Dexmedetomidine Hydrochloride

Teva Pharmaceuticals said Tuesday it has successfully acquired BioXcel's neuroscience portfolio as part of the latter's Chapter 11 bankruptcy sale, after bidding up to $125 million on the assets. The drugmaker splashed $57.5 million upfront to buy Igalmi (dexmedetomidine), a sublingual film approved by the FDA in 2022 as an in-hospital treatment for agitation associated with schizophrenia or bipolar disorder in adults. Teva is also walking away with worldwide rights to BXCL501. Like Igalmi, it's a dexmedetomidine sublingual film, but instead of needing healthcare provider supervision during administration, it's designed to be taken at home. A supplemental NDA for BXCL501 as an acute agitation treatment is under review with the FDA. "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," said Evan Lippman, Teva's EVP of business development, in a company release. Teva is on the hook for up to $67.5 million in contingent payments related to BioXcel's assets, including a time-based payout for regulatory approval and specified sales milestones.Neuro pipeline buildout continues Igalmi and BXCL501 add to Teva's growing, neuro-focused innovative medicines portfolio, which helped stabilise the company's second-quarter revenues in the face of slowing generic sales. Its marketed products include Austedo (deutetrabenazine), cleared to treat tardive dyskinesia and chorea related to Huntington's disease; migraine medicine Ajovy (fremanezumab); Uzedy (risperidone), a treatment for schizophrenia and bipolar disorder; and Weltruza, a once-monthly injectable formulation of olanzapine approved for schizophrenia earlier this month (see – Physician Views Results: Weltruza well-positioned to win oral olanzapine switches, but weight gain woes pose threat)The drugmaker is leaning on dealmaking to bring external products into its innovative pipeline, which Teva is using to fuel its "Pivot to Growth" strategy. Tuesday's acquisition builds on the company's April purchase of Emalex Biosciences and its late-stage Tourette syndrome candidate ecopipam for $700 million upfront, which at the time represented Teva's first major M&A move in about a decade.

BXCL501, a dexmedetomidine sublingual film, is under FDA review for first-ever at-home use for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults Acquisition adds differentiated late-stage investigational asset with potential to address a significant unmet need for patients Transaction supports Teva’s Pivot to Growth strategy and the company’s disciplined approach to business development TEL AVIV, Israel, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today 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.” About the Transaction Teva acquired the neuroscience assets of BioXcel Therapeutics, Inc. and its affiliates through a court-supervised sale process under Section 363 of the U.S. Bankruptcy Code. The assets include worldwide rights to BXCL501 and IGALMI® (dexmedetomidine), an FDA-approved dexmedetomidine sublingual film for the treatment of agitation associated with schizophrenia or bipolar I or II disorder in a hospital setting. The application for the approval of BXCL501 has been submitted as a supplemental New Drug Application (NDA) to the IGALMI® NDA. The transaction does not involve the acquisition of BioXcel Therapeutics. The transaction closed following Teva’s selection as the successful bidder, approval by the U.S. Bankruptcy Court and satisfaction of other closing conditions. Teva acquired the assets for $57.5 million upfront and up to $67.5 million in contingent payments. These include a range of time-based payments linked to regulatory approval, including potential delays in approval, as well as payments tied to the achievement of specified sales milestones. About dexmedetomidine sublingual film (BXCL501) Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist. BXCL501 is a proprietary, investigational, orally dissolving film formulation currently under FDA review for potential at-home use in the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health . To learn more about how, visit Teva Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully integrate and realize the anticipated benefits of the acquired assets from BioXcel Therapeutics, Inc.; resolution of any applicable appeals to the bankruptcy sale order approving the transaction; ability to obtainability to obtain regulatory approval for and successfully commercialize the novel dexmedetomidine sublingual film; our ability to obtain regulatory approval for and successfully commercialize the novel dexmedetomidine sublingual film; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam and additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release and in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquiries: TevaIR@Tevapharm.com 1 Teva Market Research via Trinity Partners, March 2026.