On January 13, 2025 Johnson & Johnson (NYSE: JNJ) and Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) reported 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 $132.00 per share in cash for a total equity value of approximately $14.6 billion (Press release, Intra-Cellular Therapies, JAN 13, 2025, View Source [SID1234649662]).
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"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, 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), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. The 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.
"We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, 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."
"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 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."
In December 2024, Intra-Cellular Therapies announced the submission of 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). In two global, double-blind, placebo-controlled Phase 3 studies, CAPLYTA, as an adjunctive treatment to antidepressants, demonstrated 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, 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. Additional 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.
While 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. 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 common reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. 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.
"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," said John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, 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."
As the mental health crisis surges and the global population ages, more than one billion people worldwide – or 1 in every 8 people – are living with a neuropsychiatric or neurodegenerative disorder. In the United States:
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About 2.4 million adults live with schizophrenia, a serious, chronic mental illness that causes distortions in thinking, perceptions, emotions, and behavior;ii,iii,iv
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Approximately 6.1 million adults 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;v,vi
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An estimated 21 million adults live with MDD, one of the most common psychiatric disorders and a leading cause of disability;vii
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About 6.8 million adults live with GAD, a mental and behavioral disorder that causes excessive and uncontrollable worry and fear;v and,
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Approximately 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 significantly interfere with daily life.viii
Transaction Details and Path to Completion
Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies for a payment of $132.00 per share in cash. Johnson & Johnson expects to fund the transaction through a combination of cash on hand and debt. Johnson & Johnson expects to maintain a strong balance sheet and to continue to support its stated capital allocation priorities of R&D investment, competitive dividends, value-creating acquisitions, and strategic share repurchases.
The closing of the transaction is expected to occur 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 completion of the transaction, Intra-Cellular Therapies’ common stock will no longer be listed for trading on the Nasdaq Global Select Market.
Johnson & Johnson will provide commentary on any potential impact to Adjusted Earnings Per Share (EPS) from the transaction when it provides its initial full year 2025 guidance during the fourth quarter earnings call on Wednesday, January 22, 2025.
Advisors
Citi is serving as financial advisor to Johnson & Johnson, and Cravath, Swaine & Moore is serving as legal advisor.
Centerview Partners LLC and Jefferies are serving as financial advisors to Intra-Cellular Therapies, and Davis Polk & Wardwell LLP is serving as legal advisor.
Indication
CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Important Safety Information
Boxed Warnings:
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Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
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Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
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Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
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Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
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Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
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Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
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Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
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Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy, or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
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Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
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Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
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Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
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Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
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Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.
CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.
Please click here to see full Prescribing Information including Boxed Warning.