Johnson & Johnson Acquired Intra-Cellular Therapies

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Johnson & Johnson today announced that they will acquire all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders, for approximately $14.6 billion.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 and chief executive officer of Johnson & Johnson. “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.”

Notably, with this acquisition, Johnson & Johnson gains Intra-Cellular Therapies’ lumateperone (Caplyta), a once-daily oral therapy approved to treat adults with schizophrenia, and depressive episodes associated with bipolar I or II disorder, as a monotherapy and adjunctive therapy with lithium or valproate.

“Caplyta’s success and the robust pipeline we have built demonstrates the passion and dedication of our talented team, and we are proud of the hundreds of thousands of patients we have helped,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. “Johnson & Johnson has a longstanding commitment to neuroscience, and we believe together, we can reach even more patients around the world.”

Intra-Cellular Therapies submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for Caplyta as an adjunctive treatment for adults with major depressive disorder (MDD) in December 2024.² Caplyta, added to antidepressant treatment, demonstrated robust efficacy for MDD in the primary endpoint, the Montgomery Asberg Depression Rating Scale (MADRS) total score, with a large separation vs placebo of 4.9 points (effect size 0.61) in study 501 and 4.5 points (effect size 0.56) vs placebo in study 502. Caplyta also demonstrated a favorable safety and tolerability profile, including a favorable metabolic, weight, and movement disorder profile. The most commonly reported adverse events in the pooled safety data for studies 501 and 502 that were observed at a rate greater than or equal to 5% for lumateperone and greater than twice the rate of placebo were dizziness, dry mouth, somnolence/sedation, nausea, and fatigue. If approved, Caplyta has the potential to be the first treatment approved for MDD and depressive symptoms associated with bipolar I and II in more than 15 years.

“Caplyta has robust efficacy, proven safety and favorable tolerability across all 3 approved indications, without the need for dose titration frequently associated with this class of therapies,” said John Reed, MD, PhD, executive vice president of research and development, Innovative Medicine at Johnson & Johnson. “With positive phase 3 data in MDD as an adjunctive therapy and additional phase 3 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.”

Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies for $132.00 per share in cash. The closing of the transaction is expected to occur later in 2025 subject to applicable regulatory approvals, approval by Intra-Cellular Therapies’ stockholders and other customary closing conditions for this type of transaction.

“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson,” said Jennifer Taubert, executive vice president and worldwide chairman of Innovative Medicine at Johnson & Johnson. “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.”

References

1. Johnson & Johnson strengthens neuroscience leadership with acquisition of Intra-Cellular Therapies, Inc. News release. January 13, 2025. https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnson-Strengthens-Neuroscience-Leadership-with-Acquisition-of-Intra-Cellular-Therapies-Inc/default.aspx

2. Kuntz L. sNDA submitted: Lumateperone as adjunctive therapy for major depressive disorder. Psychiatric Times. December 3, 2024. https://www.psychiatrictimes.com/view/snda-submitted-lumateperone-as-adjunctive-therapy-for-major-depressive-disorder