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Newron Licenses Schizophrenia Treatment to EA Pharma

13.12.2024 - Italian drugmaker Newron Pharmaceuticals and EA Pharma, a subsidiary of Japan’s Eisai, today have entered into a license agreement to develop, manufacture and commercialize Newron’s evenamide in Japan and other designated Asian territories.

Evenamide is an innovative modulator of the excessive release of glutamate in treatment-resistant schizophrenia (TRS) and poorly responding patients with schizophrenia.

Under the terms of the agreement, Newron will receive up to €117 million from EA Pharma in exchange for full rights in the licensed territories. This includes an upfront payment of €44 million, contributions to the upcoming one-year Phase III study outside the licensed territories, regulatory and commercial milestones, and tiered royalties on net sales of evenamide up to a double-digit percentage.

The execution of this agreement, especially the upfront payment of €44 million, is expected to materially impact Newron’s 2024 financial statements.

Stefan Weber, CEO of Newron, commented: “This partnering agreement for evenamide is a key milestone in our goal to offer a truly innovative, evidence-based alternative to patients suffering from schizophrenia, those who are responding poorly to their treatments, or who have become treatment resistant to currently available medications. […] Newron will now focus on the initiation of our Phase III one-year study in TRS and expect to start that study outside of the licensed territories in H1 2025. We are also pursuing further development opportunities for evenamide in other territories.”

“Evenamide has a new mechanism of action involving glutamate regulation and is the first in the world with this mechanism of action to demonstrate therapeutic efficacy in clinical trials[…] We believe evenamide has the potential to be transformational for patients suffering from schizophrenia.” said Hidenori Yabune, president of EA Pharma.