Nicox has broadened its partnership with Japan-based Kowa Company in a licensing deal worth up to €191.5 million ($224.7 million), handing Kowa exclusive rights to develop and commercialize its lead glaucoma candidate, NCX 470, across the US and most global markets.

Under the agreement, the French company will receive €7.5 million ($8.8 million) upfront and could earn milestone payments of upto €127 million ($149 million) or €191.5 million ($224.7 million), depending on the outcome of its ongoing Phase III Denali trial (NCT04630808). According to the company, “tiered royalties in the US could reach 20% of net sales”, with “high single- to double-digit royalties elsewhere”.

“This new agreement with Kowa underscores the potential of NCX 470 and marks an important step in strengthening Nicox’s financial footing,” Nicox’s CEO, Gavin Spencer, said in a statement. “We are now focused on delivering Denali’s Phase III results, expected by mid-September.”

Following the news, Nicox stock increased by as much as 60.6% during market trading on July 17, compared to the previous day’s close. Currently, the stock is up roughly 12.10% since the start of the year (2 January 2025).

Expanding Kowa’s Role

Kowa has previously licensed exclusive rights to the therapy in Japan as of February 2024. According to the licensing agreement, Kowa made an initial upfront payment of €3 million ($3.5 million) to Nicox. Additional milestone payments totaling €27.5 million ($32.3 million) are to be made based on further development, regulatory progress, and future sales in Japan. Furthermore, Nicox is eligible for tiered royalties ranging from 7% to 12%.

Importantly, the approval of the Clinical Trial Notification (the equivalent of the US IND in Japan) triggered a €1 million ($1.2 million) milestone payment. Another €2 million ($2.4 million) is expected when the Phase III trial begins in the second half of 2025.

Under the new expanded agreement, Kowa will take on the role of preparing and submitting the New Drug Application (NDA) to the US Food and Drug Administration (FDA), which is anticipated in the latter half of 2026. Additionally, it will oversee all subsequent development, regulatory, and commercialization efforts costs. Nicox will continue to generate certain remaining development data, including pharmacokinetic studies, to support the filing in the US.

For Nicox, the upfront cash will help reduce debt, with 70% allocated to partial repayment, trimming obligations to €9.6 million. As of June 30, the company reported a cash position of €5.9 million and expects over 12 months of runway.

The expanded partnership excludes China, Korea, and Southeast Asia, where rights are held by Ocumension Therapeutics. Ocumension paid €3 million in upfront payment for these rights, with Nicox being eligible to receive up to €33.25 million in milestone-based payment and 6%-12% in tiered royalties on sales, as per the 2018 agreement.

Glaucoma Market in Focus

NCX 470, a nitric oxide (NO)-donating bimatoprost eye drop, is designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Mont Blanc, the first Phase III trial (NCT04445519), has been completed and published. Denali, the second pivotal study, has finished patient visits, enrolling 696 patients. The topline results are due between mid-August and mid-September, with the NDA filing in the US expected in the first half of 2026. A separate Phase III program for Japan is expected to enroll its first patient in late 2025.

Nicox’s broader ophthalmology portfolio includes Vyzulta (latanoprostene bunod), licensed globally to Bausch + Lomb, and Zerviate (cetirizine ophthalmic), licensed in multiple countries for allergic conjunctivitis. Its preclinical program NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, is under development with Glaukos.

“Kowa’s willingness to expand its commitment signals confidence in NCX 470’s prospects ahead of critical data,” Emmet Purtill, VP of Business Development at Nicox, said. “We look forward to building on this partnership as we work to bring the therapy to patients worldwide.”