First approval for placing on the market in the United States for Nicox
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First formulation for topical ocular of the antihistamine cetirizine
Covered by patents in the United States until at least 2030
Discussions underway for a license of marketing rights in the United States
May 31, 2017 – broadcast at 15: 00
Sophia Antipolis, France
Nicox (Euronext Paris : FR0013018124, COX, eligible PEA-PME), international society for R&D specialized in ophthalmology, announces today the approval by the american FDA (Food and Drug Administration) of the request for authorisation of the placing on the market in the United States (New Drug Application, NDA) for ZERVIATE (ophthalmic solution cetirizine for 0.24%; previously AC-170), the first formulation of topical ocular of this well known antihistamine for the treatment of ocular pruritus associated with allergic conjunctivitis.
The approval of the ZERVIATE by the FDA is a significant milestone for Nicox and discussions of partnership are underway for the license of marketing rights in the United States, commented Michele Garufi, ceo of Nicox. We expect to strengthen the position of our company R&D leader in the field of ophthalmology with the decision of the FDA to Vyzulta, licensed product worldwide to Bausch + Lomb and on the other hand the project of launch of phase 2 clinical studies for NCX 4251 and NCX 470. This is a very exciting time for the company and we will keep you informed of our progress.
After discussion with the AMF, the Company has requested the suspension of the share price Nicox today may 31, 2017. The listing should resume shortly after the dissemination of the press release.
About Nicox
Nicox is an international company in Research & Development specializing in ophthalmology using scientific technologies innovative to keep the vision and improve eye health. Drawing on its expertise is exclusive in terms of release of nitric oxide, and other technologies, the Company develops a broad portfolio of new therapeutic products targeting multiple ocular pathologies, including glaucoma. The company currently has a product whose placing on the market has been approved by the Food and Drug Administration (FDA) and one product at the stage prior to approval by the FDA and a portfolio of promising products, including nitric oxide-donating pure new generation, with the potential to treat various indications ophthalmic. Nicox is headquartered in Sophia Antipolis (France), is listed on Euronext Paris (Compartment B : Mid Caps ; Mnémo : COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150.
For more information on the Company : www.nicox.com
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