Nicox Inks Exclusive Agreement with Kowa for NCX 470 Development in Japan

Nicox SA announced an agreement with Kowa, granting the latter exclusive rights in Japan for the development and commercialization of NCX 470, a promising nitric oxide (NO)-donating bimatoprost eye drop designed for reducing intraocular pressure (IOP) in individuals with glaucoma or ocular hypertension.

The agreement entails an upfront payment of €3 million ($3.23 million) to Nicox, with potential additional payments amounting to €10 million ($10.76 million) in development and regulatory milestones, €17.5 million ($18.82 million) in sales milestones, and tiered royalties ranging from 7% to 12% on net sales. Furthermore, Kowa will shoulder all expenses related to the development, regulatory processes, and commercialization of NCX 470 in Japan.

In a statement, Emmet Purtill, Vice President of Business Development at Nicox, expressed enthusiasm about the partnership, saying, “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.”

Japan, being one of the largest regional markets for ophthalmic therapeutics, presents a significant opportunity for NCX 470. Purtill highlighted the potential global revenue, estimating it to exceed $300 million in peak annual net sales.

The collaboration will be governed by a joint steering committee, with Kowa expected to conduct additional clinical trials tailored to Japanese patients as part of the regulatory approval process for NCX 470 in Japan. Nicox's existing development data will complement these efforts.

The deal also fortifies Nicox's financial position, with the upfront payment extending its funding until September 2024, solely focusing on NCX 470 development. The company is actively engaged in business development discussions to further extend its cash runway and exploring strategic options. Discussions with creditors are also underway to restructure debt obligations, as indicated in a company news release.

NCX 470 is currently undergoing phase 3 clinical trials for lowering IOP in patients with open-angle glaucoma or ocular hypertension. The first phase 3 trial, Mont Blanc, yielded promising results in October 2022. The second trial, Denali, is presently ongoing, with results anticipated in 2025, based on current recruitment rates.