Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan
Nicox SA announced the signature of an agreement granting Kowa exclusive Japanese rights to develop and commercialize NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop for the lowering of IOP in patients with glaucoma or ocular hypertension.
Under the terms of the exclusive licensing agreement, Kowa will make a non-refundable upfront payment of €3 million ($3.23 million) to Nicox, with a further potential €10 million ($10.76 million) in development and regulatory milestones, €17.5 million ($18.82 million) in sales milestones and tiered royalties from 7% to 12% on net sales. Kowa will be responsible for all development, regulatory and commercialization costs for NCX 470 in Japan.
“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,” Emmet Purtill, Vice President of Business Development at Nicox, said in a company news release. “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.”
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.
Including the upfront payment from the Japanese licensing deal for NCX 470, Nicox 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, according to a company news release.
NCX 470, a 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.