Johnson & Johnson has agreed to acquire Intra-Cellular Therapies for approximately $14.6 billion, the companies said today, in the largest biopharma merger-and-acquisition (M&A) deal announced in two years—and one that reflects the continuing comeback of interest by pharma giants in neurological drug development during this decade.
“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.”
The deal comes a year after Intra-Cellular appeared on GEN’s A-List of “Top 10 Biopharma Takeover Targets of 2024,” and one month after Intra-Cellular submitted a supplemental new drug application (sNDA) to the FDA for CAPLYTA® (lumateperone) as an adjunctive treatment for adults with major depressive disorder (MDD).
The sNDA is supported by data from two global, double-blind, placebo-controlled Phase III studies showing CAPLYTA, achieved statistically significant and clinically meaningful improvement in depressive symptoms when used as an adjunctive treatment to antidepressants, as measured by both clinician-rated and patient-reported outcomes.
If the sNDA is approved, CAPLYTA could be the first treatment approved for MDD and depressive symptoms associated with bipolar I and II in more than 15 years.
CAPLYTA is already approved and marketed for se in adults to treat schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
J&J and Intra-Cellular said additional Phase III trials are underway with CAPLYTA in bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania). In November, Intra-Cellular announced positive topline results on the efficacy and safety of CAPLYTA in preventing relapse in adults with schizophrenia.
According to Intra-Cellular, CAPLYTA is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses, the companies said, though the drug’s exact mechanism of action is unknown.
Based in Bedminster, NJ, Intra-Cellular specializes in developing therapies for Central Nervous System disorders.
J&J agreed to acquire all outstanding shares of Intra-Cellular for $132 a share. J&J said is expected to fund acquisition deal through a combination of cash on hand and debt. The transaction is expected to close later this year subject to applicable regulatory approvals, approval by Intra-Cellular Therapies’ stockholders and other customary closing conditions.
