Nicox Granted New Patent for NCX 470, Extending Exclusivity in Europe to 2039

Press Release
Nicox Granted New Patent for NCX 470, Extending Exclusivity in Europe to 2039
October 29, 2020 – release at 7:30 am Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the European Patent Office has granted a formulation patent for NCX 470, extending the European exclusivity to 2039. The equivalent U.S. patent has already been granted, and NCX 470 is also covered by granted composition of matter patents. Gavin Spencer, Chief Business Officer at Nicox, said: “We are pleased that our formulation patent for NCX 470 has been granted in Europe, following the U.S. grant earlier in the year. This strengthens our competitive position and provides further protection of this potential best-in-class product candidate for the lowering of intraocular pressure as we continue Phase 3 development and move it towards commercialization.” NCX 470, Nicox’s lead clinical product candidate, is a novel second-generation nitric oxide (NO)-donating bimatoprost analog for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is currently being evaluated in the Mont Blanc Phase 3 clinical trial which was initiated in the U.S. in June 2020 with top-line results currently expected in Q4 2021. A second Phase 3 trial, Denali, is expected to start by the end of 2020, and will include clinical sites in both the U.S. and China, with the majority of the patients to be recruited in the U.S. NCX 470 is exclusively licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets. The Denali trial is jointly funded by Nicox and Ocumension.
About NCX 470
NCX 470 is a novel, potential best-in-class, second generation nitric oxide (NO)-donating bimatoprost analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated. It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye’s aqueous humor drainage system in the front of the eye. In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs. NCX 470 is designed to release both bimatoprost and NO following instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by Allergan, Inc., is one of the leading products in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension.
About Nicox
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel, second-generation nitric oxide-donating bimatoprost analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE™ in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets. 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.
Analyst coverage
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.
Contacts
Nicox Gavin Spencer Executive Vice President, Chief Business Officer & Head of Corporate Development T +33 (0)4 97 24 53 00 communications@nicox.com
Investors & Media United States & Europe LifeSci Advisors, LLC Mary-Ann Chang T +44 7483 284 853 mchang@lifesciadvisors.com	Media France LifeSci Advisors, LLC Sophie Baumont M +33 (0)6 27 74 74 49 sophie@lifesciadvisors.com
Forward-Looking Statements
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 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website (www.nicox.com).
Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T +33 (0)4 97 24 53 00 F +33 (0)4 97 24 53 99

Attachment

• EN_NCX 470 EUFormulation Patent Approval PR_20201029_F1 (1)