Regeneron has several investigational product candidates progressing through all stages of human clinical trials for a diverse set of serious diseases including cancer, eye diseases, and inflammatory diseases. The Company draws on strong internal capabilities and its collaborations with the sanofi-aventis Group and Bayer HealthCare to manage these significant clinical efforts. Regeneron and sanofi-aventis have also entered into a global, strategic collaboration to discover, develop, and commercialize fully-human therapeutic antibodies. Regeneron manufactures its commercial product and its clinical supplies from its large-scale GMP production facility in Rensselaer, New York.
Aflibercept (VEGF Trap)
Sanofi-aventis and Regeneron initiated a large phase 3 program studying aflibercept in combination with standard chemotherapy regimens in August 2007. Aflibercept is also completing several single agent phase 2 clinical trials in different cancer indications.
VEGF Trap-Eye
In August 2007, Regeneron and Bayer HealthCare initiated a phase 3 study of VEGF Trap-Eye in the neovascular form of wet wet Age-related Macular Degeneration (AMD). The VIEW 1 study is comparing VEGF Trap-Eye and ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.), an anti-angiogenic agent approved for use in wet AMD. This trial is the first study in the companies' phase 3 global development program in wet AMD, which will be carried out in the US, Europe, and other parts of the world.
Rilonacept (IL-1 Trap)
Regeneron also is evaluating the potential use of rilonacept in other indications in which IL-1 may play a role.
REGN88
The first therapeutic antibody to enter clinical development from Regeneron's VelocImmune® platform and the collaboration with sanofi-aventis is REGN88, a fully-human antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. IL-6 is a signaling protein broadly involved in the regulation of immune and inflammatory responses. In fact, IL-6 is found at many sites of inflammatory response within the body. IL-6 has been shown to be an important mediator of inflammation in rheumatoid arthritis.
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.