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Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Acquisition includes CAPLYTA (lumateperone), the first and only U.S. FDA-approved treatment f

Key Takeaway: Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Acquisition includes CAPLYTA (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved

Full Press Release Details

Johnson & Johnson Strengthens
Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.
Acquisition includes
CAPLYTA (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also
approved for the treatment of schizophrenia in adults
sNDA submitted to U.S. FDA for
CAPLYTA as adjunctive treatment for major depressive disorder; if approved, CAPLYTA has potential to become a standard of care for
most common depressive disorders
CAPLYTA adds to Johnson & Johnson s
robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade
Promising clinical-stage pipeline with best-in-disease potential in
generalized anxiety disorder and Alzheimer s disease-related psychosis and agitation
New Brunswick, N.J. and Bedminster, N.J.,
January 13, 2025 Johnson & Johnson (NYSE: JNJ) and Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced today 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.
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.
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
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
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:
Transaction Details and Path to Completion
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
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.
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
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
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:
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 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 www.jnj.com/.
Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies is a biopharmaceutical company founded
on Nobel Prize-winning research that allows us to understand how therapies affect the inner workings of cells in the body. The company leverages this intracellular approach to develop innovative
treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
release may be deemed to be solicitation material in respect of the proposed acquisition of Intra-Cellular Therapies by Johnson & Johnson. In connection with the proposed transaction, Intra-Cellular Therapies intends to file relevant
materials with the U.S. Securities and Exchange Commission ( SEC ), including Intra-Cellular Therapies proxy statement in preliminary and definitive form. INVESTORS AND STOCKHOLDERS OF INTRA-CELLULAR THERAPIES ARE URGED TO READ ALL
RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING INTRA-CELLULAR THERAPIES PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED
TRANSACTION. Investors and stockholders of Intra-Cellular Therapies are or will be able to obtain these materials (when they are available) free of charge at the SEC s website at www.sec.gov, or free of charge from Intra-Cellular
Therapies website at www.intracellulartherapies.com.
PARTICIPANTS IN THE SOLICITATION
Johnson & Johnson and Intra-Cellular Therapies and certain of their respective directors and executive officers, under SEC rules, may be deemed to be
participants in the solicitation of proxies from stockholders of Intra-Cellular Therapies in connection with the proposed transaction. Information about Johnson & Johnson s directors and executive officers is available in
Johnson & Johnson s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 16, 2024, and Johnson & Johnson s definitive
proxy statement for its 2024 annual meeting of stockholders, which was filed with the SEC on March 13, 2024. Information about Intra-Cellular Therapies directors and executive officers is available in Intra-Cellular Therapies Annual
Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on February 22, 2024, and Intra-Cellular Therapies definitive proxy statement for its 2024 annual meeting
of stockholders, which was filed with the SEC on April 29, 2024. To the extent holdings of Johnson & Johnson s or Intra-Cellular Therapies securities by their respective directors or executive officers have changed since the
amounts set forth in such 2024 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, including the Form 3 filed by
Sanjeev Narula on August
14, 2024 and the Form 4s filed by: Sharon Mates on August
30, 2024 and December
6, 2024; Joel S. Marcus on June
25, 2024; Rory B. Riggs on June
15, 2024 and January
3, 2025; Eduardo Rene Salas on June
25, 2024; Robert L. Van Nostrand on June
Last updated: Jan 13, 2025