Teva Pharmaceuticals has agreed to serve as the stalking-horse bidder for certain BioXcel Therapeutics assets, including a dexmedetomidine sublingual film under FDA review for at-home treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
The proposed transaction is being conducted through a court-supervised sale under Section 363 of Chapter 11 of the U.S. Bankruptcy Code. It remains subject to bankruptcy-court approval, potential higher bids at auction and customary closing conditions.
Teva would acquire worldwide rights to the agreed-upon assets for $57.5 million upfront and up to an additional $67.5 million in contingent payments. The potential payments include time-based amounts associated with timing of a pending FDA decision, including potential approval delays, and payments tied to specified sales milestones.
If Teva is not selected as the winning bidder, it would be entitled to a break-up fee and reimbursement of expenses, subject to the terms of the agreement. The transaction does not involve acquisition of BioXcel Therapeutics as a whole.
The principal asset, dexmedetomidine sublingual film, is also known as BXCL501. It is a proprietary orally dissolving formulation of a selective alpha-2 adrenergic receptor agonist. The drug is under FDA review for potential at-home use in acute agitation associated with schizophrenia or bipolar I or II disorder in adults. The FDA has set a Nov. 14, 2026, target action date.
If approved, Teva said the therapy could become the first FDA-approved treatment for use at home for acute agitation in these conditions. Current treatment options designed for use outside healthcare facilities and hospital settings are limited, according to the company.
BioXcel’s currently approved IGALMI, also dexmedetomidine sublingual film, is administered under healthcare-provider supervision for acute agitation in adults with schizophrenia or bipolar I or II disorder. The drug’s use has not been studied beyond 24 hours after the first dose.
IGALMI carries warnings for low blood pressure, decreased blood pressure upon standing, slow heart rate, QT interval prolongation, drowsiness and potential withdrawal reactions, tolerance and reduced response with use beyond 24 hours. Common side effects include drowsiness, oral numbness or tingling, dizziness, dry mouth and low blood pressure.
Evan Lippman, Teva’s executive vice president of business development, said the proposed asset purchase supports the company’s Pivot to Growth strategy and would expand its neuroscience portfolio if completed.
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