Biopharmaceutical company Newron Pharmaceuticals S.p.A. (SIX: NWRN) (XETRA: NP5) and EA Pharma, a subsidiary of Eisai Co, Ltd, on Friday announced a licensing agreement for the development, manufacture and commercialisation of evenamide in Japan and other Asian territories.

Under the deal, Newron will receive up to EUR117m, including an upfront payment of EUR44m, milestone payments, and up to double-digit tiered royalties on net sales.

Evenamide, a novel glutamate modulator, targets treatment-resistant schizophrenia (TRS) and patients with poor response to current antipsychotics. Pivotal Phase III trials for evenamide as an add-on therapy are set to begin in the first half of 2025, involving over 600 TRS patients. Prior studies, including the Phase II 014/015 and Phase III 008A trials, demonstrated significant efficacy and a strong safety profile, validating evenamide as the first glutamate modulator to show efficacy in this patient group.

Schizophrenia affects approximately 25 million people worldwide, with 30-50% classified as treatment-resistant. Current therapies largely target dopaminergic systems, leaving a substantial unmet need for mechanisms addressing glutamatergic abnormalities, which are prevalent in TRS.

This agreement underscores Newron's commitment to advancing evenamide's development globally and positions EA Pharma to expand its portfolio in addressing central nervous system disorders. The upfront payment is expected to significantly impact Newron's 2024 financial performance.