Summary
Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on October 28, 2016, to disclose an "Other Event" related to manufacturing deficiencies identified by the U.S. Food and Drug Administration (FDA) at a Sanofi facility involved in the "fill and finish" process for sarilumab. Sarilumab is an investigational antibody for interleukin-6 receptor (IL-6R) being developed by Regeneron in collaboration with Sanofi. While Sanofi has responded to the FDA regarding these deficiencies and is in discussions, the outcome of the FDA's review of the facility's Current Good Manufacturing Practice (CGMP) status introduces uncertainty regarding the potential approval timing of sarilumab. Notably, Regeneron's own manufacturing facility for the sarilumab active pharmaceutical ingredient in Rensselaer, New York, has passed a pre-approval inspection without a Form 483 being issued, indicating no observed manufacturing violations by the FDA.
Key Highlights
- 1FDA identified manufacturing deficiencies at a Sanofi facility impacting sarilumab's 'fill and finish' process.
- 2Sanofi has provided responses to the FDA and is engaged in discussions regarding the cited deficiencies.
- 3The CGMP status of the Sanofi facility is under FDA review, creating uncertainty for sarilumab's approval timeline.
- 4Regeneron's sarilumab API manufacturing facility in Rensselaer, NY, passed its pre-approval inspection with no FDA Form 483 issued.
- 5Regeneron's sarilumab BLA remains under active FDA review with an expected action date of October 30, 2016.
- 6The company is providing forward-looking statements regarding potential risks and uncertainties, including regulatory actions and the impact on sarilumab's development and commercialization.