World News: 06:31 GMT Friday 15th March 2019. [NICOX via Globe Newswire via SPi World News]
Nicox signs agreement for ZERVIATE in China for up to €17 million in milestone payments plus royalties
Ocumension will receive exclusive rights for the agreed territory to develop and commercialize ZERVIATE. Under the terms of the agreement, Nicox may potentially receive development and sales milestones of up €17 million together with royalties of between 5% and 9% on sales of ZERVIATE.
Ocumension is expected to have to conduct additional clinical studies for the regulatory approval of ZERVIATE in the Chinese market. All development activities will be overseen by a Joint Development Committee comprising representatives of both companies, with Ocumension responsible for undertaking all the activities at its own cost.
ZERVIATE (cetirizine ophthalmic solution), 0.24%, previously AC-170, is the first and only topical ocular formulation of the antihistamine cetirizine for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE is a novel formulation of cetirizine, the active ingredient in ZYRTEC, developed and approved for the first time for topical application in the eye. Cetirizine is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites. Cetirizine, in approved oral formulations, has a well-characterized systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use.
ZERVIATE is approved for commercialization in the U.S. where its commercial launch is planned in summer 2019 by Eyevance Pharmaceuticals LLC, our exclusive U.S. licensee.
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light. It is estimated that more than 75 million people suffer from allergic conjunctivitis in the U.S. and the estimated prevalence of allergic conjunctivitis may be between 15% and 40%.
Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. By leveraging our proprietary expertise in nitric oxide (NO) donation and other technologies, we are developing an extensive portfolio of novel product candidates that target multiple ophthalmic conditions, including glaucoma. Our portfolio includes three programs in development including NCX 470 for intraocular pressure lowering, based on our proprietary NO-donating research platform and NCX 4251, a proprietary formulation of the well-established molecule fluticasone, for acute exacerbations of blepharitis. Our research activities are focused on novel future generation NO-donors including NO-donating phosphodiesterase-5 (PDE5) inhibitors and NO-donating soluble guanylate cyclase (sGC) stimulators (in partnership with Ironwood). In addition, we have two ophthalmology assets that have been approved by the U.S. Food and Drug Administration (FDA); VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and commercialized in the U.S. by Bausch + Lomb since December 2017, as well as ZERVIATE(TM) (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: 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:
Bryan, Garnier & Co Hugo Solvet Paris, FranceH.C. Wainwright & Co Yi Chen New York, U.S.
Globe Newswire: 06:31 GMT Friday 15th March 2019
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