Johnson & Johnson (J&J) has announced a definitive agreement to acquire Intra-Cellular Therapies, Inc. (ITCI) for $14.6 billion, marking a significant expansion of J&J's neuroscience portfolio. The acquisition, expected to close in late 2025, will bring ITCI's key asset, Caplyta (lumateperone), into J&J's fold, along with a promising pipeline targeting various central nervous system (CNS) disorders.
Acquisition Details and Strategic Rationale
Under the terms of the agreement, J&J will acquire all outstanding shares of ITCI for $132.00 per share in cash. This move is projected to bolster J&J's Innovative Medicine business, providing both near- and long-term growth catalysts. Joaquin Duato, Chairman and CEO of Johnson & Johnson, emphasized the company's commitment to transforming care and advancing research in neuropsychiatric and neurodegenerative disorders through this acquisition.
Caplyta: A Key Asset in Schizophrenia and Bipolar Depression
Caplyta (lumateperone) is a once-daily oral therapy already approved by the U.S. FDA for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as a monotherapy and adjunctive therapy with lithium or valproate. According to J&J, Caplyta has the potential to generate over $5 billion in peak annual sales.
Notably, a supplemental New Drug Application (sNDA) has been submitted to the FDA for Caplyta as an adjunctive treatment for adults with major depressive disorder (MDD). Phase 3 trials have demonstrated statistically significant and clinically meaningful improvements in depressive symptoms when Caplyta is used alongside antidepressants. If approved, Caplyta could become a new standard of care for MDD and depressive symptoms associated with bipolar disorder.
Expanding the Pipeline: ITI-1284 and Beyond
In addition to Caplyta, the acquisition includes ITI-1284, a compound currently in Phase 2 trials for generalized anxiety disorder (GAD) and Alzheimer's disease-related psychosis and agitation. This addition strengthens J&J's pipeline and expands its focus on addressing a wider range of neuropsychiatric and neurodegenerative conditions.
Addressing Unmet Needs in Mental Health
The acquisition comes at a time when the prevalence of neuropsychiatric and neurodegenerative disorders is increasing globally. J&J estimates that over one billion people worldwide are affected by these conditions. In the United States alone:
- Approximately 2.4 million adults live with schizophrenia.
- Around 6.1 million adults have bipolar disorder.
- An estimated 21 million adults are affected by MDD.
- About 6.8 million adults live with GAD.
- Roughly 6 million adults have Alzheimer’s disease.
Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson, highlighted the opportunity to impact even more patients living with these disorders through the combined expertise of both companies.
Safety Profile and Considerations for Caplyta
Caplyta's prescribing information includes a boxed warning regarding the increased risk of death in elderly patients with dementia-related psychosis treated with antipsychotic drugs; Caplyta is not approved for this indication. Additionally, antidepressants can increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Common adverse events associated with Caplyta include somnolence/sedation, dizziness, nausea, and dry mouth.
Financial and Regulatory Aspects
J&J intends to fund the acquisition through a combination of cash on hand and debt. The closing of the transaction is subject to regulatory approvals, approval by ITCI's stockholders, and other customary closing conditions. Citi is serving as financial advisor to Johnson & Johnson, while Centerview Partners LLC and Jefferies are serving as financial advisors to Intra-Cellular Therapies.
