Nicox SA, an international ophthalmology company, announced the signature of an agreement granting Kowa Company, Ltd., a Japanese company with a global pharmaceutical business engaged in ground-breaking research, development and marketing, exclusive Japanese rights to develop and commercialize NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
“We are very pleased to welcome Kowa as an exclusive partner for our lead asset, NCX 470, for the Japanese market. The interest of such an established ophthalmology player confirms the scientific and commercial opportunity for NCX 470 specifically for Japanese patients.” said Emmet Purtill, vice president of business development at Nicox. “Japan represents one of the largest regional markets for ophthalmic therapeutics and therefore this collaboration significantly strengthens the global potential revenue for NCX 470, which we estimate to be over $300 million in peak annual net sales.”
Under the terms of the exclusive licensing agreement, Kowa has the rights to develop and commercialize NCX 470 in Japan. Kowa shall make a non-refundable upfront payment of €3 million to Nicox, with a further potential €10 million in development and regulatory milestones, €17.5 million in sales milestones and tiered royalties from 7% to 12% on net sales. Kowa shall be responsible for all development, regulatory and commercialization costs for NCX 470 in Japan.
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.
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 US 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 US and Europe, and by a patent covering the eye drops formulation until 2039 in the US, EU, Japan and China as well as other territories.
Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.
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