8-KRegulation FD

REGENERON PHARMACEUTICALS, INC. 8-K Report, Regulation FD Disclosure (Nov 3, 2011)

Filed November 3, 2011For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) announced through a Form 8-K filing on November 3, 2011, an update regarding the development of ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion, a drug developed in collaboration with Sanofi. This filing primarily serves to disclose information provided by Sanofi regarding ZALTRAP®. The key takeaway for investors is the progress in the regulatory approval process for ZALTRAP®. A Biologics License Application (BLA) for ZALTRAP® in the treatment of previously treated metastatic colorectal cancer was submitted to the U.S. Food and Drug Administration (FDA) in October 2011. Furthermore, Regeneron and Sanofi anticipate filing a regulatory application for marketing approval in the European Union during the fourth quarter of 2011. This dual regulatory submission timeline signals continued momentum in bringing ZALTRAP® to market.

Key Highlights

  • 1Sanofi provided updated information on ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion.
  • 2ZALTRAP® is being developed under a worldwide collaboration between Regeneron and Sanofi.
  • 3A Biologics License Application (BLA) for ZALTRAP® has been submitted to the U.S. FDA.
  • 4The BLA is for the indication of previously treated metastatic colorectal cancer.
  • 5Regulatory application filing in the European Union is expected in Q4 2011.

Frequently Asked Questions

ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion is a drug being developed by Regeneron and Sanofi. A Biologics License Application (BLA) for its use in previously treated metastatic colorectal cancer was submitted to the U.S. FDA in October 2011, and a European Union regulatory filing is anticipated in the fourth quarter of 2011.

The submission of the BLA to the FDA marks a significant step towards potential marketing approval for ZALTRAP® in the United States for the treatment of previously treated metastatic colorectal cancer. This indicates that the companies believe they have sufficient data to support approval.

Regeneron and Sanofi expect to file a regulatory application for marketing approval of ZALTRAP® in the European Union during the fourth quarter of 2011.

ZALTRAP® is being developed in a worldwide collaboration between Regeneron Pharmaceuticals, Inc. and Sanofi.