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Regeneron Reports First Quarter 2013 Financial and Operating Results
Date:5/3/2013

to evaluate the efficacy and safety of EYLEA in the treatment of diabetic macular edema (DME).  Both studies are fully enrolled.  In February 2013, Bayer HealthCare initiated another Phase 3 DME trial, VIVID EAST-DME, in Russia, China, and other Asian countries.
  • The VIBRANT study of EYLEA in macular edema following branch retinal vein occlusion (BRVO) is now fully enrolled.
  • ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion

  • The Company and Sanofi collaborate on the global development and commercialization of ZALTRAP, and share profits and losses from commercialization of ZALTRAP except for Japan, where the Company will receive a royalty on sales. 
  • In February 2013, the European Commission (EC) granted marketing authorization in the European Union for ZALTRAP concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.  Marketing authorization applications for ZALTRAP are also currently under review by other regulatory agencies worldwide.
  • In the first quarter of 2013, Sanofi recorded worldwide net sales of ZALTRAP of $14 million.  
  • Monoclonal Antibodies

  • Regeneron has eleven fully human monoclonal antibodies based on the Company's VelocImmune® technology in clinical development, including six in collaboration with Sanofi.
  • ODYSSEY, a large, global Phase 3 program with alirocumab (REGN727), an antibody targeting PCSK9 to reduce LDL cholesterol, was initiated in June 2012 and is currently enrolling patients.  The Company expects to report initial results from a Phase 3 ODYSSEY trial in the second half of 2013.  Alirocumab is being developed in collaboration with Sanofi.
  • Positive proof of concept data from two Phase
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  • SOURCE Regeneron Pharmaceuticals, Inc.
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