Newron Pharmaceuticals and Myung In Pharm have signed a licence agreement to develop, manufacture, and commercialise the former’s glutamate modulator, evenamide, for schizophrenia in South Korea.

Evenamide is an add-on therapy intended for treatment-resistant schizophrenia (TRS) and for schizophrenia individuals who have poor response. 

Under the agreement, Myung In Pharma will use its clinical infrastructure and contribute 10% of the subjects to be enrolled for Newron’s upcoming randomised Phase III trial. It will also cover the associated expenses.

It will also be responsible for the therapy-related regulations, registration, marketing, and commercialisation expenses in the country and is set to support monitoring and data collection in the trial.

In return, Newron will obtain an upfront payment, milestone payments, and net sales royalties.

Its double-blind, one-year trial comparing the therapy with placebo as an add-on treatment is anticipated to commence in the first half of this year and will involve a minimum of 600 TRS subjects.

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Newron is responsible for the trial’s execution, data analysis, and design. The company is actively seeking additional development opportunities for the therapy in other regions.

Newron CEO Stefan Weber said: “We are thrilled to partner with Myung In Pharm in this important clinical trial and to grant them the rights to develop, manufacture, and commercialise evenamide in South Korea.”

Myung In Pharm chairman Hang Myung LEE said: “Newron’s innovative approach aligns with our commitment to improving patient outcomes in the CNS [central nervous system] area, and we believe our participation will make a significant contribution to the success of the study.”

Jefferies International served as the exclusive financial adviser, and Orrick Herrington & Sutcliffe provided legal counsel to Newron. Cosmo Group served as an adviser to Myung In Pharm.

Last month, Newron and Eisai subsidiary EA Pharma announced a licence agreement for the therapy in Japan and other Asian regions.