Johnson & Johnson Boosts Neuroscience with Intra-Cellular Therapies Acquisition

Johnson & Johnson and Intra-Cellular Therapies, Inc. have announced a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies for $132.00 per share in cash, amounting to an equity value of approximately $14.6 billion. This acquisition is set to enhance Johnson & Johnson's portfolio in the field of central nervous system (CNS) disorders.

The acquisition includes CAPLYTA® (lumateperone), a significant addition to Johnson & Johnson's range of therapies. CAPLYTA® is the first and only U.S. FDA-approved treatment for bipolar I and II depression, suitable as both an adjunctive and monotherapy. It is also approved for adult schizophrenia treatment. The medication's success adds momentum to Johnson & Johnson’s sales growth, with potential peak year sales exceeding $5 billion. The acquisition strengthens the company's position to potentially surpass analyst expectations through the rest of the decade.

CAPLYTA® is not only approved for treatment but also undergoing further enhancement. A supplemental new drug application (sNDA) was submitted to the U.S. FDA for its use as an adjunctive treatment for major depressive disorder (MDD). If granted approval, CAPLYTA® may become a standard care treatment for common depressive disorders, marking the first advance in treating MDD and depressive symptoms associated with bipolar I and II in over 15 years.

Johnson & Johnson is also acquiring ITI-1284, a promising Phase 2 compound being studied for generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation. This fits well with their ongoing focus on neuropsychiatric and neurodegenerative disorders, adding depth to their clinical-stage pipeline.

Jennifer Taubert, Executive Vice President, highlighted the potential of this acquisition to significantly advance care for patients with neuropsychiatric and neurodegenerative disorders, enhancing the lives of millions globally. Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, expressed pride in the achievements of CAPLYTA® and looked forward to the benefits of joining forces with Johnson & Johnson to reach more patients worldwide.

In terms of safety and efficacy, CAPLYTA® has shown statistically significant improvements in depressive symptoms in clinical trials as an adjunctive therapy to antidepressants. Its safety profile has been consistent with existing clinical data, with the most common adverse effects being somnolence/sedation, dizziness, nausea, and dry mouth. Remarkably, it does not require dose titration, making it easier for patients to start treatment at effective doses.

The transaction is expected to be finalized later this year, subject to regulatory approvals and other standard conditions. Johnson & Johnson expects to fund the acquisition through cash and debt, maintaining a strong financial position to support its strategic priorities, including investments in research and development and shareholder returns.

Once completed, Intra-Cellular Therapies' common stock will be delisted from the Nasdaq Global Select Market. Johnson & Johnson plans to provide further details on the financial impact of this transaction during its fourth-quarter earnings call.

Through this acquisition, Johnson & Johnson aims to solidify its leadership in the mental health and CNS disorder treatment market, addressing the growing global need for effective therapies in the face of aging populations and rising mental health challenges.