Newron and Myung In Pharm ink deal for evenamide development

Newron Pharmaceuticals and Myung In Pharm have entered into a licensing agreement to further the development, manufacturing, and commercialization of evenamide, a glutamate modulator designed as an add-on therapy for schizophrenia, specifically targeting treatment-resistant cases (TRS) and patients who exhibit a poor response to standard treatments. This agreement focuses on the South Korean market.

Evenamide is anticipated to be an important therapeutic addition for individuals suffering from treatment-resistant schizophrenia. The agreement outlines that Myung In Pharm will leverage its clinical infrastructure to support Newron’s forthcoming randomized Phase III clinical trial by enrolling 10% of the subjects, which equates to a minimum of 60 participants out of the 600 total. The South Korean pharmaceutical company will also cover the expenses related to these trial components.

Moreover, Myung In Pharm is tasked with handling the therapy's regulatory, registration, marketing, and commercialization processes within South Korea. It will support both the monitoring and data collection activities associated with the trial. In exchange for these contributions, Newron Pharmaceuticals is set to receive an upfront payment from Myung In Pharm, along with milestone payments and royalties based on net sales derived from the eventual commercial success of evenamide in South Korea.

The clinical trial itself is designed as a double-blind study lasting one year, wherein evenamide will be compared with a placebo to evaluate its efficacy as an add-on treatment. This trial is expected to launch in the first half of this year, with Newron assuming responsibility for the trial's execution, data analysis, and design. With this agreement in place, Newron is also exploring additional development opportunities for evenamide in other geographic regions.

Stefan Weber, CEO of Newron, expressed enthusiasm about the collaboration with Myung In Pharm, emphasizing the opportunity to develop, manufacture, and commercialize evenamide in South Korea. Myung In Pharm chairman Hang Myung LEE also conveyed confidence in the partnership, noting that Newron’s innovative strategies complement Myung In Pharm's dedication to enhancing patient outcomes in the central nervous system (CNS) domain. He believes that their participation will significantly contribute to the study's success.

In facilitating this agreement, Jefferies International acted as the exclusive financial adviser to Newron, while legal counsel was provided by Orrick Herrington & Sutcliffe. On the other side, Cosmo Group served as an adviser to Myung In Pharm.

This collaboration comes on the heels of a similar agreement announced last month between Newron and EA Pharma, a subsidiary of Eisai, aimed at licensing evenamide for use in Japan and other Asian regions. This strategic expansion underscores Newron’s commitment to addressing the challenges of treatment-resistant schizophrenia on a broader scale, leveraging partnerships to enhance therapeutic options for patients in diverse markets.