Nicox Receives Formulation Patent Extending NCX 470 U.S. Patent Coverage to 2039
February 3, 2020
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, has received approval from the U.S. Patent and Trademark Office of a formulation patent for NCX 470, extending the U.S. patent coverage to 2039.
NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, is Nicox’s lead clinical development program. NCX 470 ophthalmic solution 0.065% demonstrated non-inferiority and statistical superiority to latanoprost ophthalmic solution 0.005%, the U.S. market leader in prostaglandin analog prescriptions, in the Dolomites trial, a U.S., multicenter, Phase 2 safety and efficacy clinical trial.
An End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is scheduled in Q1 2020. The initiation of the first of the two U.S. Phase 3 clinical trials (“Mont Blanc”) is expected by the end of Q2 2020.
NCX 470 is covered by a composition of matter patent until 2029, which is potentially eligible for up to a 5-year patent term extension based on the period of regulatory review