the sanofi-aventis Group and Bayer HealthCare to manage these significant clinical efforts.

Aflibercept (VEGF Trap)

In collaboration with sanofi-aventis, we have underway four Phase 3 studies of aflibercept in combination with chemotherapy that are targeted to enroll a total of approximately 4,000 patients. These studies are being conducted in first-line metastatic pancreatic cancer, first-line metastatic hormone-refractory prostate cancer, second-line non-small cell lung cancer, and second-line metastatic colorectal cancer. In addition, a Phase 2 combination study of aflibercept in first-line metastatic colorectal cancer began in the first quarter of 2009. Regeneron is also completing a Phase 2 study of single-agent aflibercept in patients with symptomatic malignant ascites (SMA), a condition where fluid accumulates in the abdominal cavity in women with advanced ovarian cancer.

VEGF Trap-Eye

Regeneron and Bayer HealthCare are conducting two Phase 3 studies of VEGF Trap-Eye in the neovascular form of wet Age-related Macular Degeneration (AMD). These trials are comparing treatment with VEGF Trap-Eye and Lucentis® (ranibizumab), a trademark of Genentech, Inc., an anti-angiogenic agent approved for use in wet AMD. In 2008, Regeneron and Bayer HealthCare also initiated a Phase 2 study of VEGF Trap-Eye in patients with Diabetic Macular Edema (DME). VEGF Trap-Eye is specifically purified and formulated for intravitreal administration.

Rilonacept (IL-1 Trap)

Regeneron is enrolling patients in a Phase 3 rilonacept gout program which will include two studies in the prevention of gout flares in patients initiating urate-lowering therapy, a study evaluating rilonacept in the treatment of acute gout flares, and an additional safety study.

Human Antibodies

Three human antibodies developed under the sanofi-aventis collaboration are in Phase 1 clinical studies: REGN88, an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis; REGN421, an antibody to delta-like ligand 4 (Dll4) that is in development to disrupt angiogenesis in patients with cancer; and REGN475, an antibody against nerve growth factor (NGF) that is in development for the treatment of pain.

This section discusses Regeneron's pipeline of drug candidates currently undergoing clinical testing in a variety of diseases. These drug candidates have not been approved by the United States Food and Drug Administration for the indications described in this section.