Statement issued by the company (Announcement)<\/p>\n
Teva Pharmaceutical Industries Ltd.<\/strong> (NYSE and TASE: TEVA), today announced the closing of Teva\u2019s acquisition of Emalex Biosciences<\/strong>, strengthening its late-stage pipeline with ecopipam and further advancing its Pivot to Growth strategy<\/strong>. Phase 3 data for ecopipam were\u00a0recently published in\u00a0<\/strong>JAMA Neurology<\/strong><\/em><\/a>, and\u00a0a\u00a0U.S. NDA submission\u00a0is\u00a0anticipated\u00a0in\u00a0the second half of\u00a02026.<\/p>\n \u201cThis acquisition reflects our Pivot to Growth strategy in action,\u00a0advancing our\u00a0innovative pipeline through focused, capital-efficient business development,\u201d said Richard Francis, President and Chief Executive Officer of Teva. \u201cIt adds a late-stage opportunity\u00a0with potential\u00a0to address a\u00a0significant\u00a0unmet need\u00a0in Tourette syndrome, and with our deep neuroscience expertise, we are well-positioned to advance\u00a0this program.\u201d<\/p>\n Emalex Biosciences was created by Paragon Biosciences<\/a> to develop new treatments for central nervous system disorders. Emalex, supported by Paragon,\u00a0advanced the asset through clinical development and compiled the NDA submission for pediatric Tourette syndrome.<\/p>\n Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics\u00a0beginning\u00a0in childhood, often between 5 and 10 years\u00a0of age. For people living with Tourette syndrome, symptoms can be frequent, visible, and disruptive, affecting everyday life. Current treatment approaches can help, but many patients still do not get the level of control they need, or are limited by side effects, underscoring the need for\u00a0additional\u00a0options.<\/p>\n Ecopipam is a first-in-class investigational compound designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.<\/p>\n Ecopipam has received Orphan Drug and Fast Track designations from the FDA for the treatment of pediatric\u00a0patients with\u00a0Tourette syndrome.\u00a0Orphan Drug designation is reserved for patient populations of 200,000 or fewer.<\/p>\n The Phase 3 Tourette syndrome study results were recently published in JAMA Neurology. The primary efficacy endpoint in the study was time to relapse for pediatric patients\u00a0stable and responding to ecopipam\u00a0then randomized\u00a0to ecopipam or placebo. The study showed statistical significance between ecopipam and placebo for the primary efficacy endpoint in pediatric patients (p = 0.0084). Ecopipam was\u00a0generally well-tolerated in the\u00a0study\u00a0and the most common adverse events related to ecopipam therapy were somnolence (10.2%), insomnia (7.4%), anxiety (6.0%), fatigue (5.6%), and headache (5.1%).<\/p>\n Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class\u00a0generics\u00a0business. For over 120 years, Teva\u2019s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines,\u00a0biosimilars\u00a0and pharmacy brands worldwide, Teva is dedicated to addressing patients\u2019 needs, now and in the future. At Teva, We Are All\u00a0In\u00a0For\u00a0Better Health. To learn more about how, visit\u00a0www.tevapharm.com<\/u><\/a>.<\/p>\n This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management\u2019s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva\u2019s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements.About Tourette Syndrome <\/strong><\/h2>\n
About ecopipam<\/h2>\n
About Teva<\/h2>\n
Cautionary Note Regarding Forward-Looking Statements<\/h2>\n
\nAll statements other than statements of historical fact are, or may be\u00a0deemed\u00a0to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as \u201cshould,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cdeveloping,\u201d \u201ctarget,\u201d \u201cmay,\u201d \u201cexpand,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cbelieve\u201d 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 meet the payment obligations under the\u00a0acquisition\u00a0agreement\u00a0of\u00a0Emalex; our ability to successfully develop, obtain regulatory approval for and commercialize ecopipam; 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\u00a0Quarterly Report on Form 10-Q for the first quarter of 2026 and in our\u00a0Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned \u201cRisk Factors\u201d and\u00a0\u201cCautionary Note Regarding Forward Looking Statements.\u201d
\nForward-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\u00a0contained\u00a0herein, whether\u00a0as a result of\u00a0new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.<\/p>\n