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Nicox to resubmit cetirizine NDA after manufacturing concerns are addressed
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Nicox S.A. announced that it received a Complete Response Letter from the FDA regarding the New Drug Application for AC-170 as a result of an inspection at a third-party facility that produces the active pharmaceutical agent, cetirizine, and supplies it to the manufacturer of the finished product.
AC-170 is Nicox’s novel, proprietary, cetirizine eye drop formulation for treating ocular itch associated with allergic conjunctivitis, according to a press release from the company.
Nicox stated that the safety and efficacy data in the AC-170 New Drug Application (NDA) have not resulted in the FDA requesting any further clinical or nonclinical testing, and the Complete Response Letter included no concerns regarding the finished product manufacturing facility.
Nicox said it is contacting its suppliers to assess the timeline for the active pharmaceutical ingredient manufacturer to address the FDA’s concerns and, when they have been addressed, Nicox will resubmit the NDA, according to the release.
The company noted that if the AC-170 NDA is approved prior to Dec. 1, ex-Aciex shareholders will receive a milestone payment of $35 million in Nicox shares, but only $10 million if approval comes after Dec. 1. AC-170 was developed by Aciex Therapeutics Inc., which became a wholly-owned subsidiary of Nicox in October 2014 and was renamed Nicox Ophthalmics Inc.