Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan - Seite 2

The collaboration will be managed by a Joint Steering Committee. Kowa expects to conduct additional clinical trials in Japanese patients as required for regulatory approval of NCX 470 in Japan in addition to the development data from Nicox.

Nicox Corporate Status Update

Including the upfront payment from the Japanese licensing deal for NCX 470, the Company estimates it is currently funded until September 2024, exclusively based on the development of NCX 470. The Company is pursuing business development discussions which could further extend the cash runway, exploring multiple strategic options and is also discussing with its creditors to restructure its debt.

About NCX 470



NCX 470, a novel NO-donating bimatoprost eye drop, is currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, were announced in October 2022. The second Phase 3 clinical trial, Denali, is currently ongoing, and the results are expected in 2025, based on current recruitment rates. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics.   In addition to the Japanese and Chinese licensees for NCX 470, Nicox is also looking for a commercial partner in the United States.

NCX 470 is protected worldwide by a composition of matter patent until 2029, with potential extension of up to 5 years in the U.S. and Europe, and by a patent covering the eye drops formulation until 2039 in the U.S., EU, Japan and China as well as other territories. About Nicox 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 eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.