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.