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January 2025

Newron and Myung In Pharm announce license agreement for evenamide in South Korea

Newron and Myung In Pharm announce license agreement for evenamide in South Korea

Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea
Myung In Pharm to contribute 10% of patients to Newron’s pivotal Phase III trial for evenamide, and share global development costs
Newron will receive upfront payment, development and regulatory milestones, and royalties on net sales
Newron expects to begin pivotal Phase III trial in H1 2025

Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system based within the OpenZone campus, and Myung In Pharm, South Korea’s leading central nervous system  (CNS) specialist pharmaceutical company, announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, an add-on therapy for treatment-resistant schizophrenia (TRS) and poorly responding patients with schizophrenia, in South Korea. 

Under the terms of the license agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming pivotal Phase III trial and cover the costs related to this population. Myung In Pharm’s involvement leverages its established clinical infrastructure and expertise in the central nervous system (CNS) field. Furthermore, the company will bear a percentage of eligible global development costs and will also be responsible for all regulatory, registration, marketing, and commercialization costs for evenamide in South Korea. In return, Newron will receive an upfront payment, milestone payments for development and regulatory achievements, and royalties on net sales. 
The Phase III randomized, double-blind, one-year trial is expected to begin in H1 2025 and will compare evenamide to placebo as an add-on treatment in at least 600 patients with  treatment-resistant schizophrenia (TRS). It will be coordinated by Newron, who will oversee the trial design, execution, and data analysis. Myung In Pharm will be responsible for enrolling patients in South Korea through its extensive network of clinical sites, as well as providing support with monitoring and data collection. Newron continues to pursue further development opportunities for evenamide in other territories. On December 13, 2024, Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announced a license agreement for evenamide in Japan and other Asian territories.

Stefan Weber, CEO of Newron

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 and their clinical infrastructure will be instrumental in advancing the development of evenamide. This collaboration underscores our shared commitment to transforming the treatment landscape for patients with unmet needs.


Hang Myung LEE, Chairman of Myung In Pharm

Newron’s innovative approach aligns with our commitment to improving patient outcomes in the CNS area, and we believe our participation will make a significant contribution to the success of the study. Furthermore, we are honored to have received the license to commercialize evenamide in South Korea. This partnership presents a valuable opportunity for us to bring a new treatment option to patients in South Korea, a key market for Myung In Pharm. We look forward to working closely with the Newron team to bring this promising therapeutic to the forefront of clinical development and expand its impact in South Korea.

 
 
Ravi Anand, M.D.
Newron’s Chief Medical Officer

 

New therapeutic options are desperately needed for treatment-resistant schizophrenia that occurs in approximately one third of patients. These results from studies 014/015 make us excited about the clinical potential of evenamide. The data comparing the impact of evenamide at six weeks versus six months, reported today, suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time. Confirmation in a controlled trial would support the hypothesis that evenamide treatment is associated with an attenuation of abnormal glutamate activity noted in patients with TRS.

 

Newron has submitted an abstract for the presentation of these latest results at the 31st European Congress of Psychiatry taking place March 25-28, 2023, in Paris, France.
 

The enrollment of study 014 has been completed with 161 subjects. Newron expects to announce the full results from the study in March 2023. The extension arm, study 015, is ongoing and will provide results of evenamide treatment for up to one year from the first 100 patients by Q2 2023.
 

Newron expects to initiate a potentially pivotal, multinational, randomized, ten-week, placebo-controlled study (003) in TRS patients in 2023, as part of its ongoing Phase II/III development plan for evenamide. The first potentially pivotal study of this development program, study 008A with evenamide as add-on therapy in patients with chronic schizophrenia experiencing inadequate response to their current antipsychotics (but not classed as having TRS), is continuing to enroll patients, and results are expected in 2023.

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