Teva Presents Latest Schizophrenia Portfolio Data Including Real-World Outcomes with UZEDY® (risperidone) Showing Lower Rates of and Longer Time to Relapse Compared to Oral Treatment Options and New Phase 3 SOLARIS Data Showing No Incidence of PDSS…

• Real-world claims studies evaluating UZEDY^® (risperidone) also show improved adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits versus second-generation daily oral options
• Latest Phase 3 SOLARIS data show no suspected or confirmed PDSS events with TEV-'749 after more than 3,400 subcutaneous injections in study participants to date
• As a leader in neuroscience, Teva is committed to researching and developing long-acting treatment options that help address unmet needs for individuals living with schizophrenia
  

/EIN News/ -- PARSIPPANY, N.J. and TEL AVIV, Israel, May 30, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of real-world clinical outcomes, treatment patterns and healthcare resource utilization (HCRU) data evaluating UZEDY^® (risperidone), an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, versus second-generation daily oral options. In the studies, patients receiving UZEDY had lower rates of and longer time to relapse as well as better treatment adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits, shorter hospital length of stay and lower all-cause HCRU. Additionally, Phase 3 SOLARIS data show no incidence of post-injection delirium/sedation syndrome (PDSS) to date in participants taking TEV-'749, a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine. The systemic safety profile was consistent with approved olanzapine options. The data were presented at the 2025 Psych Congress Elevate Annual Meeting, taking place from May 28-31, 2025, in Las Vegas, Nevada.

“People living with schizophrenia and their caregivers face a number of significant daily challenges, including barriers to optimal treatment. For those who struggle adhering to a daily oral regimen, UZEDY may be an appropriate option to help prevent relapse, reduce hospital visits and lower overall costs to the healthcare system,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “With TEV-'749, our latest data demonstrate its potential to fill a critical gap in the current schizophrenia treatment landscape as a long-acting formulation of olanzapine that may effectively address the risk of PDSS.”

UZEDY Data

Two retrospective cohort studies evaluating UZEDY explored claims data comparing outcomes in adults living with schizophrenia who were continuously enrolled in Medicaid, Medicare or commercial health plans.¹ Patients were followed for two years before and six months after starting UZEDY (n=720), second generation oral antipsychotics (SGOA) (n=720) or oral risperidone (n=720).¹ Key findings are summarized below:

Real-World Clinical Outcomes

• UZEDY was associated with a lower relapse rate (9.0% vs. 15.4% for SGOAs and 16.8% for oral risperidone) and a longer mean time to relapse (94 days vs. 61 days for SGOAs and 69 days for oral risperidone).¹
  

Real-World Treatment Patterns and HCRU (UZEDY versus SGOAs)

• A higher percentage of individuals on UZEDY demonstrated good adherence (medication possession ratio ≥0.8; 71.3% vs. 52.8% for SGOAs) and treatment persistence by staying on treatment longer (120 days vs. 96 days for SGOAs).¹
• UZEDY was also associated with shorter hospital stays (8 days vs. 16 days for SGOAs) and lower proportions of patients requiring inpatient (15% vs. 29.6% for SGOAs) or ED visits (22.5% vs. 31.7% for SGOAs). Additionally, patients on UZEDY had fewer outpatient visits (6.3 vs. 8.6 per person/year for SGOAs).¹
• Mean all-cause HCRU costs were lower among adult patients on UZEDY ($18,796 vs. $26,376 for SGOAs).¹
  

TEV-'749 Data

In Period 1 of the SOLARIS trial, TEV-'749 met its primary efficacy endpoint across all three dosing groups (318mg, 425mg, 531mg), with statistically significant mean differences in the change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8 (-9.75 points, -11.27 points, and -9.76 points, respectively) versus placebo.¹ Additional safety results from Period 1 (3,487 active injections) show no suspected or confirmed PDSS events reported as of March 2025.¹ The systemic safety profile of TEV-'749 was consistent with other approved formulations of olanzapine, with no new safety signals identified.¹

With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed SGOAs for schizophrenia around the world. Its efficacy and safety profiles are well established.

Below is the full set of schizophrenia data presented by Teva at Psych Congress Elevate 2025:

UZEDY (risperidone):

• (De novo) Real-World Clinical Outcomes Among Patients Receiving the Long-Acting Injectable Antipsychotic TV-46000 Versus Second-Generation Oral Antipsychotics
• (De novo) Treatment Patterns and Healthcare Resource Utilization Among Patients Receiving the Long-Acting Injectable Antipsychotic TV-46000 Versus Second-Generation Oral Antipsychotics

TEV-'749 (olanzapine):

• (De novo) Olanzapine for Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use Is Designed for Sustained Efficacy and to Eliminate the Risk of Post-injection Delirium/Sedation Syndrome: In Vitro and Clinical Data
• (Encore) Efficacy of Olanzapine Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use Demonstrated in Patients With Schizophrenia: Results From a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial (SOLARIS)
• (De novo) Long-acting Injectable Treatments for Schizophrenia: Differences in Attitudes and Preferences Among Healthcare Professionals and Patients From the SOLARIS Trial Experiences Study
  

Schizophrenia Treatment Landscape:

• (De novo) Clinician Perspectives on the Efficacy and Safety/Tolerability of Olanzapine Compared With Other Antipsychotics: Results From the SONAR (Survey on Olanzapine Needs and Attitudes Research) Study
• (De novo) Real-World Treatment Patterns of Patients With Schizophrenia Using Oral Olanzapine and the Associated Impact of Non-adherence on Healthcare Resource Utilization
• (De novo) Use Of Machine Learning to Identify Variations in Clinical Characteristics, Healthcare Resource Utilization, and Treatment Adherence Among Patients With Schizophrenia Initiating Oral Olanzapine Treatment
• (De novo) Enabling Conversations About Long-Acting Injectable Antipsychotics Among HCPs, Patients, and Caregivers With the Long-Acting Injectables: Conversations and Resources for Education (LAI-CARE)
• (De novo) Perspectives of Psychiatrists and Psychiatric Nonphysicians on Treating Schizophrenia With Long-Acting Injectable Antipsychotics: Subgroup Analysis From Multinational ADVANCE Study
  

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine and is not approved by any regulatory authority for any use, and its safety and efficacy are not established. The long-term safety of TEV-'749 and incidence of PDSS are being evaluated in the SOLARIS open-label study (Period 2).

TEV-'749 and UZEDY utilize SteadyTeq™, a copolymer technology proprietary to MedinCell that provides a controlled steady release of olanzapine and risperidone, respectively.

UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.¹

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.^1,2 UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for rapid 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.² For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-65 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly TEV-'749 (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two, which will last for up to 48 weeks, patients who completed period one are randomized and equally allocated to one of the three TEV-'749 treatment groups.¹ The end-of-treatment and follow-up visits will be at 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of TEV-'749 in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of TEV-'749 based on additional parameters in adult patients with schizophrenia.¹ A secondary objective that is still ongoing through period two of the study is to evaluate the safety and tolerability of TEV-'749 in adult patients with schizophrenia.¹

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.³ Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^3,4,5 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.^4,5 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.⁵ 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.⁵ 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.^6,7,8 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.^3,4,5,6,7,8

INDICATION AND USAGE

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for use in patients with dementia-related psychosis and has not been studied in this patient population.

See below for additional Important Safety Information.

IMPORTANT SAFETY INFORMATION CONTINUED

CONTRAINDICATIONS: UZEDY is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. UZEDY is not approved for use in patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue UZEDY and provide symptomatic treatment and monitoring.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Whether antipsychotic drug products differ in their potential to cause TD is unknown.

The risk of developing TD and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the cumulative dose. The syndrome can develop, after relatively brief treatment periods, even at low doses. It may also occur after discontinuation. TD may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, possibly masking the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

If signs and symptoms of TD appear in a patient treated with UZEDY, drug discontinuation should be considered. However, some patients may require treatment with UZEDY despite the presence of the syndrome. In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response. Periodically reassess the need for continued treatment.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia and diabetes mellitus (DM): in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics, including risperidone. Patients with an established diagnosis of DM who are started on atypical antipsychotics, including UZEDY, should be monitored regularly for worsening of glucose control. Patients with risk factors for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics, including UZEDY, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics, including UZEDY, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics, including UZEDY, should undergo FBG testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic, including risperidone, was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.

Dyslipidemia has been observed in patients treated with atypical antipsychotics.

Weight gain has been observed with atypical antipsychotic use. Monitoring weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D₂ receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension and Syncope: UZEDY may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. UZEDY should be used with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which would predispose patients to hypotension and in the elderly and patients with renal or hepatic impairment. Monitoring of orthostatic vital signs should be considered in all such patients, and a dose reduction should be considered if hypotension occurs. Clinically significant hypotension has been observed with concomitant use of oral risperidone and antihypertensive medication.

Falls: Antipsychotics, including UZEDY, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other fall-related injuries. Somnolence, postural hypotension, motor and sensory instability have been reported with the use of risperidone. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a pre-existing history of a clinically significant low white blood cell count (WBC) or absolute neutrophil count (ANC) or a history of drug-induced leukopenia or neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of UZEDY at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue UZEDY in patients with ANC < 1000/mm³) and follow their WBC until recovery.

Potential for Cognitive and Motor Impairment: UZEDY, like other antipsychotics, may cause somnolence and has the potential to impair judgement, thinking, and motor skills. Somnolence was a commonly reported adverse reaction associated with oral risperidone treatment. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that treatment with UZEDY does not affect them adversely.

Seizures: During premarketing studies of oral risperidone in adult patients with schizophrenia, seizures occurred in 0.3% of patients (9 out of 2,607 patients), two in association with hyponatremia. Use UZEDY cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Antipsychotic drugs, including UZEDY, should be used cautiously in patients at risk for aspiration.

Priapism has been reported during postmarketing surveillance for other risperidone products. A case of priapism was reported in premarket studies of UZEDY. Severe priapism may require surgical intervention.

Body temperature regulation. Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral risperidone use. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may contribute to an elevation in core body temperature; use UZEDY with caution in patients who experience these conditions.

ADVERSE REACTIONS
The most common adverse reactions with risperidone (≥5% and greater than placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

The most common injection site reactions with UZEDY (≥5% and greater than placebo) were pruritus and nodule.

DRUG INTERACTIONS

• Carbamazepine and other strong CYP3A4 inducers decrease plasma concentrations of risperidone.
• Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration.
• Due to additive pharmacologic effects, the concomitant use of centrally-acting drugs, including alcohol, may increase nervous system disorders.
• UZEDY may enhance the hypotensive effects of other therapeutic agents with this potential.
• UZEDY may antagonize the pharmacologic effects of dopamine agonists.
• Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause EPS and/or withdrawal symptoms in neonates with third trimester exposure. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including UZEDY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.

Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and EPS.

Fertility: UZEDY may cause a reversible reduction in fertility in females.

Pediatric Use: Safety and effectiveness of UZEDY have not been established in pediatric patients.

Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 2 mg daily before initiating treatment with UZEDY.

Patients with Parkinson’s disease or dementia with Lewy bodies can experience increased sensitivity to UZEDY. Manifestations and features are consistent with NMS.

Please see the full Prescribing Information for UZEDY, including Boxed WARNING.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. 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 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

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 TEV-‘749 (olanzapine LAI) in adult patients diagnosed with schizophrenia; our ability to successfully develop and commercialize UZEDY (risperidone) extended-release injectable suspension for the treatment of 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, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors and “Forward Looking Statements.” 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.

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. UZEDY (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
3. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia.
4. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
5. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
6. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
7. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
8. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

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