Teva Pharmaceuticals International, a subsidiary of Teva Pharmaceutical Industries, has launched a bid to acquire BioXcel Therapeutics’ neuroscience asset, including its experimental dexmedetomidine sublingual film, in a court-supervised bankruptcy sale.

 

The drug is under review by the U.S. Food and Drug Administration (FDA) for potential at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. If approved, it could become the first FDA-approved at-home treatment specifically for this condition.

 

The proposed deal would give Teva worldwide rights to the asset and strengthen its psychiatry portfolio as the company seeks to expand its neuroscience business and target areas of significant unmet need.

 

“Business development plays a critical role in accelerating our Pivot to Growth strategy,” said Evan Lippman, Executive Vice President, Business Development at Teva. 

 

“This opportunity strengthens our neuroscience portfolio and reflects our disciplined approach to pursuing innovative assets with a clear strategic fit, the potential to make a meaningful difference for patients and attractive long-term growth potential, while balancing risk and value creation."

 

Under the agreement, Teva would pay $57.5 million upfront, with the potential for another $67.5 million in contingent payments. The additional payments include time-based payments linked to the timing of FDA approval—including potential delays—as well as payments tied to specified sales milestones.

 

Teva has agreed to act as the “stalking horse bidder” in a court-supervised auction under Section 363 of Chapter 11 of the U.S. Bankruptcy Code.

 

The initial bid covers certain assets of BioXcel Therapeutics and its affiliates, including IGALMI, the company’s dexmedetomidine sublingual film. The transaction does not involve the acquisition of BioXcel Therapeutics as a whole.

 

As the stalking horse bidder, Teva’s proposal establishes the opening bid for the assets. However, the deal is not guaranteed: Teva must emerge as the successful bidder in the auction, satisfy the required conditions and receive approval from the Bankruptcy Court.

 

If another bidder wins the auction, Teva would be entitled to a break-up fee and reimbursement of expenses, subject to the terms of its agreement with BioXcel.

 

Agitation can be unpredictable and distressing for people living with schizophrenia or bipolar I or II disorder, as well as their families and caregivers. Severe episodes can escalate to emergency department visits or hospitalization.

 

Treatment options designed specifically for acute agitation remain limited, particularly treatments that could potentially be administered outside hospitals and other healthcare settings.

 

If the FDA clears dexmedetomidine sublingual film for at-home use, the product could offer a new option for managing acute agitation without requiring immediate treatment in a healthcare facility.

 

The proposed acquisition would give Teva control of the asset’s worldwide rights, subject to the outcome of the bankruptcy auction and regulatory approval.