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Medincell Proposes Board Appointments of Industry Veterans Dr. Sharon Mates and Dr. Charles Kunsch
Medincell Proposes Board Appointments of Industry Veterans Dr. Sharon Mates and Dr. Charles Kunsch

Business Wire

time29-07-2025

  • Business
  • Business Wire

Medincell Proposes Board Appointments of Industry Veterans Dr. Sharon Mates and Dr. Charles Kunsch

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL): Sharon Mates, PhD, is the co-founder and former Chair and CEO of Intra-Cellular Therapies, a CNS-focused biotech that developed the successful drug CAPLYTA ®, acquired by Johnson & Johnson for $14.6 billion in April 2025. Dr. Mates said: "Medincell is entering a new era and I'm excited to help shape its future. Its vision and achievements closely align with my passion for advancing medical innovation and delivering meaningful solutions for patients." Charles Kunsch, PhD, is a seasoned life sciences executive with over 30 years of experience, including as former Managing Director at AbbVie Ventures, where he led investments in pioneering biotech companies. Dr. Kunsch said: 'Throughout my career, I've seen how innovation and collaboration can transform bold ideas into meaningful impact. These values are deeply rooted at Medincell. They've already taken the company far and laid a strong foundation for a new phase of growth. I'm excited to contribute my experience to support the executive team and fellow board members in driving the company's continued success.' These nominations aim to further strengthen the expertise of Medincell's Board of Directors, which currently includes: Philippe Guy (Chairman) - Former Head of BCG's Global Health Care Practice and member of BCG's Worldwide Executive Committee Christophe Douat - CEO of Medincell Elisabeth Kogan - CEO of Clexio Bioscience, former SVP at Teva where she led global generic and specialty R&D Tone Kvåle - CFO of Herantis Pharma, with over 25 years of biotech finance leadership Virginie Lleu - Senior Partner at WittKieffer, with over 30 years of experience in executive search for the pharmaceutical industry Pascal Touchon - Former Global Head of Cell & Gene Therapy at Novartis Oncology, CEO then Chairman of Atara Biotherapeutics, Inc. Philippe Guy, Chairman of the Board of Medincell, said: 'The Board has made it a priority to strengthen its collective expertise in preparation for the future. The addition of Dr. Mates and Dr. Kunsch brings a wealth of experience in innovation, strategic vision, and influential networks. Their contributions will play a key role in reinforcing our leadership, expanding our impact, and creating lasting value.' Christophe Douat, CEO and Director of Medincell, said: 'The coming years will be the most transformative in Medincell's history. Sharon and Charles will bring invaluable experience and world-class expertise in science and innovation to our Board, as Medincell remains deeply committed to improving patients' lives.' The appointments of Dr. Mates and Dr. Kunsch, along with that of Pascal Touchon - who was previously appointed by Medincell's Board of Directors (see press release) - is subject to shareholder approval at the General Assembly to be held on September 11, 2025. About Dr. Mates Sharon Mates, Ph.D., co-founded Intra-Cellular Therapies in 2002 with Nobel Laureate Dr. Paul Greengard, building the company on his groundbreaking research into intracellular signaling to pioneer treatments for psychiatric and neurologic disorders. As Co-founder, Chairman and CEO, Dr. Mates led the development of CAPLYTA ® (lumateperone), a breakthrough therapy for schizophrenia and bipolar depression, with analysts projecting peak annual sales of up to $5 billion. Under her leadership, the company went public and grew to a market capitalization of over $10 billion before its acquisition by Johnson & Johnson for $14.6 billion in April 2025. Previously, for almost a decade, Dr. Mates served as President of North American Vaccine Inc., where she oversaw the development of pediatric vaccines. She holds a Ph.D. in anatomy and neuroscience and completed her postdoctoral training at Harvard Medical School and Massachusetts General Hospital. In addition to her scientific leadership as a research analyst and investment banker in the life sciences sector, she has co-founded several biotech companies and has sat on several non-profit boards. Dr. Mates was named to Forbes' '50 Over 50 – Innovation' list in recognition of her lasting impact on neuroscience and biotech innovation. About Dr. Kunsch Charles Kunsch, Ph.D., is a seasoned life sciences executive and investor with over 30 years of leadership in R&D, venture capital, and biotech innovation. He served as Managing Director at AbbVie Ventures, where he led investments in manyhigh-impact biotech companies including Prevail Therapeutics (acquired by Lilly) and Tidal Therapeutics (acquired by Sanofi) among others. Earlier in his career, he held senior scientific roles at AbbVie, AtheroGenics and Human Genome Sciences. Kunsch holds a Ph.D. in Immunology from Pennsylvania State University College of Medicine and completed postdoctoral training at the Roche Institute of Molecular Biology. He currently serves as a Venture Partner at Dreavent Capital, Vice Chair of the Board at Massachusetts Biomedical Initiatives, Board of Trustees of the Penn State Research Foundation, and is a board member at Captor Therapeutics, Antiverse and NextRNA. About Medincell Medincell is a clinical and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO ® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities. This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities. These statements may include, but are not limited to, any statements beginning with, followed by or including words or expressions such as "objective", "believe", "expect", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words or expressions of similar meaning or used in the negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control which may cause actual results, performance or achievements of the Company to differ materially from those anticipated or implied by such statements. A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in documents and reports to be published subsequently by the Company. Furthermore, these forward-looking statements only apply as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update these forward-looking statements, nor to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available. The Company's updating of one or more forward-looking statements does not imply that it will or will not update these or any other forward-looking statements. This press release is published for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for securities of the Company in any jurisdiction whatsoever, particularly in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not intended to address the investment objectives, financial situation or specific needs of any particular recipient. It should not be relied upon as a substitute for the exercise of your own judgement. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be restricted by law in certain jurisdictions. Persons into whose possession this press release comes are required to inform themselves about and to observe any such restrictions.

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Yahoo

time08-07-2025

  • Health
  • Yahoo

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia TITUSVILLE, N.J., July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of On average, an adult with schizophrenia experiences nine relapses in less than six "Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA® and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders." While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies, 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. 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® is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA® has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders. Editor's note: a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Schizophrenia Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.v,vi A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with About Study 304This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. About CAPLYTA® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA® is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA® is not FDA-approved for these disorders. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and 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 Warnings. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of CAPLYTA®. 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 of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes i Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. GlobeNewswire, 05 Nov. 2024, ii "Schizophrenia Fact Sheet." Treatment Advocacy Center, 10 Mar. 2025, iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 iv Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705 v Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand journal of psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 vi Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/ View original content to download multimedia: SOURCE Johnson & Johnson

Johnson & Johnson Announces Expected Closing Date for Intra-Cellular Acquisition
Johnson & Johnson Announces Expected Closing Date for Intra-Cellular Acquisition

Yahoo

time01-04-2025

  • Business
  • Yahoo

Johnson & Johnson Announces Expected Closing Date for Intra-Cellular Acquisition

NEW BRUNSWICK, N.J., April 01, 2025--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced that following the approval of its pending acquisition of Intra-Cellular Therapies, Inc. by Intra-Cellular Therapies' shareholders on March 27, 2025, Johnson & Johnson intends to complete its acquisition of Intra-Cellular Therapies on or around April 2, 2025. The transaction is expected to accelerate 2025 sales growth for Johnson & Johnson by approximately 0.8% with approximately $0.7 billion in incremental sales. Inclusive of the impact of financing costs, Johnson & Johnson expects the transaction to dilute adjusted earnings per share (EPS) by approximately $0.25 in 2025, an improvement from the $0.30 – $0.35 originally estimated on the Company's Q4 2024 earnings call. In 2026, Johnson & Johnson expects the earnings dilution to be reduced to approximately $0.21 per share as annualized financing costs are partially offset by operational accretion. Johnson & Johnson will include these estimates in its full-year 2025 financial outlook when it reports first quarter results on April 15, 2025. Following the completion of the transaction, Intra-Cellular Therapies' common stock will cease trading on the NASDAQ Global Select Market. This release corrects a prior statement that the closing had occurred. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS: This press release contains "forward-looking statements" regarding the acquisition of Intra-Cellular Therapies by Johnson & Johnson and 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 of Johnson & Johnson or Intra-Cellular Therapies. Risks and uncertainties include, but are not limited to: the completion of the acquisition in the expected timeframe; 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 of Intra-Cellular Therapies. A further list and description of these risks, uncertainties and other factors and the general risks associated with the respective businesses of Johnson & Johnson and Intra-Cellular Therapies can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2024, filed with the SEC on February 13, 2025, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent filings with the SEC and in Intra-Cellular Therapies' Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025, including in the sections captioned "Cautionary Statement Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Intra-Cellular Therapies' subsequent filings with the SEC. Copies of these filings, as well as subsequent filings, are available online at or on request from Johnson & Johnson or Intra-Cellular Therapies. Neither Johnson & Johnson nor Intra-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. View source version on Contacts Johnson & JohnsonMedia Contact: media-relations@ Investor Contact: investor-relations@ Sign in to access your portfolio

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