8-KRegulation FDExhibits & Filings

REGENERON PHARMACEUTICALS, INC. 8-K Report, Regulation FD Disclosure (Jun 27, 2011)

Filed June 27, 2011For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) announced positive results from its Phase 3 VELOUR trial for ZALTRAP (aflibercept) in combination with FOLFIRI for the second-line treatment of metastatic colorectal cancer (mCRC). The trial met its primary endpoint, demonstrating an improvement in overall survival (OS) compared to FOLFIRI plus placebo. These findings, presented at the ESMO World Congress on Gastrointestinal Cancer, represent a significant milestone for Regeneron's lead product candidate and its potential in a key oncology indication. The data presented suggests ZALTRAP could offer a meaningful therapeutic benefit to patients with advanced colorectal cancer. This development is crucial for investors as it advances the commercial prospects of aflibercept and reinforces Regeneron's drug development pipeline. The company has furnished a presentation detailing these trial results, providing investors with direct insight into the scientific and clinical validation of ZALTRAP.

Key Highlights

  • 1Regeneron's Phase 3 VELOUR trial for ZALTRAP (aflibercept) met its primary endpoint in metastatic colorectal cancer (mCRC).
  • 2The trial demonstrated improved overall survival (OS) when ZALTRAP was combined with FOLFIRI chemotherapy compared to FOLFIRI plus placebo.
  • 3The positive results were presented at the ESMO World Congress on Gastrointestinal Cancer.
  • 4ZALTRAP is being evaluated in combination with FOLFIRI for the second-line treatment of mCRC.
  • 5A presentation detailing the VELOUR trial results has been furnished as an exhibit to the 8-K filing.

Frequently Asked Questions

The positive results from the VELOUR trial are highly significant as they demonstrate that ZALTRAP (aflibercept) in combination with FOLFIRI chemotherapy improved overall survival in patients with metastatic colorectal cancer (mCRC). This success advances the development of ZALTRAP, a key product candidate for Regeneron, and strengthens its potential commercial viability in a major oncology market.

ZALTRAP is being studied for the second-line treatment of metastatic colorectal cancer (mCRC) in combination with the FOLFIRI chemotherapy regimen.

The results of the VELOUR trial were presented at the ESMO World Congress on Gastrointestinal Cancer, held in Barcelona, Spain.

More detailed information about the VELOUR trial results can be found in the presentation furnished as Exhibit 99.1 to this Current Report on Form 8-K filed by Regeneron Pharmaceuticals, Inc.