Sanofi (SNY) Alerts Regeneron (REGN) of FDA Concerns Related to Sarilumab Manufacturing Facility

October 28, 2016 6:16 AM EDT

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Regeneron (Nasdaq: REGN) disclosed the following in a U.S. SEC filing on Friday:

Item 8.01 - Other Events.

Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) has been advised by its collaborator Sanofi that manufacturing deficiencies have been raised by the U.S. Food and Drug Administration (the “FDA”) during a routine Current Good Manufacturing Practice (“CGMP”) inspection of a Sanofi manufacturing facility that conducts “fill and finish” activities for certain products, including sarilumab, an antibody to the interleukin-6 receptor (IL-6R) being developed by Regeneron in collaboration with Sanofi. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies and has been in discussions with the FDA. Given that the CGMP status of this facility is under review by the FDA, it is unclear whether or how this situation may impact the timing of the potential approval of sarilumab by the FDA. The sarilumab active pharmaceutical ingredient is manufactured by the Company at its Rensselaer, New York facility. The FDA has completed a pre-approval inspection of Regeneron’s sarilumab manufacturing facility. No Form 483 was issued in connection with the inspection, which is the form used if the FDA investigators have observed any conditions that in their judgement may constitute a violation of the Food, Drug, and Cosmetic Act and related acts. The sarilumab Biologics License Application continues to be under active review by the FDA, with an expected action date of October 30, 2016.



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