The systemic security profile of TEV-‘749 was in line with different permitted formulations of olanzapine, with no new security alerts recognized. Further security and tolerability outcomes from Interval 1 (917 lively injections) via week 8 of the SOLARIS research present that:
Commercial 6
Article content material
- There have been no reported circumstances of PDSS.1
- Remedy-emergent hostile occasions that occurred extra typically in sufferers receiving TEV-‘749 versus placebo included weight enhance (35% [173/500] versus 8% [13/167]), injection website induration (13% [64/500] versus 2% [4/167]), injection website ache (10% [50/500] versus 4% [7/167]) and injection website erythema (10% [48/500] versus 1% [1/167]).1
- Critical hostile occasions and discontinuations attributable to hostile 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 Section 1 research of TEV-‘749 present related security and tolerability outcomes, together with no studies of PDSS occasions. Moreover, a offered pre-clinical research means that the subcutaneous route of administration and formulation traits of TEV-‘749 seem to drastically cut back the hypothesized threat 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 research (Interval 2), with security knowledge topline readout anticipated within the first half of 2025.
Commercial 7
Article content material
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 twond era antipsychotic olanzapine and isn’t permitted by any regulatory authority for any use, and its security and efficacy usually are not established.
About Subcutaneous OLAnzapine Prolonged-Launch Injection Research (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled research to judge 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 research (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 shall be at 4 and eight weeks after administration of the final remedy dose, respectively. The first goal of the Section 3 SOLARIS research was to judge the efficacy of TEV-‘749 in grownup sufferers with schizophrenia. A key secondary goal was to additional consider the efficacy of TEV-‘749 based mostly on further parameters in grownup sufferers with schizophrenia. A secondary goal that’s nonetheless ongoing via interval two of the research is to judge the security and tolerability of TEV-‘749 in grownup sufferers with schizophrenia.
Commercial 8
Article content material
About Schizophrenia
Schizophrenia is a persistent, progressive and severely debilitating psychological dysfunction that impacts how one thinks, feels and acts.1 Sufferers expertise an array of signs, which can embody delusions, hallucinations, disorganized speech or habits and impaired cognitive capacity.1,2,3 Roughly 1% of the world’s inhabitants will develop schizophrenia of their lifetime, and three.5 million folks within the U.S. are at present 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 usually 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 threat of lack of perform, remedy refractoriness, and adjustments 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
Commercial 9
Article content material
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a world 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 improvement of contemporary medication. For over 120 years, Teva’s dedication to bettering well being has by no means wavered. At this time, 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 thousands and thousands of sufferers on daily basis. To study 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 creating long-acting injectable medicine 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 scale back their environmental footprint. They mix lively pharmaceutical substances with our proprietary BEPO® expertise which controls the supply of a drug at a therapeutic degree for a number of days, weeks or months from the subcutaneous or native injection of a easy deposit of some millimeters, fully bioresorbable. The primary remedy based mostly on BEPO® expertise, supposed for the remedy of schizophrenia, was permitted by the FDA in April 2023, and is now distributed in the USA by Teva below the identify UZEDY® (BEPO® expertise is licensed to Teva below the identify SteadyTeq™). We collaborate with main pharmaceutical corporations and foundations to enhance world well being via new remedy choices. Primarily based in Montpellier, Medincell at present employs greater than 140 folks representing greater than 25 completely different nationalities. www.medincell.com
Commercial 10
Article content material
Be aware: TEV-‘749 is referenced as mdc-TJK in Medincell’s documentation and company web site.
Cautionary Be aware Concerning Ahead-Trying Statements
This press launch accommodates forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995, that are based mostly 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 possibly can establish these forward-looking statements by way of phrases equivalent to “ought to,” “count on,” “anticipate,” “estimate,” “goal,” “could,” “venture,” “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. Essential elements that might trigger or contribute to such variations embody dangers referring to: our capacity to efficiently develop olanzapine LAI (TEV-‘749) for the remedy of adults with schizophrenia; our capacity to attain profitable outcomes from the Section 3 trial for olanzapine LAI (TEV-‘749), together with the efficacy and security parts; our capacity to efficiently compete within the market, together with our capacity to develop and commercialize further pharmaceutical merchandise; our capacity to efficiently execute our Pivot to Progress technique, together with to profitably commercialize the modern medicines and biosimilar portfolio, whether or not organically or via enterprise improvement; 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 yr ended December 31, 2023, together with within the part captioned “Threat Components.” Ahead-looking statements converse 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 because of new info, future occasions or in any other case. You’re cautioned to not put undue reliance on these forward-looking statements.
Commercial 11
Article content material
________________________
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 cut back financial burden via 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 evaluation. 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.
| IR Contacts | Ran Meir | +1 (267) 468-4475 | |
| Yael Ashman | +972 (3) 914 8262 | ||
| Sanjeev Sharma | +1 (973) 658 2700 | ||
| PR Contacts | Kelley Dougherty Eden Klein |
+1 (973) 832-2810 +972 (3) 906 2645 |
Article content material
