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REGN > SEC Filings for REGN > Form 8-K on 14-Sep-2009All Recent SEC Filings

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Form 8-K for REGENERON PHARMACEUTICALS INC


14-Sep-2009

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

On September 11, 2009, Regeneron Pharmaceuticals, Inc., together with sanofi-aventis, issued a press release announcing the discontinuation of the Phase 3 trial that evaluated aflibercept (VEGF Trap) plus gemcitabine versus placebo plus gemcitabine for the first-line treatment of metastatic pancreatic cancer (VANILLA), based on the recommendations by an Independent Data Monitoring Committee (IDMC). As part of a planned interim efficacy analysis, the IDMC determined that the addition of aflibercept to gemcitabine would be unable to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to placebo plus gemcitabine in this study. A copy of this press release is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

On September 14, 2009, Regeneron Pharmaceuticals, Inc. issued a press release announcing the completion of patient enrollment in two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). A copy of this press release is filed as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press Release dated September 11, 2009.
99.2 Press Release dated September 14, 2009.


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