Nicox’s Partner Ocumension Therapeutics Receives Priority Review Status for ZERVIATE New Drug Application in China
Nicox’s partner, Ocumension Therapeutics, announced on April 26, 2023, that they had received Priority Review Status for the New Drug Application for ZERVIATE in China
Accelerates the ZERVIATE® approval and launch, which are expected in China in 2024
April 28, 2023 – release at 7:30 am CET
Sophia Antipolis, France
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.
ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost $500 million by 2030. Ocumension is forecasting potential annual net sales of ZERVIATE >$100 million within 7 years.
The ZERVIATE NDA in China is supported by the data package licensed by Nicox to Ocumension and an additional Chinese Phase 3 clinical trial of ZERVIATE run by Ocumension. ZERVIATE was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name EMADINE®. ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. ZERVIATE was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate.
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.
Nicox 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.
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
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