November 17, 2021– release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that patent EP 3,769,753, expiring in 2040 and covering the Company’s product candidate in development for blepharitis, NCX 4251, has been issued by the European Patent Office (EPO). The patent covers ophthalmic suspensions comprising a specific form of fluticasone propionate nanocrystals and the method for manufacturing the ophthalmic suspensions. Examination of corresponding patent applications providing exclusivity in the United States (U.S.), China, Japan and other territories is in process.
“The extension of patent coverage for NCX 4251 in the EU to 2040 is complementary to the patents we have covering our lead clinical candidate, NCX 470, granted up to 2039, ensuring that we should be able to realize substantial value from these product candidates for a significant exclusivity period following a potential future launch.” said Gavin Spencer, Chief Business Officer of Nicox. “Our commercialized assets are also well protected, with the granted U.S. patent on VYZULTA eligible for patent term extension in the United States, potentially to 2030, and ZERVIATE, covered to 2032, allowing for a sustained royalty stream up to, and in some countries, beyond, those dates.”
Patent Coverage of Clinical Product Candidates
NCX 470, our lead clinical candidate, an NO-donating prostaglandin analog, is covered worldwide by granted composition of matter patents to 2029, with potential extensions of the terms of the patents up to 5 years in the U.S. and EU, as well as formulation patents to 2039, granted in the U.S., EU and Japan and under examination in multiple other territories. NCX 470 is currently in two multi-regional Phase 3 trials for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. NCX 4251, a suspension of fluticasone propionate nanocrystals in development for blepharitis, is covered worldwide by granted patents to 2033, and to 2040 by the new EU patent announced today, which has corresponding patent applications submitted in the U.S. and other global territories.
Patent Coverage of Out-Licensed Commercialized Products VYZULTA®, (latanoprostene bunod ophthalmic solution), 0.024%, is covered worldwide by granted composition of matter patents to 2025, with eligibility for a patent term extension in the U.S. to potentially 2030 confirmed by the United States Patent and Trademark Office. VYZULTA is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension and is commercialized in the U.S. and multiple other countries by our exclusive global licensee, Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ZERVIATE® (cetirizine ophthalmic solution), 0.24%, is covered by granted formulation patents in the U.S. to 2032, Japan and Canada to 2030 and by a patent application for which the EPO issued a “Intention to Grant” communication. ZERVIATE is commercialized in the U.S. by our exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd of Japan. ZERVIATE is also exclusively licensed to Ocumension Therapeutics (Phase 3 ongoing) for development and commercialization in the Chinese and the majority of the South East Asian markets, to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico.
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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 nitric oxide-donating prostaglandin 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. |
Bryan, Garnier & Co Victor Floc’h Paris, France
Cantor Fitzgerald Louise Chen New York, U.S.
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Damien Choplain Paris, France
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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 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 which are available on Nicox’s website (www.nicox.com). |
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