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Johnson & Johnson will be purchasing all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system disorders, for $132.00 per share in cash, in a deal valued at 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 CEO, 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.”
With this agreement, Johnson & Johnson adds Intra-Cellular Therapies’ Caplyta (lumateperone), which is once-daily oral therapy that’s FDA-approved to treat adults with schizophrenia, along with depressive episodes that are connected to bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive treatment with lithium or valproate.
The acquisition also includes ITI-1284, a Phase II compound that is currently being analyzed in Alzheimer’s disease-related psychosis and agitation along with generalized anxiety disorder (GAD),2 as well as a clinical-stage pipeline that further supplements and J&J’s focus area.
“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson,” commented Jennifer Taubert, executive vice president and worldwide chairman of innovative medicine, 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.”
In December of last year, Intra-Cellular Therapies submitted a supplemental new drug application (sNDA) to the FDA for Caplyta as an additional treatment for adults with major depressive disorder (MDD).3 In fact, two global, double-blind, placebo-controlled Phase III studies demonstrated Caplyta to provide a statistically significant improvement in depressive symptoms, per the standards of clinician-rated and patient-reported outcomes.
There are also ongoing Caplyta Phase III trials surrounding bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania). Positive results measuring the efficacy and safety of the drug for the prevention of relapse in adult patients with schizophrenia were shared in November 2024.4
“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,” commented Dr. Sharon Mates, 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.”
References
1. Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Johnson & Johnson. 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
2. Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales Guidance. Intra-Cellular Therapies. August 7, 2024. Accessed January 13, 2025. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-reports-second-quarter-2024-financial
3. Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy. Intra-Cellular Therapies. December 3, 2024. Accessed January 13, 2025. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-submits-supplemental-new-drug
4. Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. Intra-Cellular Therapies. November 5, 2024. Accessed January 13, 2025. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-positive-topline-results-2