Newron and Myung In Pharm Collaborate on Evenamide Development

Newron and Myung In Pharm Forge Strategic Alliance

MILAN, Italy & MORRISTOWN, New Jersey & SEOUL, Republic of Korea-- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5) has partnered with Myung In Pharm Co. Ltd. (“Myung In Pharm”), South Korea’s premier CNS-focused pharmaceutical company, to develop and commercialize evenamide. This innovative therapy is aimed at treating patients with treatment-resistant schizophrenia (TRS) and those who do not respond well to existing schizophrenia treatments.

Collaboration Details and Responsibilities

The strategic agreement outlines that Myung In Pharm will engage in a pivotal Phase III trial, contributing 10% of the expected patient enrollment. Myung In Pharm aims to leverage its robust clinical infrastructure and CNS expertise to ensure successful patient recruitment and data management during the trial.

Financial Arrangements

According to the agreement, Myung In Pharm will also be responsible for a portion of the global development costs associated with evenamide. This collaboration is not only beneficial for achieving development milestones but also includes an upfront payment to Newron, which will also receive milestone payments based on regulatory achievements and will earn royalties based on net sales of evenamide in South Korea.

Study Overview and Goals

The upcoming Phase III trial is set to commence in the first half of 2025, targeting a participant base of at least 600 patients suffering from TRS. Newron will lead the trial, overseeing everything from study design to execution. Myung In Pharm’s clinical network will be vital for successful patient enrollment and monitoring throughout the study.

Future Development Plans

In addition to the collaboration with Myung In Pharm, Newron is exploring further opportunities for evenamide outside of South Korea. The company has recently formed another partnership to expand evenamide's market potential in Japan and other Asian territories.

Insights from Leadership

Stefan Weber, CEO of Newron, expressed excitement about the partnership, stating, "We are thrilled to partner with Myung In Pharm in this important clinical trial and to grant them the rights to develop, manufacture and commercialize evenamide in South Korea. Their strong expertise in CNS therapies will be instrumental in advancing evenamide's development."

Similarly, Hang Myung LEE, Chairman of Myung In Pharm, remarked, "We believe our participation will significantly contribute to the success of the study, aligning with our commitment to improving patient outcomes in the CNS area. This partnership presents a valuable opportunity to launch a new treatment for patients in South Korea."

Understanding Schizophrenia and Treatment Challenges

Schizophrenia affects millions globally, with an estimated 210,000 cases in South Korea alone. While numerous antipsychotic medications are prescribed, many patients exhibit treatment resistance, with 30-50% not responding to available therapies. The need for new treatment mechanisms, particularly targeting glutamatergic systems, has become increasingly critical.

The Role of Evenamide in Treatment

Evenamide stands out as a novel chemical entity that has shown promise in treating individuals with chronic schizophrenia in previous trials. Its clinical significance is underpinned by demonstrating efficacy alongside second-generation antipsychotics. Such an innovative approach might pave the way for overcoming treatment resistance in a substantial patient demographic.

About Newron Pharmaceuticals

Newron is a pioneering biopharmaceutical entity dedicated to developing advanced therapies for a range of CNS and peripheral nervous system disorders. Its headquarters are located near Milan, Italy. Additionally, Newron’s drug Xadago® has a wide market presence across several regions worldwide through its various partners.

About Myung In Pharm

Founded in 1985 and headquartered in Seoul, Myung In Pharm has established itself as a leader in CNS pharmaceuticals in South Korea. Their innovative manufacturing and dedication to neuroscience are complemented by collaborations with a vast network of healthcare professionals across the nation.

Frequently Asked Questions

What is the purpose of the collaboration between Newron and Myung In Pharm?

The partnership aims to develop and commercialize evenamide, a treatment for schizophrenia, particularly for patients who have treatment-resistant conditions.

What will Myung In Pharm's role be in the clinical trial?

Myung In Pharm will handle a portion of patient enrollments, leveraging its extensive clinical infrastructure to support the trial's execution.

When is the Phase III trial expected to begin?

The Phase III trial is slated to start in the first half of 2025.

What is unique about evenamide as a treatment option?

Evenamide is distinguished as a new approach in addressing treatment-resistant schizophrenia, showcasing a significant potential for improving patient outcomes compared to existing therapies.

How does Newron Pharmaceuticals contribute to the study?

Newron is responsible for the overall trial design, execution, and analysis of the data collected during the study, ensuring robust scientific outcomes.

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