Dexmedetomidine Hydrochloride

Teva has agreed to bid up to $125 million for BioXcel Therapeutics' neuroscience assets, including marketed agitation treatment Igalmi (dexmedetomidine), as the struggling biotech enters Chapter 11 bankruptcy. Teva will serve as the stalking-horse bidder in a court-supervised auction for substantially all of BioXcel's assets. Under the agreement, Teva would pay $57.5 million upfront for worldwide rights to the assets, with up to another $67.5 million in contingent payments. The latter includes payments linked to the timing of potential FDA approval for outpatient use of Igalmi, as well as specified sales milestones. The transaction remains subject to bankruptcy court approval. Igalmi was cleared by the FDA in 2022 as an acute treatment for agitation associated with schizophrenia or bipolar disorder in adults. The sublingual film is administered under the supervision of a healthcare provider. Strained finances However, BioXcel said in May it was exploring strategic ⁠options to "advance the commercial and development plans for Igalmi," including a sale, merger or licensing agreement of its assets, among other options. BioXcel listed debts of approximately $104.5 million and assets of $28.8 million in its Chapter 11 petition filed this week with the US Bankruptcy ⁠Court for the District of Delaware. Igalmi's first-quarter revenues reached only $206,000 and the company posted a net loss of $12.7 million, with $17.2 million in cash, cash equivalents and restricted cash as of the end of March. Teva's proposed acquisition also covers BioXcel's pending application seeking approval for potential at-home use of the drug in the same disease areas; a decision is expected by Nov. 16. If US regulators give the all-clear, it could become the first FDA-approved at-home treatment specifically for acute agitation associated with schizophrenia or bipolar disorder. "This opportunity strengthens our neuroscience portfolio and reflects our disciplined approach to pursuing innovative assets with a clear strategic fit…while balancing risk and value creation," said Evan Lippman, EVP of business development at Teva, in a company release. Meanwhile, BioXcel said it has secured a debtor-in-possession financing commitment of $19 million from existing secured lenders to fund operations during the proceedings, while indicating that Igalmi remains commercially available. The content above comes from the network. if any infringement, please contact us to modify.

BXCL501 is under US FDA review for possible at-home treatment of acute agitation in adults with schizophrenia. Credit: Tapati Rinchumrus/Shutterstock.com. Teva Pharmaceuticals International has made a bid to acquire a range of neuroscience assets from BioXcel Therapeutics for a total deal value of $125m. The agreement arises as part of BioXcel Therapeutics’ voluntary Chapter 11 proceedings in the US Bankruptcy Court for the District of Delaware, initiating a court-supervised sale of the company’s main assets. The proposed transaction would see Teva obtain worldwide rights to Igalmi (dexmedetomidine) sublingual film, a prescription medicine, and the investigational BXCL501. BXCL501 is currently being reviewed by the US Food and Drug Administration (FDA) for potential at-home use in treating acute agitation linked to schizophrenia or bipolar I or II disorder in adults. Teva has been designated as the “stalking horse bidder”, setting the initial offer for the assets in the Section 363 auction process under the US Bankruptcy Code. Should Teva not prevail as the successful bidder, the company would receive a break-up fee and reimbursement of certain expenses, as outlined in the agreement. The upfront consideration for the assets totals $57.5m, with up to a further $67.5m in contingent payments linked to FDA approval timing and specified sales milestones. Teva business development executive vice-president Evan Lippman said: “Business development plays a critical role in accelerating our Pivot to Growth strategy. 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.” Igalmi remains available commercially during this process. BioXcel Therapeutics is seeking to facilitate the sale of substantially all its assets through the auction process, aiming to maximise stakeholder value. The company has also secured $19m in debtor-in-possession financing from existing lenders to maintain operations and support the court process. BioXcel Therapeutics intends to continue supporting patients, prescribers, and commercial partners during the proceedings.