Newron and EA Pharma secure landmark licensing deal to advance schizophrenia treatment

In a move set to transform treatment options for patients with schizophrenia, Newron Pharmaceuticals S.p.A. (“Newron”) has entered into a high-value licensing agreement with EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. The deal grants EA Pharma exclusive rights to develop, manufacture, and commercialize evenamide, a novel drug targeting treatment-resistant schizophrenia (TRS), across Japan and select Asian territories.

This partnership positions evenamide as a promising solution for individuals who struggle with inadequate responses to current antipsychotic therapies.

What Does the Licensing Deal Include?

Under the agreement, Newron stands to receive up to €117 million through a combination of payments, including an upfront €44 million, milestone payments linked to regulatory approvals, and development and commercialization milestones. The contract also features double-digit tiered royalties on net sales, a significant financial boon for the biopharmaceutical company.

This substantial financial backing ensures Newron can continue advancing evenamide through global clinical trials while EA Pharma takes charge of regulatory and commercial operations in Asia.

Why Is Evenamide a Breakthrough in Schizophrenia Treatment?

Evenamide introduces a groundbreaking approach to managing treatment-resistant schizophrenia (TRS), which affects approximately 20–30% of individuals with schizophrenia who fail to respond to conventional antipsychotics. Unlike existing therapies, evenamide works as a novel glutamate modulator, regulating the excessive release of glutamate, a neurotransmitter linked to the underlying causes of TRS.

This unique mechanism has set evenamide apart in clinical trials, with results showing meaningful improvements in patients with chronic schizophrenia who previously exhibited poor responses to second-generation antipsychotics, including clozapine.

Clinical Trials Supporting Evenamide

The journey of evenamide has been supported by robust clinical data:

Phase II Open-Label Trial:

In a 2024 study, evenamide demonstrated significant clinical benefits when used as an add-on therapy for patients with TRS. Over 70% of participants experienced a clinically meaningful reduction in disease severity. Additionally, the drug was well-tolerated, with more than 90% of patients continuing into a long-term extension study.

Pivotal Phase III Trial (Study 008A):

Conducted with 291 participants, this randomized, double-blind, placebo-controlled study evaluated evenamide as an adjunct to existing antipsychotics. The trial met its primary endpoint, showing statistically significant improvements in Positive and Negative Syndrome Scale (PANSS) scores, a critical measure for schizophrenia severity. Secondary endpoints, such as the Clinical Global Impression (CGI-S) scale, also revealed meaningful benefits.

Importantly, evenamide exhibited a strong safety profile, with no increases in weight gain, metabolic syndrome, or sexual dysfunction – common side effects of many antipsychotics.

These findings validated evenamide as the first drug of its kind to effectively modulate glutamate and improve outcomes for patients inadequately responding to current treatments.

What’s Next for Evenamide?

Newron plans to initiate a Phase III randomized, double-blind, one-year trial in the first half of 2025. This pivotal study will involve over 600 participants and evaluate the drug as an add-on therapy for TRS. The trial will measure efficacy using changes in PANSS scores over 12 weeks and assess long-term safety and tolerability over 52 weeks.

With the EA Pharma licensing agreement, the development, regulatory submission, and eventual commercialization of evenamide in Japan and other designated Asian territories will be handled by the Japanese pharmaceutical company. Newron, meanwhile, will focus on advancing the drug in other global markets.

Industry Implications and Future Potential

The Newron-EA Pharma partnership highlights the growing demand for innovative solutions in mental health care, particularly for conditions like TRS that lack effective treatment options. With evenamide, patients in Japan and Asia could soon have access to a therapy that not only improves symptoms but also minimizes the side effects commonly associated with antipsychotics.

Stefan Weber, CEO of Newron, described the deal as a pivotal moment in the company’s journey, enabling evenamide to reach new markets and offering hope to patients who have exhausted existing options. Hidenori Yabune, President of EA Pharma, echoed these sentiments, emphasizing the drug’s potential to transform schizophrenia care through its novel mechanism of action.

About Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company headquartered in Bresso near Milan, Italy, focusing on innovative therapies for diseases of the central and peripheral nervous system. Alongside evenamide, Newron’s portfolio includes Xadago (safinamide), a globally approved treatment for Parkinson’s disease.