Johnson & Johnson Acquires Intra-Cellular Therapies to Bolster Mental Health Business

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Johnson & Johnson (J&J) announced that it has acquired Intra-Cellular Therapies, a biopharmaceutical company. According to the company, the acquisition includes Caplyta (lumateperone), a once-daily oral therapy approved for schizophrenia and bipolar depression. Currently, Caplya is under review for a new indication as adjunctive therapy for major depressive disorder (MDD). The acquisition also includes ITI-1284, a treatment that is currently in a Phase II trial for generalized anxiety disorder (GAD) and Alzheimer-related psychosis.¹

“Building on our nearly 70-year legacy in neuroscience, this unique opportunity to add Intra-Cellular Therapies to our Innovative Medicine business demonstrates our commitment to transforming care and advancing research in some of today’s most devastating neuropsychiatric and neurodegenerative disorders,” said Joaquin Duato, chairman, CEO, Johnson & Johnson, in a press release. “This acquisition further differentiates our portfolio, serves as a strategic near- and long-term growth catalyst for Johnson & Johnson and offers compelling value to patients, health systems and shareholders.”

Under terms of the deal, J&J will pay $132 a share, equal to an approximate total of $14.6 billion. J&J intends to complete the transaction through the use of cash on hand and debt. Closing of the transaction is expected later in the year pending applicable regulatory approvals and other customary closing conditions.

Results from two double-blind, placebo-controlled Phase III trials found that Caplyta demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms. Additionally, the treatment’s safety profile was consistent with previous findings, with no new safety signals identified. Common adverse events (AEs) included pruritus, rash, and urticaria.

J&J warned that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Currently, Caplyta isn’t approved for this indication. Additionally, it is recommended that patients treated with antidepressants should be evaluated for increased suicidal thoughts or behaviors. Further, Caplyta is contraindicated in patients with hypersensitivity to lumateperone or any ingredients in it.

The company also warned that antipsychotic drugs can also cause neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, falls, decreased blood pressure and dizziness, seizures, body temperature dysregulation, and other AEs.

“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson,” said Jennifer Taubert, EVP, worldwide chairman, Innovative Medicine, Johnson & Johnson, in the press release. “Together, we have an opportunity to impact even more patients living with neuropsychiatric and neurodegenerative disorders, significantly advancing care and helping improve the lives of millions worldwide.”

J&J also stated that currently, an estimated one billion people are living with a neuropsychiatric or neurodegenerative disorder globally. In the United States, an estimated 2.4 million people are living with schizophrenia, 6.1 million adults are living with bipolar disorder, 21 million adults live with MDD, 6.8 million live with GAD, and around 6 million adults live with Alzheimer’s disease.

“Caplyta has robust efficacy, proven safety and favorable tolerability across all three approved indications, without the need for dose titration frequently associated with this class of therapies,” said John Reed, MD, PhD, EVP, R&D, Innovative Medicine, Johnson & Johnson, in the press release. “With positive Phase III data in MDD as an adjunctive therapy and additional Phase III trials in other mental health disorders underway, we believe Caplyta has the potential to become a new standard of care for the treatment of some of today’s most prevalent and debilitating mental health disorders.”

Reference

1. Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. J&J. January 13, 2025. Accessed January 13, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-strengthens-neuroscience-leadership-with-acquisition-of-intra-cellular-therapies-inc