8-KRegulation FDOther EventsExhibits & Filings

REGENERON PHARMACEUTICALS, INC. 8-K Report, Regulation FD Disclosure (Dec 5, 2011)

Filed December 5, 2011For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on December 5, 2011, reporting updates on two key drug candidates, ZALTRAP and EYLEA. Regarding ZALTRAP, Regeneron announced top-line results from the Phase 2 AFFIRM trial for metastatic colorectal cancer. While the primary endpoint of one-year Progression Free Survival (PFS) was similar between the ZALTRAP plus chemotherapy arm and the chemotherapy-alone arm, the study was not designed for direct statistical comparison, with the control arm serving as an internal benchmark. The safety profile of ZALTRAP was consistent with prior trials and other anti-VEGF agents. Separately, Regeneron and its collaborator Bayer HealthCare announced positive two-year Phase 3 results for EYLEA in wet age-related macular degeneration (AMD), indicating sustained improvement in visual acuity.

Key Highlights

  • 1Regeneron announced top-line results from the Phase 2 AFFIRM trial for ZALTRAP in first-line metastatic colorectal cancer.
  • 2The AFFIRM trial showed a similar one-year Progression Free Survival (PFS) rate between ZALTRAP + mFOLFOX6 and mFOLFOX6 alone, with the control arm used as an internal benchmark.
  • 3The side effect profile of ZALTRAP in the AFFIRM trial was consistent with previous studies and other anti-VEGF agents.
  • 4Sanofi has submitted a Biologics License Application (BLA) to the FDA for ZALTRAP in previously treated metastatic colorectal cancer patients.
  • 5Regeneron and Bayer HealthCare announced two-year Phase 3 results for EYLEA in wet age-related macular degeneration (AMD).
  • 6The Phase 3 VIEW 1 and VIEW 2 studies for EYLEA demonstrated sustained improvement in visual acuity over two years in wet AMD patients.

Frequently Asked Questions

The Phase 2 AFFIRM trial in first-line metastatic colorectal cancer reported that the one-year Progression Free Survival (PFS) rate was similar in patients receiving ZALTRAP combined with mFOLFOX6 chemotherapy compared to patients receiving mFOLFOX6 chemotherapy alone. However, the study was not designed for a direct statistical comparison between the two arms, with the control arm serving only as an internal benchmark. The safety profile was consistent with expectations for ZALTRAP and other anti-VEGF agents.

While the AFFIRM trial reported Phase 2 results, Regeneron's collaborator Sanofi has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for ZALTRAP specifically for patients with previously treated metastatic colorectal cancer. The 8-K does not indicate approval status, only the submission.

Regeneron and Bayer HealthCare announced positive two-year results from Phase 3 studies (VIEW 1 and VIEW 2) for EYLEA in patients with the neovascular form of age-related macular degeneration (wet AMD). These results showed a sustained improvement in visual acuity over the two-year treatment period.