Teva Presents New Part 3 Efficacy, Security and Tolerability Information from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a As soon as-Month-to-month Subcutaneous Lengthy-Performing Injectable for Grownup Sufferers Identified with Schizophrenia

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• There have been no reported instances of PDSS.¹
• Remedy-emergent adversarial occasions that occurred extra typically in sufferers receiving TEV-‘749 versus placebo included weight enhance (35% [173/500] versus 8% [13/167]), injection web site induration (13% [64/500] versus 2% [4/167]), injection web site ache (10% [50/500] versus 4% [7/167]) and injection web site erythema (10% [48/500] versus 1% [1/167]).¹
• Critical adversarial occasions and discontinuations resulting from adversarial occasions had been reported in 1% (7/500) and three% (16/500) of sufferers handled with TEV-‘749, respectively, and in 2% (3/167) and three% (5/167) of sufferers handled with placebo, respectively.¹

Additionally offered at ECNP 2024, outcomes from the Part 1 examine of TEV-‘749 present comparable security and tolerability outcomes, together with no studies of PDSS occasions. Moreover, a offered pre-clinical examine means that the subcutaneous route of administration and formulation traits of TEV-‘749 seem to significantly scale back the hypothesized danger of PDSS incidence for sufferers receiving the remedy.

The long-term security of TEV-‘749 and incidence of PDSS are additionally being evaluated within the SOLARIS open-label examine (Interval 2), with security knowledge topline readout anticipated within the first half of 2025.

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TEV-‘749 makes use of SteadyTeq™, a copolymer expertise proprietary to Medincell that gives a managed regular launch of olanzapine.

TEV-‘749 is an investigational once-monthly subcutaneous LAI of the two^nd era antipsychotic olanzapine and isn’t authorised by any regulatory authority for any use, and its security and efficacy should not established.

About Subcutaneous OLAnzapine Prolonged-Launch Injection Research (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled examine to guage the efficacy, security and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a remedy in sufferers (ages 18-65 years) with schizophrenia. For interval one of many examine (first 8 weeks), 675 sufferers had been randomized to obtain a subcutaneous injection of once-monthly TEV-‘749 (low, medium or excessive dose) or placebo in a 1:1:1:1 ratio. For interval two, which can final for as much as 48 weeks, sufferers who accomplished interval one had been randomized and equally allotted to one of many three TEV-‘749 remedy teams. The top-of-treatment and follow-up visits will likely be at 4 and eight weeks after administration of the final remedy dose, respectively. The first goal of the Part 3 SOLARIS examine was to guage the efficacy of TEV-‘749 in grownup sufferers with schizophrenia. A key secondary goal was to additional consider the efficacy of TEV-‘749 primarily based on further parameters in grownup sufferers with schizophrenia. A secondary goal that’s nonetheless ongoing by way of interval two of the examine is to guage the security and tolerability of TEV-‘749 in grownup sufferers with schizophrenia.

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About Schizophrenia
Schizophrenia is a continual, progressive and severely debilitating psychological dysfunction that impacts how one thinks, feels and acts.¹ Sufferers expertise an array of signs, which can embrace delusions, hallucinations, disorganized speech or habits and impaired cognitive means.^1,2,3 Roughly 1% of the world’s inhabitants will develop schizophrenia of their lifetime, and three.5 million individuals within the U.S. are at the moment recognized with the situation.^2,3 Though schizophrenia can happen at any age, the typical age of onset tends to be within the late teenagers to the early 20s for males, and the late 20s to early 30s for girls.³ The long-term course of schizophrenia is marked by episodes of partial or full remission damaged by relapses that always happen within the context of psychiatric emergency and require hospitalization.³ Roughly 80% of sufferers expertise a number of relapses over the primary 5 years of remedy, and every relapse carries a organic danger of lack of operate, remedy refractoriness, and modifications in mind morphology.^4,5,6 Sufferers are sometimes unaware of their sickness and its penalties, contributing to remedy nonadherence, excessive discontinuation charges, and in the end, vital direct and oblique healthcare prices from subsequent relapses and hospitalizations.^1,2,3,4,5,6

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About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a worldwide pharmaceutical chief with a category-defying portfolio, harnessing our generics experience and stepping up innovation to proceed the momentum behind the invention, supply, and expanded growth of recent medication. For over 120 years, Teva’s dedication to bettering well being has by no means wavered. As we speak, the corporate’s world community of capabilities allows its 37,000 workers throughout 58 markets to push the boundaries of scientific innovation and ship high quality medicines to assist enhance well being outcomes of hundreds of thousands of sufferers every single day. To be taught extra about how Teva is all in for higher well being, go to www.tevapharm.com.

About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing firm growing long-acting injectable medication in lots of therapeutic areas. Our modern remedies intention to ensure compliance with medical prescriptions, to enhance the effectiveness and accessibility of medicines, and to cut back their environmental footprint. They mix energetic pharmaceutical elements with our proprietary BEPO^® expertise which controls the supply of a drug at a therapeutic stage for a number of days, weeks or months from the subcutaneous or native injection of a easy deposit of some millimeters, totally bioresorbable. The primary remedy primarily based on BEPO^® expertise, supposed for the remedy of schizophrenia, was authorised by the FDA in April 2023, and is now distributed in the US by Teva beneath the title UZEDY^® (BEPO^® expertise is licensed to Teva beneath the title SteadyTeq™). We collaborate with main pharmaceutical corporations and foundations to enhance world well being by way of new remedy choices. Based mostly in Montpellier, Medincell at the moment employs greater than 140 individuals representing greater than 25 completely different nationalities. www.medincell.com

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Word: TEV-‘749 is referenced as mdc-TJK in Medincell’s documentation and company web site.

Cautionary Word Relating to Ahead-Trying Statements
This press launch accommodates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995, that are primarily based on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each identified and unknown, that might trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. You’ll be able to establish these forward-looking statements by means of phrases akin to “ought to,” “anticipate,” “anticipate,” “estimate,” “goal,” “might,” “challenge,” “steerage,” “intend,” “plan,” “imagine” and different phrases and phrases of comparable that means and expression in reference to any dialogue of future working or monetary efficiency. Vital elements that might trigger or contribute to such variations embrace dangers regarding: our means to efficiently develop olanzapine LAI (TEV-‘749) for the remedy of adults with schizophrenia; our means to realize profitable outcomes from the Part 3 trial for olanzapine LAI (TEV-‘749), together with the efficacy and security parts; our means to efficiently compete within the market, together with our means to develop and commercialize further pharmaceutical merchandise; our means to efficiently execute our Pivot to Progress technique, together with to profitably commercialize the modern medicines and biosimilar portfolio, whether or not organically or by way of enterprise growth; the effectiveness of our patents and different measures to guard our mental property rights; and different elements mentioned in our Quarterly Report on Kind 10-Q for the second quarter of 2024, and in our Annual Report on Kind 10-Ok for the 12 months ended December 31, 2023, together with within the part captioned “Danger Components.” Ahead-looking statements communicate solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different info contained herein, whether or not on account of new info, future occasions or in any other case. You might be cautioned to not put undue reliance on these forward-looking statements.

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¹ Information on file. Parsippany, NJ: Teva Neuroscience, Inc.
² Substance Abuse and Psychological Well being Companies Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed November 2023.
³ Velligan DI, Rao S. The epidemiology and world burden of schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5  
⁴ Wander C. (2020). Schizophrenia: alternatives to enhance outcomes and scale back financial burden by way of managed care. The American journal of managed care, 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013

⁵ Emsley, R., & Kilian, S. (2018). Efficacy and security profile of paliperidone palmitate injections within the administration of sufferers with schizophrenia: an evidence-based evaluate. Neuropsychiatric illness and remedy, 14, 205–223.
⁶ Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The character of relapse in schizophrenia. BMC Psychiatry 13, 50.

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