Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. announced that it has completed the acquisition of assets from BioXcel Therapeutics, Inc., including worldwide rights to BXCL501. BXCL501 is an investigational dexmedetomidine sublingual film under FDA review for at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, BXCL501 would be the first FDA-approved treatment patients could use at home for this condition. The acquisition expands Teva’s innovative neuroscience pipeline with a late-stage asset with the potential to address a significant unmet patient need.
“Business development plays an important role in accelerating our Pivot to Growth strategy by bringing targeted external innovation into Teva,” said Evan Lippman, Executive Vice President, Business Development at Teva. “BXCL501 is a strong strategic fit with our neuroscience portfolio and reflects our disciplined focus on differentiated, late-stage opportunities that address unmet patient needs and create long-term value for Teva’s shareholders.”
Acute agitation associated with schizophrenia or bipolar I or II disorder affects between 25% and 40%1 of patients across these conditions. Acute agitation can escalate quickly, creating significant challenges for patients, families and caregivers and, in some cases, resulting in an emergency department visit or hospitalization. Acute treatment options remain limited, particularly outside healthcare settings.
“Agitation can escalate quickly, which is why the ability to intervene early matters,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. “If approved, BXCL501 could give adults living with schizophrenia or bipolar I or II disorder the ability to treat agitation at home, closer to the moment symptoms emerge and before they could become more difficult to manage.”