|Nicox Receives Formulation Patent Extending |
NCX 470 U.S. Patent Coverage to 2039
February 3, 2020 – release at 7:30 am CET
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.
|Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. By leveraging our proprietary expertise in nitric oxide (NO) donation and other technologies, we are developing an extensive portfolio of novel product candidates that target multiple ophthalmic conditions, including glaucoma. Our portfolio has three programs in development including NCX 470, a novel, second-generation NO-donating bimatoprost analog, for intraocular pressure lowering, based on our proprietary NO-donating research platform and NCX 4251, a proprietary formulation of the well-established molecule fluticasone, for acute exacerbations of blepharitis. Our research activities are focused on novel future generation NO-donors including NO-donating phosphodiesterase-5 (PDE5) inhibitors and NO-donating soluble guanylate cyclase (sGC) stimulators (in partnership with Cyclerion). In addition, we have two ophthalmology assets that have been approved by the U.S. Food and Drug Administration (FDA); VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and commercialized in the U.S. by Bausch + Lomb since December 2017, as well as ZERVIATE™ (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals, LLC. |
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
Bryan, Garnier & Co Victor Floc’h Paris, France
Cantor Fitzgerald Louise Chen New York, U.S.
H.C. Wainwright & Co Yi Chen New York, U.S.
Oppenheimer & Co Hartaj Singh New York, U.S.
|The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.|
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|The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. |
Risks factors which are likely to have a material effect on Nicox’s business are presented in the 4th chapter of the ‘Document de référence, rapport financier annuel et rapport de gestion 2018’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2019 which are available on Nicox’s website (www.nicox.com).
|Nicox S.A. |
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
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