Nicox to Receive €15 Million and Half of the Cost of the Second NCX 470 Phase 3 Clinical Trial from Ocumension Therapeutics under Amended Agreement
March 11, 2020
Ocumension will pay Nicox €15M
Ocumension will additionally fund half of the costs of a joint U.S.-Chinese Phase 3 clinical trial on NCX 470, expected to begin in H2 2020, after the start of the Mont Blanc Phase 3 clinical trial
Accelerates the NCX 470 development plans and New Drug Application (NDA) submissions in the U.S. and China
Ocumension rights to NCX 470 are extended to Korea and South East Asian markets
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has amended its December 2018 licence agreement with Ocumension Therapeutics, which originally granted Ocumension exclusive rights to develop and commercialize NCX 470 for glaucoma in the Chinese market. Under the amended agreement, Ocumension will immediately pay Nicox €15 million (in place of the milestones in the original agreement), will gain additional rights to NCX 470 for Korea and South East Asia and will pay 50% of the costs of the second glaucoma Phase 3 clinical trial of NCX 470 (‘Denali’). The two companies will jointly manage the Denali trial in the U.S. and China.
NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, is Nicox’s lead clinical development program. In the multicenter, Phase 2 clinical trial (‘Dolomites’) conducted in the U.S., NCX 470 demonstrated both statistical non-inferiority and superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions.
“We believe conducting the Denali Phase 3 trial together will allow both companies to more effectively achieve the development goals for NCX 470,” said Gavin Spencer, Chief Business Officer of Nicox. “Bringing forward the Ocumension milestone payments in this way is a major step in the financing of the U.S. and Chinese NCX 470 programs allowing us to initiate both Phase 3 clinical trials this year and accelerating the NDA submission of NCX 470 in the U.S. and Chinese markets.”
Ocumension is funded by top-tier venture capital investors including 6 Dimensions Capital and other distinguished investors. Ocumension recruited highly qualified management and development teams with significant international experience gained in companies including Santen, Alcon and Novartis. The Ocumension team has conducted ophthalmology clinical studies in China previously and has the personnel and infrastructure in place in China to effectively collaborate with Nicox on the Denali study.
“Executing one of the key clinical trials for NCX 470 in collaboration with Nicox is the best route for us to achieve approval in the Chinese market and therefore we are very pleased to be further strengthening our relationship with Nicox in this way. We look forward to even deeper collaboration between the teams as we prepare for this trial,” said Ye Liu, Chief Executive Officer of Ocumension.
As a result of the amendment, Nicox will conduct both of its planned Phase 3 clinical trials, Mont Blanc and Denali, as multi-regional clinical trials in U.S. and China. The two planned Phase 3 trials are required for NDA submission in the U.S. The inclusion of Chinese patients in the Denali trial is designed to support the NCX 470 NDA submission in China without further clinical trials in China. Including the €15 million payment from Ocumension, Nicox now has a cash position of approximately €47 million.
NCX 470 Phase 3 Clinical Trials Planned
- The first Phase 3 clinical trial on NCX 470 (‘Mont Blanc’) for lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension is due to start by the end of Q2 2020, with top-line results expected in Q3 2021. The Mont Blanc trial will be managed by Nicox and it will also include a small number of Chinese patients. The Mont Blanc trial will be initiated with 0.065% and 0.1% doses of NCX 470, with one dose being selected during the trial through an adaptive design.
- Nicox and Ocumension will jointly manage, and equally fund, a second glaucoma Phase 3 clinical trial with NCX 470 (‘Denali’) including clinical sites and patients in both the U.S. and China, with majority of the clinical sites and patients being in the U.S. A sufficient number of patients from China will be included in the Denali trial to support the NCX 470 NDA filing in China.
- The inclusion of the Chinese patients in the NCX 470 Phase 3 program was discussed and agreed on with the U.S. FDA during the recently reported End-of-Phase 2 meeting.
Amendment Agreement Terms
Under the 2018 agreement, Ocumension received exclusive rights to develop and commercialize NCX 470, at its own cost, in the Chinese market. Nicox received a one-time upfront payment of €3 million from Ocumension. Under the amended agreement, Ocumension will immediately pay Nicox €15 million and, furthermore, will fund 50% of the costs of the joint U.S.-China second Phase 3 clinical trial. No future NCX 470 milestones will be due from Ocumension to Nicox. In the unlikely case that the Joint Trial would not take place, refunds of some or the significant majority of this payment may be made and in certain situations the original milestones of the agreement would again apply.