Nicox SA, an international ophthalmology company, announced that the Chinese National Intellectual Property Administration has granted the company a formulation patent for NCX 470, its lead product candidate in development for patients with open-angle glaucoma or ocular hypertension, extending coverage in China to 2039.
Nicox Granted New Patent for NCX 470 in China, Extending Coverage to 2039
February 21, 2022 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the Chinese National Intellectual Property Administration (CNIPA) has granted the company a formulation patent for NCX 470, its lead product candidate in development for patients with open-angle glaucoma or ocular hypertension, extending coverage in China to 2039. With the equivalent U.S. and European patents already granted, the formulation is now covered in most major global territories. NCX 470 is also covered by granted composition of matter patents.
Gavin Spencer, Chief Business Officer at Nicox, said: “The granting of this formulation patent in China, in addition to the recent European and United States grants, further strengthens the protection around our lead product candidate, NCX 470, and allows our partner in China, Ocumension Therapeutics, to benefit from a significantly longer period of exclusivity while securing Nicox’s royalty stream on sales in China. Our Phase 3 clinical trials, Mont Blanc and Denali, continue to advance and we look forward to the submission of New Drug Applications in both the United States and China to bring NCX 470 to patients in these important markets.”
NCX 470, Nicox’s lead product candidate, is a novel nitric oxide (NO)-donating prostaglandin analog designed to release bimatoprost and NO into the eye. NCX 470 is currently being evaluated against latanoprost, the leading prostaglandin analog by prescription volume in the U.S., in the ongoing Mont Blanc and Denali Phase 3 clinical trials, with results expected in Q1 2023 and by the end of 2023, respectively.
Nicox has licensed exclusive rights to Ocumension for NCX 470 in China, Korea and Southeast Asia. Ocumension has paid €18 million to Nicox for these rights, and is also funding 50% of the total cost for the Denali Phase 3 clinical trial. Nicox stands to receive tiered royalties of between 6% and 12% on sales of NCX 470 by Ocumension. Ocumension is a Chinese ophthalmology company listed on the Hong Kong stock exchange since July 2020 (HKEX: OCUMENSION-B (1477)).About NCX 470NCX 470 is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog monotherapy 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 2020, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $24.3 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 NicoxNicox 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 nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also developing NCX 4251, a proprietary formulation of fluticasone, for dry eye disease. 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 C: 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 Dylan van Haaften Paris, France
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Damien Choplain Paris, France 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
Investor & Media
United States & Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
svonderweid@lifesciadvisors.comForward-Looking StatementsThe 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 2020’ filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 and in the 2nd chapter of the amendment to the “Document d’Enregistrement Universel, rapport financier annuel et rapport de gestion 2020” filed with the AMF on December 9, 2021 which are available on Nicox’s website (www.nicox.com).Nicox S.A.
Drakkar 2
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CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99
