Nicox is Granted Patent for Blepharitis Product Candidate NCX 4251 in Europe

• Newly granted patent extends the patent coverage for NCX 4251 in EU to 2040
  • Application from the same patent family pending in the United States

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.