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Newron Pharmaceuticals S.p.A., a biopharmaceutical company that develops therapies for diseases impacting the central and peripheral nervous system, and Myung In Pharm Co. Ltd., a CNS specialist pharma company in South Korea, are partnering up to develop, manufacture, and commercialize Newron’s modulator of the excessive release of glutamate known as evenamide, as an add-on therapy for both treatment-resistant schizophrenia (TRS) and patients that are poorly responding to schizophrenia, in South Korea.1
In exchange for an undisclosed upfront payment, milestone payments for development and regulatory achievements that are accomplished, and royalties on net sales, Myung In Pharm is expected to provide 10% of the total patient population that will join Newron’s upcoming Phase III trial, while also financially funding any costs related to this specific group. Furthermore, the company will handle all registration, marketing, regulatory, and commercialization costs for evenamide in South Korea and assume a decided percentage of eligible global development costs.
The aforementioned, one-year-long Phase III trial is expected to begin the first half of this year, and will be randomized and double-blind. It intends to compare evenamide to placebo as an add-on treatment in at least 600 patients with TRS. As alluded to earlier, Newron will be handling all trial logistics, by supervising the trial design, execution, and data analysis.
Myung In Pharm will be responsible for patient enrollment, and will utilize its network of clinical sites to help do so; the company will also assist in monitoring and data collection efforts.
“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,” commented Stefan Weber, Newron’s CEO. “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.”
As executives from both parties have noted, this agreement is primarily powered by patients, and the interest to improve their lives to the best of their ability.
“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,” expalined Hang Myung LEE, chairman, Myung In Pharm. “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.”
Aside from South Korea, Newron is also pursuing development opportunities in other countries. Last month, the company and EA Pharma reached a licensing deal for evenamide in Japan and other Asian territories.2
“EA is thrilled to acquire the license for evenamide in Japan and other Asian territories. Evenamide has a new mechanism of action involving glutamate regulation … It is the result of many years of outstanding research by the Newron team, ”said Hidenori Yabune, president of EA Pharma. “We believe evenamide has the potential to be transformational for patients suffering from schizophrenia.”
References
1. Newron and Myung In Pharm Announce License Agreement for evenamide in South Korea. Business Wire. January 9, 2025. Accessed January 14, 2025. https://www.businesswire.com/news/home/20250109233767/en/Newron-and-Myung-In-Pharm-Announce-License-Agreement-for-evenamide-in-South-Korea
2. Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announce license agreement for evenamide in Japan and other Asian territories. Newron Pharmaceuticals. December 13, 2024. Accessed January 14, 2025. https://www.newron.com/news-and-media/regulatory-news/newron-and-ea-pharma-subsidiary-eisai-co-ltd-announce-license