Strategic Alliances
Entering into strategic alliances enables Regeneron to enhance its product development programs by increasing access to knowledge, experience, expertise, and human and financial resources. Regeneron is dedicated to fostering collaborations with industry leaders to better position the Company for greater leadership, business output, and short- and long-term growth initiatives.
Marketed Products
Regeneron Pharmaceuticals, Inc. currently markets ARCALYST® (rilonacept) Injection for Subcutaneous Use for the treatment of a rare, inherited, inflammatory condition.
Clinical Development
Regeneron currently has six clinical development programs: aflibercept (VEGF Trap) in cancer, in collaboration with sanofi-aventis, and the VEGF Trap-Eye, in collaboration with Bayer HealthCare, rilonacept (IL-1 Trap), where the Company is currently evaluating the potential role of rilonacept in gout, REGN88, an antibody to the Interleukin-6 receptor (IL-6R), REGN421, an antibody to Delta-like ligand-4 (Dll4), and REGN475, an antibody to nerve growth factor (NGF). The Company has preclinical programs in other diseases and disorders.
Antibody Development Program
Regeneron and sanofi-aventis also entered into a global strategic collaboration in November 2007 to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron's proprietary VelociSuite of technologies. The first therapeutic antibody to enter clinical development under the collaboration is REGN88, an antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. The second is expected to be an antibody to Delta-like ligand-4 (Dll4), which is currently scheduled to commence clinical development in mid-2008. In addition to REGN88, antibodies to Delta-like ligand-4 (Dll4) and nerve growth factor (NGF) have also recently entered clinical development. It is the collaboration's goal to bring, on average, two to three new antibodies per year into clinical development.
Building upon its strong foundation in basic scientific research and discovery technology, Regeneron has added manufacturing and clinical development capabilities in order to become a fully integrated, biopharmaceutical company.
Technology
Regeneron's ability to develop product candidates is enhanced by proprietary technology platforms designed to identify specific genes for a particular disease or cell type and validate targets through high-throughput production of mammalian models. VelocImmune and cell line expression technologies are used to design and produce product candidates directed against the disease target. These technologies may accelerate the development of fully-human monoclonal antibodies.
Commercialization Strategy
Depending on the product and the indication, Regeneron may chose to commercialize products itself or to work in conjunction with a larger pharmaceutical partner. Regeneron is commercializing ARCALYST® (rilonacept) for the treatment of CAPS by itself. In the VEGF Trap-Eye collaboration, Regeneron retains US commercialization rights; the collaboration with sanofi-aventis provides Regeneron with shared global commercial rights to aflibercept, and the company's monoclonal antibodies.
Financial Position
Development costs for aflibercept are fully funded by sanofi-aventis. Regeneron and Bayer HealthCare are sharing development costs for the VEGF Trap-Eye. Regeneron entered into non-exclusive license agreements with AstraZeneca UK Limited and Astellas Pharma Inc. for use of the Company's VelocImmune® technology in generating monoclonal antibody product candidates. These agreements include annual licensing fees and single-digit royalties on product sales of commercialized antibody products discovered using VelocImmune.









