Otsuka grows in neuroplastogens with $1.225bn Transcend buy

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Japanese pharma group Otsuka has agreed to acquire Transcend Therapeutics and its MDMA-based drug candidate for post-traumatic stress disorder (PTSD) and other psychiatric conditions for $700 million upfront.

The deal includes another $525 million in possible milestone payments if lead drug TSND-201 (methylone) meets certain sales objectives. Transcend is specialised in developing neuroplastogens – next-generation, non-hallucinogenic psychedelic therapies that can help the brain reorganise its structure and neural connections.

Research has shown that changes in neuroplasticity in the brain are deeply involved in both the onset and persistence of PTSD symptoms, said Otsuka.

In February, a placebo-controlled, phase 2 trial of TSND-201 in adults with severe PTSD was published in the journal JAMA Psychiatry, demonstrating significant improvements in symptoms at 64 weeks after four, once-weekly oral doses of Transcend's drug.

The company has been working on a phase 3 clinical programme for the neuroplastogen, which has been awarded breakthrough status from the FDA. In the US, more than 13 million people are estimated to be affected by PTSD each year, with no new treatments approved for 25 years.

TSND-201 promotes the release of monoamine neurotransmitters like serotonin (5-HT), norepinephrine, and dopamine in the brain, but has no activity at the 5-HT2A receptor, which is responsible for hallucinogenic effects.

Psychiatric and neurology is one of Otsuka's core therapeutic specialities, and the company has been working in the neuroplastogen and psychedelic space for some time, and Transcend will be its second recent acquisition in the category after buying Canada's Mindset Pharma for around $65 million in 2024.

The Mindset deal initially focused on MSP-1014, a psilocybin prodrug for treatment-resistant depression, although that doesn't feature in Otsuka's most recent pipeline listing, which lists follow-up 5-HT2A agonist MSP-2020 as the lead candidate sourced from Mindset, currently in phase 1.

The Transcend deal, which is expected to close in the second quarter of this year, would give Otsuka another shot on goal in PTSD after an FDA advisory committee concluded last year that its Lundbeck-partnered antidepressant Rexulti (brexpiprazole) had not shown efficacy in PTSD and voted against approval for that indication.

"Although treatment options for PTSD remain limited, TSND‑201 is generating expectations as a potential paradigm‑shifting therapy in the field of psychiatry," said Otsuka president Makoto Inoue.

"By combining Otsuka's long‑standing expertise in the psychiatric and neurological fields with Transcend's innovative approach, we will advance the development of TSND-201 in close collaboration with regulatory authorities to bring this new treatment option to patients."

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