Accelerates the ZERVIATE® approval and launch, which are expected in China in 2024 April 28, 2023 – release at 7:30 am CET
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the New Drug Application (NDA) for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24%, submitted in China by its exclusive Chinese partner, Ocumension Therapeutics, has been included in the priority review and approval process of National Medical Products Administration of the People’s Republic of China (“NMPA”). This will accelerate the approval process and potentially the launch of ZERVIATE in China. The priority review and approval process of NMPA is designed to expedite the approval of drugs that address unmet medical needs or have the potential to offer significant improvements over existing treatment options. The inclusion of ZERVIATE in the priority review and approval process of NMPA will accelerate the review and approval process of its new drug application, which is an important step towards commercialization of ZERVIATE. ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets. All costs of commercialization are borne by Ocumension and Nicox may potentially receive sales milestones of up to US$17.2 million together with royalties of between 5% and 9% of net sales of ZERVIATE by Ocumension. Ocumension’s Press Release can be found here.About NicoxNicox SA 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 bimatoprost, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company is also conducting research on NCX 1728, a nitric oxide-donating phosphodiesterase 5 inhibitor, in retinal conditions. NCX 4251, a novel, patented, ophthalmic suspension of fluticasone propionate nanocrystals for topical ocular application for dry eye disease, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available for partnering elsewhere. 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 (a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd.), in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, 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 Eric Yoo Paris, France
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Arsene Guekam 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 Executive Vice President, Chief Business Officer
& Head of Corporate Development
communications@nicox.com Forward-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 2021’ filed with the French Autorité des Marchés Financiers (AMF) on April 29, 2022 whose first amendment has been filed with the AMF on May 19, 2022, in the 2nd chapter of the second amendment filed with the AMF on November 22, 2022 and in the 2nd chapter of the Securities noted filed with the AMF on November 22, 2022 which are available on Nicox’s website (www.nicox.com)Nicox S.A. Bât D, 2405 route des Dolines
EN_ZERVIATE China NDA Fastrack PR_20230428