Johnson & Johnson and Intra-Cellular Therapies announced this week that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders for $132 per share in cash for a total equity value of approximately $14.6 billion.
With this deal, Johnson & Johnson adds Intra-Cellular Therapies’ CAPLYTA (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate.
This acquisition also includes ITI-1284, a promising Phase 2 compound being studied in generalized anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as a clinical-stage pipeline that further complements and strengthens Johnson & Johnson’s current areas of focus.
In December 2024, Intra-Cellular Therapies announced submitting a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA as an adjunctive treatment for adults with major depressive disorder (MDD). And in two global, double-blind, placebo-controlled Phase 3 studies, CAPLYTA, as an adjunctive treatment to antidepressants, showed a statistically significant and clinically meaningful improvement in depressive symptoms, as measured by both clinician-rated and patient-reported outcomes.
The safety profile of CAPLYTA in both studies was consistent with the existing body of clinical data for CAPLYTA, and no new safety concerns were identified. If approved, then 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. Plus, Phase 3 trials are underway with CAPLYTA in bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania). Positive topline results evaluating the efficacy and safety of CAPLYTA for the prevention of relapse in adult patients with schizophrenia were shared in November 2024.
Even though its exact mechanism of action is unknown, CAPLYTA is uniquely characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. And in short-term clinical studies across all three approved indications, CAPLYTA was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms – which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth, and across all three approved indications, CAPLYTA can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose.
With the mental health crisis surging, over one billion people worldwide are living with a neuropsychiatric or neurodegenerative disorder. In the United States:
— Over 2 million adults are estimated to live with schizophrenia, a serious, chronic mental illness that causes distortions in thinking, perceptions, emotions, and behavior
— Over 6 million adults are estimated to live with bipolar disorder, a chronic, lifelong illness that causes dramatic shifts in a person’s mood, energy, and ability to think clearly, making it difficult for patients to carry out daily activities
— Over 20 million adults are estimated to be living with MDD, which is one of the most common psychiatric disorders and a leading cause of disability
— Over 6 million adults are estimated to be living with GAD, a mental and behavioral disorder that causes excessive and uncontrollable worry and fear
— About 6 million adults live with Alzheimer’s disease, a neurodegenerative brain disorder that causes progressive memory loss and a decline in cognitive abilities severe enough to interfere with daily life significantly.
The transaction’s closing is expected to happen later this year, subject to applicable regulatory approvals, approval by Intra-Cellular Therapies’ stockholders, and other customary closing conditions for a transaction of this type. Following the completion of the transaction, Intra-Cellular Therapies’ common stock will no longer be listed for trading on the Nasdaq Global Select Market.
Citi is serving as financial advisor to Johnson & Johnson and Cravath, Swaine & Moore is serving as legal advisor. And Centerview Partners and Jefferies are serving as financial advisors to Intra-Cellular Therapies, and Davis Polk & Wardwell is serving as legal advisor.
KEY QUOTES:
“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. 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.”
– Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson
“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to 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.”
– Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson
“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. Johnson & Johnson has a longstanding commitment to neuroscience, and we believe together, we can reach even more patients around the world.”
– Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies
“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. 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.”
– John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson
