Nicox Estimates Potential Annual Global Net Sales for NCX 470 of Over $300 Million

Nicox SA said it that annual global net sales of NCX 470 could be over $300 million within 8 years of the date of launches in the U.S. and China. The estimate was based on a US market survey evaluating the commercial potential of NCX 470, a nitric oxide (NO)-donating bimatoprost, in development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and estimated potential global annual net sales for NCX 470.

“We recently conducted a market survey with a leading, independent research agency in the United States which confirmed the interest from ophthalmologists and optometrists in the potential use of NCX 470 as a therapeutic option for patients who do not reach their target intraocular pressure. The research also informed our potential pricing and reimbursement strategies, which we have factored into our assessment of the potential sales,” Andreas Segerros, CEO of Nicox, said in a company news release. “Based on this data, and insights from our Chinese and Southeast Asian partner, Ocumension Therapeutics, together with estimates of sales in other territories, we believe that annual global net sales of NCX 470 could be over $300 million within 8 years of the date of launches in the U.S. and China.

NCX 470, a novel 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[1]. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics.

NCX 470 is protected worldwide by patents until 2029, with potential extension of up to 5 years in the U.S. and Europe, and by formulation patents to 2039 in the U.S., EU, Japan and China as well as other territories.

The primary market research in the U.S. assumed NCX 470 obtained U.S. FDA approval with the safety and efficacy profile seen in the Mont Blanc phase 3 trial. The research involved ophthalmology key opinion leaders, prescribers and payors in a qualitative phase, followed by 100 glaucoma prescribers in a quantitative internet survey.

Reference

1 This date is based on projections of increased recruitment which take notably into account the lifting of COVID-19 restrictions in China.