© 2025 Intra-Cellular Therapies Inc. All rights reserved.
Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.
Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.
January 13, 2025 at 6:30 AM EST
Acquisition includes CAPLYTA® (lumateperone), the first and only
sNDA submitted to
CAPLYTA® adds to Johnson & Johnson’s robust lineup of therapies with
Promising clinical-stage pipeline with best-in-disease potential in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation
“Building on our nearly 70-year legacy in neuroscience, this unique opportunity to add
With this agreement,
“We are excited to welcome Intra-Cellular Therapies’ talented people and world-class expertise to Johnson & Johnson,” said
“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.
In
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,
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
- 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
- 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
- An estimated 21 million adults live with MDD, one of the most common psychiatric disorders and a leading cause of disability;vii
- About 6.8 million adults live with GAD, a mental and behavioral disorder that causes excessive and uncontrollable worry and fear;v and,
- 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,
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.
Advisors
Citi is serving as financial advisor to
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:
- 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.
- 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:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- 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. - 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.
- 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.
- 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.
- 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. - 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®.
- Seizures. CAPLYTA® should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA® affects them.
- 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. - 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.
About
At
About
ADDITIONAL INFORMATION AND WHERE TO FIND IT
This press release may be deemed to be solicitation material in respect of the proposed acquisition of
PARTICIPANTS IN THE SOLICITATION
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS:
- This press release contains “forward-looking statements” regarding the acquisition of
Intra-Cellular Therapies byJohnson & Johnson and Intra-Cellular Therapies’ product CAPLYTA® and development programs. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections ofJohnson & Johnson orIntra-Cellular Therapies . - Risks and uncertainties include, but are not limited to: the risk that the closing conditions for the acquisition will not be satisfied, including the risk that clearance under the Hart-Scott-Rodino Antitrust Improvements Act will not be obtained; uncertainty as to the percentage of
Intra-Cellular Therapies stockholders that will vote to approve the proposed transaction at theIntra-Cellular Therapies stockholder meeting; the possibility that the transaction will not be completed in the expected timeframe or at all; potential adverse effects to the businesses ofJohnson & Johnson orIntra-Cellular Therapies during the pendency of the transaction, such as employee departures or distraction of management from business operations; the risk of stockholder litigation relating to the transaction, including resulting expense or delay; the potential that the expected benefits and opportunities of the acquisition, if completed, may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment. - In addition, there will be risks and uncertainties related to the ability of the
Johnson & Johnson family of companies to successfully integrate the programs, products, technologies and employees/operations and clinical work ofIntra-Cellular Therapies . A further list and description of these risks, uncertainties and other factors and the general risks associated with the respective businesses ofJohnson & Johnson andIntra-Cellular Therapies can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year endedDecember 31, 2023 , filed with theSEC onFebruary 16, 2024 , including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s most recently filed Quarterly Report on Form 10-Q and Johnson & Johnson’s subsequent filings with theSEC and in Intra-Cellular Therapies’ Annual Report on Form 10-K for the fiscal year endedDecember 31, 2023 , filed with theSEC onFebruary 22, 2024 , including in the sections captioned “Cautionary Statement Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Intra-Cellular Therapies’ most recently filed Quarterly Report on Form 10-Q and Intra-Cellular Therapies’ subsequent filings with theSEC . Copies of these filings, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com, www.intracellulartherapies.com, or on request fromJohnson & Johnson orIntra-Cellular Therapies . - Neither
Johnson & Johnson norIntra-Cellular Therapies undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law.
________________
Footnotes
iNon risk adjusted peak year sales including partner sales
ii
iii Regier DA, Farmer ME, Rae DS, et al. One–month prevalence of mental disorders in
iv
v
vi
vii
viii 2024 Alzheimer's disease facts and figures. Alzheimer’s Dement. 2024;20(5):3708-3821. doi:10.1002/alz.13809.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250113969534/en/
Media Contact:
media-relations@its.jnj.com
Investor Contact:
investor-relations@its.jnj.com
Media Contact:
eweinstein@skdknick.com
Investor Contact:
jsanchez@itci-inc.com
Source: