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

BXCL501 是一种右美托咪定舌下膜剂，正接受美国食品药品监督管理局（FDA）的审评，拟首次获批用于成人急性治疗与精神分裂症或双相 I 型或 II 型障碍相关的激越症状，并允许在家庭环境中使用。

Acquisition adds differentiated late-stage investigational asset with potential to address a significant unmet need for patients

此次收购增加了一种差异化的后期研究资产，有望满足患者尚未被满足的重大需求。

Transaction supports Teva’s Pivot to Growth strategy and the company’s disciplined approach to business development

该交易支持梯瓦制药的“转向增长”战略及其在业务拓展方面的审慎策略

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.

以色列特拉维夫，2026年10月27日（环球电讯社）——梯瓦制药工业有限公司（纽约证券交易所和特拉维夫证券交易所代码：TEVA）的子公司梯瓦制药国际有限公司今日宣布，已完成对BioXcel Therapeutics, Inc.资产的收购，其中包括BXCL501的全球权利。

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.

BXCL501 是一种正在接受美国食品药品监督管理局（FDA）审评的右美托咪定舌下膜剂，用于成人急性治疗与精神分裂症或双相 I 型或 II 型障碍相关的激越症状，供居家使用。若获批准，BXCL501 将成为首款经 FDA 批准、患者可在家中用于治疗该病症的药物。

The acquisition expands Teva’s innovative neuroscience pipeline with a late-stage asset with the potential to address a significant unmet patient need..

此次收购为梯瓦的创新神经科学产品管线增添了一款后期资产，该资产有望满足重大的未竟患者需求。

“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.”.

“业务发展通过引入有针对性的外部创新，对加速我们向增长转型的战略发挥着重要作用。”梯瓦制药业务开发执行副总裁埃文·利普曼表示，“BXCL501与我们的神经科学产品组合具有高度的战略契合性，体现了我们 disciplined 地专注于差异化、后期阶段的机会，以满足尚未被满足的患者需求，并为梯瓦股东创造长期价值。”

Acute agitation associated with schizophrenia or bipolar I or II disorder affects between 25% and 40%

与精神分裂症或双相 I 型或 II 型障碍相关的急性激越发生率介于 25% 至 40% 之间

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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..

涉及这些状况的患者。急性激越可能迅速升级，给患者、家属和照护者带来重大挑战，在某些情况下甚至导致急诊就诊或住院。急性治疗选择仍然有限，尤其在医疗保健机构之外。

“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.”.

“激越症状可能迅速升级，因此早期干预的能力至关重要。”梯瓦（Teva）全球研发执行副总裁兼首席医疗官Eric Hughes医学博士、哲学博士表示。“如果获得批准，BXCL501将使患有精神分裂症或双相情感障碍I型或II型的成年患者能够在家中治疗激越症状，从而在症状出现时更早地进行干预，并在症状变得难以控制之前加以管理。”

About the Transaction

关于交易

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.

梯瓦制药通过美国《破产法》第363条规定的法院监督出售程序，收购了BioXcel Therapeutics, Inc.及其关联公司的神经科学资产。这些资产包括BXCL501和IGALMI®（右美托咪定）的全球权利，其中IGALMI®是一种经美国食品药品监督管理局（FDA）批准的右美托咪定舌下薄膜，用于在医院环境中治疗与精神分裂症或双相I型或II型障碍相关的激越症状。

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..

BXCL501的批准申请已作为对IGALMI®新药申请（NDA）的补充新药申请（sNDA）提交。该交易不涉及收购BioXcel Therapeutics公司。

The transaction closed following Teva’s selection as the successful bidder, approval by the U.S. Bankruptcy Court and satisfaction of other closing conditions.

在梯瓦被选为中标方、美国破产法院批准以及满足其他交割条件后，该交易完成交割。

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.

梯瓦以5750万美元的预付款及最高6750万美元的或有对价收购了相关资产。这些或有对价包括一系列与监管审批挂钩的基于时间的付款（涵盖审批可能延迟的情形），以及与实现特定销售里程碑挂钩的付款。

About dexmedetomidine sublingual film (BXCL501)

关于右美托咪定舌下膜（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..

右美托咪定是一种选择性α-2肾上腺素能受体激动剂。BXCL501是一种专有的、研究性的口腔溶解膜制剂，目前正接受美国食品药品监督管理局（FDA）的审评，旨在用于成人精神分裂症或双相I型或II型障碍相关激越症状的急性治疗，并可能用于居家场景。

About Teva

关于梯瓦

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.

梯瓦制药工业有限公司（纽约证券交易所和特拉维夫证券交易所代码：TEVA）正依托其世界一流的仿制药业务，转型为一家领先的创新型生物制药公司。120多年来，梯瓦致力于改善人类健康的承诺始终坚定不移。从在神经科学和免疫学领域的创新，到在全球提供复杂仿制药、生物类似药及药房品牌产品，梯瓦始终致力于满足患者当前及未来的需求。

At Teva, We Are .

在梯瓦，我们是。

All In For Better Health

全力投入，共创健康

. To learn more about how, visit www.tevapharm.com.

如需了解更多详情，请访问 www.tevapharm.com。

Teva Cautionary Note Regarding Forward-Looking Statements

梯瓦关于前瞻性陈述的警示说明

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.

本新闻稿包含经1995年《私人证券诉讼改革法案》界定的前瞻性陈述，这些陈述基于管理层当前的信念和预期，并受到已知和未知的重大风险和不确定性的影响，这些风险和不确定性可能导致梯瓦（Teva）未来的业绩、表现或成就与前述前瞻性陈述所明示或暗示的内容存在显著差异。

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.

除历史事实陈述外，所有陈述均属于或可能被视为前瞻性陈述。在某些情况下，您可以通过使用“应当”、“预期”、“预计”、“正在发展”、“目标”、“可能”、“扩张”、“打算”、“计划”、“相信”等词语，以及在与任何未来业绩讨论相关的其他具有类似含义和表达的词语和术语，来识别这些前瞻性陈述。

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 .

可能导致或促成此类差异的重要因素包括与以下方面相关的风险和不确定性：我们成功整合从 BioXcel Therapeutics, Inc. 收购的资产并实现其预期效益的能力；对批准该交易的破产出售命令所提出的任何适用上诉的解决情况；我们获得新型右美托咪定舌下薄膜监管批准并成功将其商业化的能力；我们在市场中成功竞争的能力，包括我们开发和商业化 ecopipam 及其他医药产品的能力；我们成功执行“转向增长”（Pivot to Growth）战略的能力，包括扩展我们的创新药和生物类似药管线，并盈利地商业化创新药物。

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..

前瞻性陈述仅反映其作出之日的情况，我们不承担因新信息、未来事件或其他原因而更新或修订本文所载任何前瞻性陈述或其他信息的义务。谨提醒您勿过度依赖这些前瞻性陈述。

Teva Media Inquiries:

梯瓦媒体问询：

TevaCommunicationsNorthAmerica@tevapharm.com

TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:

梯瓦投资者关系咨询：

TevaIR@Tevapharm.com

TevaIR@Tevapharm.com

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Teva Market Research via Trinity Partners, March 2026.

Teva 市场研究（由 Trinity Partners 提供），2026年3月。