Newron Pharmaceuticals has secured 44 million euros ($46.1 million) in upfront cash from an Eisai subsidiary for select Asia rights to its add-on schizophrenia treatment.
When adding the upfront payment to potential development and commercialization milestones, the Italian biotech could be in line for a total of 117 million euros ($122.8 million) from Japan’s EA Pharma, along with tiered royalties up to a double-digit percentage of net sales.
In return, EA will get the license to develop, manufacture and commercialize evenamide in Japan and other designated Asian territories including Vietnam, Cambodia, Indonesia and the Philippines.
Evenamide, an innovative modulator of the excessive release of glutamate, was shown to improve both so-called positive and negative symptoms of schizophrenia when given as an add-on treatment to anti-psychotics like clozapine in a phase 2/3 study that read out in April.
At the time, Newron called the main endpoint results “highly statistically significant,” with patients on evenamide seeing a 10.2-point reduction on the Positive and Negative Syndrome Scale at Day 29, compared to 7.6 for the placebo group.
Newron CEO Stefan Weber said in today’s release that the deal with EA would offer an “opportunity to advance evenamide through a phase 3 study and towards regulatory submission in Japan and other Asian territories by one of Japan’s leading pharmaceutical companies.”
“Newron will now focus on the initiation of our phase 3 one-year study in treatment-resistant schizophrenia and expect to start that study outside of the licensed territories in H1 2025,” Weber added. “We are also pursuing further development opportunities for evenamide in other territories.”
The schizophrenia space received a shot in the arm this year when Bristol Myers Squibb secured FDA approval for KarXT—now dubbed Cobenfy—marking the first new drug for the mental health condition in decades.