8-KRegulation FD

REGENERON PHARMACEUTICALS, INC. 8-K Report, Regulation FD Disclosure (Dec 21, 2011)

Filed December 21, 2011For Securities:REGN

Summary

This 8-K filing from Regeneron Pharmaceuticals, Inc. reports a significant development concerning ZALTRAP® (aflibercept), a drug developed in collaboration with Sanofi. Sanofi has voluntarily withdrawn the Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA) for marketing approval of ZALTRAP® in previously treated metastatic colorectal cancer. This withdrawal is planned to be followed by a re-submission in early 2012. The reason cited for the withdrawal pertains to comments received from the FDA regarding the Chemistry, Manufacturing, and Controls (CMC) section of the BLA. While this represents a delay in the approval timeline, it is important to note that the withdrawal is not based on efficacy or safety concerns of the drug itself, but rather on manufacturing and control aspects. Investors should monitor the re-submission process and the FDA's subsequent review.

Key Highlights

  • 1Sanofi voluntarily withdrew the BLA for ZALTRAP® (aflibercept) with the FDA on December 19, 2011.
  • 2The BLA was for marketing approval in previously treated metastatic colorectal cancer.
  • 3Sanofi plans to re-submit the BLA in early 2012.
  • 4The withdrawal was based on FDA comments concerning the Chemistry, Manufacturing, and Controls (CMC) section of the BLA.
  • 5ZALTRAP® is being developed through a worldwide collaboration between Regeneron and Sanofi.
  • 6The withdrawal is not related to the drug's efficacy or safety profile.

Frequently Asked Questions

Sanofi withdrew the BLA due to comments from the FDA specifically related to the Chemistry, Manufacturing, and Controls (CMC) section of the application. This indicates a need to address manufacturing processes or quality control measures before re-submission.

While the approval timeline is delayed, the withdrawal is not based on efficacy or safety concerns of ZALTRAP®. Sanofi intends to re-submit the BLA in early 2012, suggesting that the issues are addressable and the development program is expected to continue.

The filing confirms that ZALTRAP® is being developed under a worldwide collaboration between Regeneron and Sanofi. This partnership remains active, with both companies working towards regulatory approval.

The original timeline for potential approval has been extended. Sanofi plans to re-submit the BLA in early 2012. The FDA's review period following re-submission will determine the new expected approval date, which is not yet specified.