22 July 2016
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, has been informed by its partner Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) of the receipt of a Complete Response Letter from the U.S. FDA concerning latanoprostene bunod which resulted in the attached press release issued by Valeant today. The text of this press release is copied below.
VALEANT PHARMACEUTICALS RECEIVES
COMPLETE RESPONSE LETTER FROM THE FDA
No Safety or Efficacy Concerns or Additional Clinical Trials Identified
for Approval of Latanoprostene Bunod
FDA Letter Related to CGMP at Bausch + Lomb Facility
LAVAL, QUEBEC– July 22, 2016 – Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA’s letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.