DBV Technologies said today it will partner with Nestlé Health Science to develop and commercialize a new diagnostic test for pediatric milk allergy, under a collaboration that could generate up to €100 million (about $112 million) for DBV.

The companies will work to create a ready-to-use, standardized atopy patch test for the diagnosis of cow's milk protein allergy (CMPA) in infants and toddlers, DBV said.

The diagnostic, called MAG1C, will apply DBV’s proprietary Viaskin® technology platform, which is based on epicutaneous immunotherapy (EPIT®), DBV's method of delivering biologically active compounds to the immune system through intact skin. That process sprays a liquid solution of electrically charged proteins onto the Viaskin patch’s backing, which is then turned into a dry, solid, charged particle that remains stuck onto the patch’s backing.

DBV agreed to oversee development of the new test through a Phase III clinical program, with Nestlé Health Science agreeing in return to support MAG1C’s worldwide commercialization through its nutritional solutions tailor-made for babies and young children suffering from CMPA and other food allergies and intolerances.

The wholly owned subsidiary of Nestlé agreed to pay DBV up to €100 million (about $112 million) tied to development, registration, and commercial milestones, including an upfront payment of €10 million ($11.2 million). DBV said it will pay for all development-related costs of MAG1C, including a worldwide clinical program, as well as manufacturing costs, while granting Nestlé Health Science global commercialization rights for MAG1C.

If MAG1C is successfully manufactured by DBV, the company will receive a supply price with a markup from Nestlé Health Science—which has also agreed to pay DBV tiered royalties on global product sales.

MAG1C is expected to be submitted for approval to regulatory authorities worldwide by 2021, according to DBV.

DBV’s food allergy efforts include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, as well as preclinical development of Viaskin Egg. DBV said it is also pursuing a human proof-of-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.

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