Nicox European Patent Seals Zerviate Major Market Coverage to 2030

Nicox announced that patent EP2408453, covering the company’s product Zerviate (cetirizine ophthalmic solution) 0.24%, has been issued by the European Patent Office (EPO). The patent covers the formulation of Zerviate which is commercialized in the US by exclusive US licensee Eyevance Pharmaceuticals, and its use in the treatment of the symptoms of allergic conjunctivitis or allergic rhinoconjunctivitis. The prescription market for allergic conjunctivitis products in Europe, Eastern Europe and Turkey was estimated by IQVIA as around €260 million in 2020. The European Patent grants exclusivity until 2030, meaning that the Zerviate formulation is protected by granted patents in the U.S. to 2032, and in Europe, Japan and Canada to 2030.

“The European patent grant means that Zerviate now has patent coverage in all the principal pharmaceutical markets worldwide. We are working with our existing partners to bring Zerviate to commercialization and continue to look for additional licensing opportunities to broaden the Zerviate franchise,” Gavin Spencer, Chief Business Officer of Nicox, said in a company news release. “The data package from the U.S. New Drug Application facilitates further approvals of Zerviate. We also collaborate with partners to ensure any necessary additional regulatory data are generated. In China, where Zerviate is partnered with Ocumension Therapeutics, for instance, pivotal Phase 3 data is being gathered to support local regulatory approval.”

Zerviate is commercialized in the US by exclusive U.S. partner Eyevance Pharmaceuticals, a wholly-owned subsidiary of Santen Pharmaceutical Co., of Japan. Zerviate is also exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets, to Samil Pharmaceutical in South Korea, to ITROM Pharmaceutical Group in certain Gulf and Arab markets, and to Laboratorios Grin in Mexico.