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Nicox SA, an international ophthalmology company, announced the signing of a major new agreement concerning NCX 470 with Kowa Company, Ltd., a Japanese company with a global pharmaceutical business engaged in ground-breaking research, development and marketing. The agreement, worth up to €191.5 million, grants Kowa exclusive 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 in the US and all other territories of the world excluding Japan, China, Korea and Southeast Asia. Kowa already has a license to NCX 470 for Japan, where it is preparing to enter a phase 3 clinical trial. NCX 470 is also licensed to Ocumension Therapeutics for China, Korea and Southeast Asia.
Under the terms of the agreement, Nicox will receive an upfront payment of €7.5 million on signing. Additional near-term milestones payments are due on positive topline results from the Denali clinical trial, expected mid-August to mid-September 2025, and on submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA), which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial, plus royalties up to 20% in the US.
“This new agreement with our existing partner, Kowa, is a major endorsement of NCX 470’s potential in glaucoma and marks a major step forward in strengthening Nicox’s financial position. With NCX 470 now globally licensed, we are focused on delivering the Denali phase 3 results, which we anticipate releasing mid-August to mid-September.” said Gavin Spencer, chief executive officer of Nicox. “The revenue stream we expect from NCX 470 gives us the flexibility to pursue future growth opportunities, leveraging our expert US ophthalmology development team.”
“Expanding our collaboration with Kowa, who now becomes our key commercial partner for NCX 470 in the US and other major territories, is based on a very successful history of working together. We believe that Kowa has recognised the significant market potential of NCX 470, which we expect to be confirmed with the upcoming results from the Denali phase 3 trial.” said Emmet Purtill, VP business development of Nicox. “We look forward to continuing to work with Kowa as well as our partner for the Chinese market, Ocumension, to bring NCX 470 to glaucoma patients worldwide.”
Under the terms of the exclusive licensing agreement, Kowa is granted rights to develop and commercialize NCX 470 worldwide, excluding the territories already licensed to Ocumension (China, Korea and Southeast Asia) and to Kowa itself (Japan). The collaboration will be managed by a Joint Steering Committee. Key terms include:
Milestone payments -- Nicox will receive an upfront payment of €7.5 million upon signing the agreement. Additional near-term milestones payments are due on positive topline results from the Denali phase 3 clinical trial, expected mid-August to mid-September 2025 and upon submission of an NDA to the FDA, which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial.
Royalty payments -- Kowa will pay Nicox tiered royalties in the US which could reach 20% of net sales. Depending on the results of the Denali clinical trial, royalties due in the US will initially be 8% or 10%. Outside of the US, Nicox will receive tiered royalties ranging from single-digit to double-digit percentages.
Nicox obligations -- Nicox is responsible, at its cost, for generating the remaining development data necessary for the NDA submission to the FDA (principally pharmacokinetic studies) and will support Kowa in preparation of the NDA.
Kowa obligations -- Other than the activities for which Nicox is responsible, Kowa is responsible, at its cost, for all development, regulatory and commercialization activities for NCX 470 in the licensed territories.
Cash runway and debt repayment -- As disclosed in the amended bond agreement announced on 14 October 2024, 70% of the upfront payment from Kowa will be used to partially reimburse Nicox’s debt, reducing the total debt to €9.6 million. Based on the current cash position (estimated at €5.9 million as of 30 June 2025) expected revenue and anticipated milestone payments, Nicox forecasts that it has over 12 months of cash at the date of signature of this agreement.
Glaucoma pharmaceutical market -- The glaucoma pharmaceutical market is estimated at over $7 billion, with the US market accounting for around 40%, growing globally at around 3% to 5% CAGR and the number of patients globally is estimated to be around 80 million.
NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in phase 3 clinical development in the US, China and Japan (clinical trial authorisation granted for Japan) for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the phase 3 clinical trials, have been extensively published and are available on our website. The second phase 3 clinical trial, Denali, is currently ongoing. The last patient in Denali has completed their final visit, and the results are expected mid-August to mid-September 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy phase 3 trials to support NDA submissions in both the US and in China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the US NDA filing are on track. A separate phase 3 program is underway to support Japanese approval, with the first patient expected to be enrolled in H2 2025. NCX 470 is exclusively licensed to Ocumension Therapeutics in China, Korea and Southeast Asia, and to Kowa in the rest of the world.
Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead programme in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere.
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