On 13 January 2024, Johnson & Johnson (J&J) announced the acquisition of Intra-Cellular Therapies, a biopharmaceutical company specialising in developing treatments targeting complex psychiatric and neurological disorders. The deal is valued at $14.6 billion and is the biggest biotech mergers and acquisitions transaction since 2023. J&J will obtain Intra-Cellular’s extensive neurology portfolio as part of the acquisition. This includes Intra-Cellular’s Caplyta, approved for bipolar I and II disorders and schizophrenia, which is also under current US Food and Drugs Administration (FDA) review for major depressive disorder. Intra-Cellular’s clinical-stage pipeline is also promising, with pipeline agents under development for a wide range of neurological indications, including generalised anxiety disorder, agitation and psychosis in Alzheimer’s disease, Parkinson’s disease, and opioid use disorder.
Adding Caplyta to J&J’s lineup of psychiatric therapies may present a very shrewd acquisition. GlobalData forecasts that, as a therapy for schizophrenia, Caplyta could drive sales of $229 million by 2033 in the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US). Key opinion leaders (KOLs) previously interviewed by GlobalData have noted that Caplyta is more tolerable than other antipsychotics as it causes less weight gain. Another advantage that Caplyta holds over other antipsychotics is its versatility, as it is being investigated in psychiatric indications other than schizophrenia and bipolar disorder, in which it originally received approval.
Caplyta is currently under FDA review for major depressive disorder (MDD), with a decision anticipated in the first half of 2025. GlobalData forecasts that Caplyta could generate sales of $640 million in MDD by 2029 in the 7MM. KOLs have stated that the antidepressant effects of atypical antipsychotics are typically mediated via 5-HT2A receptor blockade and that the main advantage is that 5-HT2A antagonists such as Caplyta are presumed to be free of metabolic and movement side effects.
As part of the acquisition, J&J would add several agents to its neurology pipeline, including the Phase II asset ITI-1284, for generalised anxiety disorder and Alzheimer’s disease-related psychosis and agitation. Anti-agitation and anti-psychosis drugs present a major part of the Alzheimer’s disease treatment landscape and GlobalData forecasts that anti-agitation and anti-psychosis drugs could produce sales of $1.4 billion by 2033 in eight major pharmaceutical markets (China, France, Germany, Japan, Italy, Spain, the UK and the US). J&J is already a prominent force in Alzheimer’s, with Reminyl, Haldol and Risperdal in its portfolio of products targeting it along with Alzheimer’s-related psychosis and agitation. The addition of ITI-1284 bolsters J&J’s Alzheimer’s pipeline and could allow the company to further cement its position as a major player in the Alzheimer’s-related psychosis and agitation segment of the market — that is, should ITI-1284 benefit from J&J’s extensive capital and research and development capabilities and gain approval.
J&J’s acquisition of Intra-Cellular Therapies presents a significant synergy of expertise in neuropsychiatric conditions and signals J&J’s intent to diversify its portfolio of products within the central nervous system diseases market. The addition of Caplyta could be particularly significant given its versatility as a proven treatment for schizophrenia and bipolar disorder, as well as a potential label expansion into MDD. Pipeline agents included in the deal, such as ITI-1284, may allow J&J to achieve greater market share in Alzheimer’s. Other pipeline agents in the deal include those being developed as new therapeutic indications for J&J, such as Parkinson’s disease and opioid use disorder, allowing J&J to gain a foothold in these indications.
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By GlobalData