CMPA impacts up to 2-3% of infants and young children, and Nestlé says that it is difficult to diagnose.
French company DBV’s patch-test will enable early and accurate diagnosis of the condition, leading to early nutritional intervention, which Nestlé says is a strong fit with its Althéra, Alfaré and Alfamino products for babies and children with food allergies and intolerances.
Upfront payment for development
Under the terms of the agreement, DBV will be eligible to receive up to €100m ($111.4m) in development, registration and commercial milestones, including an upfront payment of €10m ($11.1m).
DBV will pay all development-related costs of MAG1C, including a worldwide clinical program, as well as manufacturing costs. If MAG1C is successfully manufactured, the company will receive a supply price with a mark-up from Nestlé Health Science.
In addition, Nestlé Health Science will pay DBV tiered royalties on global product sales.
Looking for 2021 approval
Greg Behar, CEO of Nestlé Health Science, said that the tool can become a breakthrough diagnostic for CMPA.
“Early diagnosis and nutritional intervention helps get infants happily back on the path of healthy development, alleviate the anxieties of parents, and reduce healthcare costs,” Behar said.
DBV’s food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases.
The new diagnostic test is expected to be submitted for approval to regulatory authorities worldwide by 2021.