TEL AVIV, PARSIPPANY - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of seven studies from its long-acting injectable (LAI) schizophrenia research program.

Presentations include data informing clinical strategies for switching patients to UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly intramuscular injection of Invega Sustenna. The results were presented at the Psych Congress Elevate 2024 Annual Meeting taking place from May 30 - June 2 in Las Vegas, Nevada.

'UZEDY is a long-acting formulation of risperidone with an innovative delivery system that requires no loading dose or oral supplementation and can be dosed at one- or two-month intervals to help with prevention of relapse. It is administered subcutaneously under the skin instead of intramuscularly, which is an important feature to discuss with patients,' said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. 'We are proud to share these clinical insights that may help healthcare providers understand more about switching between long-acting options for their schizophrenia patients.'

In a population pharmacokinetic (PopPK) analysis, simulations were performed to predict PK exposures when switching to UZEDY 4 - 6 weeks at steady state after the last injection of once-monthly paliperidone palmitate. Model simulations showed that switching to UZEDY at four weeks after the last dose of once-monthly paliperidone palmitate yielded generally higher PK parameters, both within the total active moiety range for oral risperidone. Comparable doses included UZEDY at 125 mg (once-monthly dosing) or 250 mg (once-every-two-months dosing) to 234 mg of once-monthly paliperidone palmitate. The analysis aims to address the knowledge gap as limited clinical data currently exist to inform strategies for switching between the various available LAI treatment options with differing PK properties.1

Any switching strategy should be determined by clinicians on an individual basis, considering factors such as patient preference, scheduling convenience and potential tolerability issues or risk of symptom breakthrough.

'The treatment and management of schizophrenia is a journey and many patients may see their needs evolve over time due to challenges with symptom control or simply due to a change in dosing preference,' said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. 'Researchers and clinicians like myself rely on analyses like these to understand strategies for switching between long-acting injectable options and help ensure each of our patients is on the most appropriate treatment.'

Additional key data being presented at Psych Congress Elevate 2024:

New data from the RISE (Risperidone Subcutaneous Extended-Release Study) and SHINE (A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia) Phase 3 pivotal studies that supported the FDA approval of UZEDY for adults. The updated analysis evaluated the safety of once or twice monthly UZEDY for young adults (aged 18-21) who participated in the RISE and SHINE studies. No unexpected safety concerns or clinically meaningful trends in adverse events were observed.

Qualitative data from four ADVANCE (Attitudes Driving Regional Differences in LAI Antipsychotic Utilization for Schizophrenia Among Healthcare Professionals, Patients and Caregivers) surveys showing: Ten psychiatrists, who average 18 years of experience and spend 45% of their practice time in hospital-based outpatient clinics, were interviewed and expressed that treatment priorities for patients with schizophrenia may differ depending on the care setting, but all described the potential benefits of LAIs for both patients and clinicians.

Seven psychiatric nurses, who average 17 years of experience and spend 47% of their practice time in outpatient clinics, were interviewed and expressed positive views of LAIs but had a limited understanding of specific LAI molecules and prioritized the benefits of LAIs for nonadherent patients, highlighting potential unmet HCP educational needs.

In the patient and caregiver surveys, 20 patients and 19 caregivers completed a 60-minute interview regarding the use of LAIs in schizophrenia. Most patient-reported perceptions regarding advantages of LAIs were convenience (n=7) and fewer side effects compared with oral antipsychotics (n=3). Caregivers emphasized the importance of a patient's quality of life along with symptom management and expressed advantages of LAIs, including convenience to both the person with schizophrenia and the caregiver (n=10 and n=7, respectively).

Below is the full set of UZEDY and long-acting injectable data presented by Teva at Psych Congress Elevate 2024.

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.2 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.2,3,4 Approximately 1% of the world's population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.4 The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.4 Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.

About UZEDY

UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY significantly reduced the risk of schizophrenia relapse.1,8 UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day.

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 our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize UZEDY (risperidone) extended-release injectable suspension for the treatment schizophrenia; our ability to successfully compete in the marketplace, including our ability to develop and commercialize 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 sustain and focus our portfolio of generics medicines and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned 'Risk Factors.' 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.

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