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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. 

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