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Tevogen Bio will present positive proof-of-concept trial findings at the 5th Annual Allogeneic Cell Therapies Summit in Boston, MA

  • Tevogen’s ExacTcell platform is designed to produce off-the-shelf, genetically unmodified, allogeneic cytotoxic CD8+ T lymphocyte (CTL) products that can be targeted against malignancies and viruses.
  • TVGN 489 is the first clinical product from Tevogen’s ExacTcell platform.
  • TVGN 489 is an off-the-shelf, genetically unmodified, allogeneic CTL product with precise targets across the SARS-CoV-2 genome.
  • The safety and feasibility of TVGN 489 was successfully tested in high-risk ambulatory patients with COVID-19.

 

WARREN, N.J. — (BUSINESS WIRE) — #ASCGT2023 — Tevogen Bio is pleased to announce that it will present the proof-of-concept clinical trial results of TVGN 489, the company’s first clinical product from its ExacTcell platform, at the 5th Annual Allogeneic Therapies Summit in Boston, MA.


ExacTcell, Tevogen’s precision T cell platform, utilizes CD8+ Cytotoxic T Lymphocytes (CTLs) also known as Killer T Cells, one of nature’s most powerful weapons against cancer and infection. Unlike currently available genetically engineered T cell therapies, the ExacTcell platform is based on careful selection of naturally occurring T cells that recognize targets of interest from the body’s native T cell receptor pool to provide enhanced safety. CD8+ CTLs in ExacTcell based products target multiple and distinct antigens to overcome potential mutational challenges, such as TVGN 489.

 

  • TVGN 489 precisely targets multiple areas across the COVID-19 genome – not just the Spike protein.
  • To date, these TVGN 489 targets, which were identified early in the pandemic, have persisted through the most recent Omicron derived SARS-CoV-2 variants.
  • Conducted at Thomas Jefferson University Hospital in Philadelphia, the trial assessed the safety and feasibility of TVGN 489 when given at one of four escalating doses to patients who were at high-risk for COVID-19-related complications due to their age and other medical conditions.
  • Each patient in the treatment arm received a single infusion of TVGN 489.

 

Positive Proof-of-Concept Clinical Trial Results:

  • No dose-limiting toxicities or significant adverse events related to TVGN 489, including Cytokine Release Syndrome, were observed in any patient at any dose level.
  • Every patient in treatment arm returned to their baseline health status within 14 days.
  • Following TVGN 489 treatment, no incidence of COVID-19 reinfection or Long COVID was observed in any treated patient at the time of the six (6) month follow up.
  • Symptom improvement was reported by all patients receiving TVGN 489 within 2 to 3 days of treatment, which corresponded to a significant decrease in COVID-19 viral load on nasal swab PCR testing in the majority of patients.

 

“TVGN 489 has shown promise as a safe therapy in our proof-of-concept trial, warranting continued development for patients who are vulnerable to poor COVID-19 outcomes, such as the immune-compromised, elderly, and infirm,” stated Dolores Grosso, DNP, the trial’s Principal Investigator.

 

“These proof-of-concept trial results have illustrated the immense potential of Tevogen’s ExacTcell platform, providing a foundation for the future product development for other viral diseases and various cancers. In addition, we are exploring the potential of TVGN 489 for the treatment and prevention of Long COVID,” said Neal Flomenberg, MD, Tevogen’s Chief Scientific Officer.

 

“We believe that cell therapies are expected to be the norm, not the exception,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “Tevogen aspires and is designed to be the very first biotech to achieve commercial success and patient affordability through advanced science and efficient business models.”

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple, precise candidate targets on viral or malignant cells are selected in advance for T cell sensitization and effector functions with the goal of overcoming the mutational escape capacity of cancer cells and viruses while limiting cross-reactivity.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to provide access to the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections. The ability to administer TVGN-489 in the outpatient setting and the ongoing work by Tevogen scientists to use this product in diverse patient populations, highlights Tevogen Bio’s commitment to patient accessibility.

 

About Tevogen Bio

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company)” and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 701

Communications@Tevogen.com

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Healthcare Lifestyle Programs & Events Science

Teva to present data demonstrating UZEDY™ (risperidone) extended-release injectable suspension significantly prolonged time to impending relapse for adults with schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting

  • UZEDY significantly reduced the risk of relapse by up to 80% and prolonged the time to impending relapse by up to 5.0 times while having a similar safety profile to other formulations of risperidone1,2
  • The U.S. Food and Drug Administration (FDA) approved UZEDY on April 28, 2023 for the treatment of schizophrenia in adults as a subcutaneous injection every one or two months using a pre-filled syringe
  • Symposia on IMPACT-TD scale for tardive dyskinesia (TD) progression measurement and clinical education tool for schizophrenia, S.C.O.P.E., are also to be presented

 

TEL AVIV, Israel & PARSIPPANY, N.J. — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced that four studies across its neuroscience portfolio will be presented during the American Psychiatric Association’s (APA) 2023 Annual Meeting taking place on May 20-24, 2023. Abstracts include data for UZEDY (risperidone) extended-release injectable suspension for subcutaneous use, which was recently approved by the FDA for the treatment of schizophrenia in adults. Additional abstracts being presented include data on characteristics that impact TD diagnosis and machine-learning to identify unique patient segments for TD. TD is a chronic movement disorder that affects one in four people who take certain mental health treatments.3-5

Of the data being presented, Teva will share findings from two trials that supported the FDA approval of UZEDY, the RISE Study (The Risperidone Subcutaneous Extended-Release Study) and the SHINE Study (A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).6,7 The RISE data demonstrated that UZEDY significantly prolonged time to impending relapse by 5.0 (once-monthly dosing) and 2.7 (once-every-two-months dosing) times versus placebo in patients with schizophrenia.2 Additionally, the SHINE data confirmed the safety profile of UZEDY is consistent with other formulations of risperidone.2

 

“We’re pleased to present the foundational data that supported the FDA’s approval of UZEDY,an important new treatment option for adults with schizophrenia,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “We know schizophrenia patients experience a number of challenges when it comes to this condition, and are optimistic that UZEDY can help address the unmet needs of patients, their caregivers, and physicians.”

 

Findings from the RISE and SHINE studies demonstrate that UZEDY is efficacious with the known safety profile of risperidone. The innovative long-acting formulation of UZEDY allows for both absorption and sustained release after subcutaneous injection and is available with a range of dosing options. UZEDY utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell, that controls the rate and duration of risperidone release. With this delivery system, therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

 

In addition to the data, Teva will also be holding a symposium on the newly developed IMPACT-TD scale, featuring Richard Jackson, MD, Assistant Clinical Adjunct Professor, University of Michigan School of Medicine Department of Psychiatry, that may help better measure disease progression of those living with TD by taking a holistic approach to tracking social, vocational, psychological and psychiatric challenges the condition poses over time. A symposium on S.C.O.P.E. featuring John Kane, MD, Professor and Chairman, Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, will also be presented – an educational tool for schizophrenia that helps teach physicians about common myths and misconceptions, manage frequent clinical dilemmas and identify the latest therapeutic options.

 

This year’s annual APA meeting is being offered both in person and virtually. Abstracts can be accessed here.

 

The full set of data sponsored by Teva includes:

Symposium: Saturday, May 20, 2:00 PM – 3:00 PM PT

  • Guiding the S.C.O.P.E. of schizophrenia care forward through interactive digital education for clinicians

Symposium: Monday, May 22, 12:15 PM – 12:45 PM PT

  • IMPACT-TD scale: A novel tool to assess the true story of the impact of TD in our patients

Poster Session 12: Tuesday, May 23, 1:30 PM – 3:00 PM PT

  • (De novo) Use of Machine-Learning to Identify Unique Patient Segments Within the Tardive Dyskinesia Population (5040)
  • (De novo) Assessment of Underdiagnosis of Tardive Dyskinesia (TD) by Geographic Region, Social Determinants, and Other Patient Characteristics (4939)

Poster Session 13: Tuesday, May 23, 3:45 PM – 5:15 PM PT

  • (De novo) TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA) in Schizophrenia: Phase 3 Study (RISE) and Long-Term Safety and Tolerability Study (SHINE) (5523)
  • (De novo) Myths, Misconceptions, and Clinical Dilemmas Surrounding the Use of Long-acting Injectable Antipsychotic Agents for Treatment of Schizophrenia (4779)

About Tardive Dyskinesia (TD)

Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.3-5

 

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.8 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.8-10 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.9,10 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.8 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.8 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.11-13 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.8-13

 

About UZEDY

UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY reduced the risk of relapse by up to 80%.1 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.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

 

INDICATION AND USAGE

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

IMPORTANT SAFETY INFORMATION

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.

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) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at 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 the development and commercial success of 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 competition for our innovative medicines, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

________________________

1 UZEDY™ (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.

2 Kane J, Sharon N. TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA) in Schizophrenia: Phase 3 Study (RISE) and Long-Term Safety and Tolerability Study (SHINE). American Psychiatric Association’s 2023 Annual Meeting; 2023. May 20-24. Hybrid congress.

3 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258.

4 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.

5 Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 4, 2023.

6 “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia. ClinicalTrials.gov, U.S. National Institutes of Health, 2018 (NCT03503318).

Contacts

IR Contacts
Ran Meir +1 (267) 468-4475

Yael Ashman, +972 (3) 914 8262

Sanjeev Sharma +1 (973) 658 2700

PR Contacts
Kelley Dougherty +1 (973) 832-2810

Eden Klein +972 (3) 906 2645

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Healthcare Science

Legend Biotech to demonstrate progress in advancing potential treatment options for patients with multiple myeloma at ASCO and EHA Annual Meetings

  • Eight presentations at ASCO and EHA 2023 Annual Meetings showcase continued leadership in CAR-T cell therapy research for patients with multiple myeloma across various clinical settings
  • First analysis from the CARTITUDE-4 Phase 3 study in relapsed and lenalidomide-refractory multiple myeloma patients with one to three earlier lines of therapy to be presented as an oral presentation at ASCO and in a plenary session at EHA
  • Data from the final analysis of the CARTITUDE-1 study

 

SOMERSET, N.J. — (BUSINESS WIRE) — $LEGN–Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that new and updated data from the CARTITUDE Clinical Development Program evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association’s (EHA) 2023 Hybrid Congress. Five-year follow-up data from Legend-2 (NCT03090659), an investigator-initiated trial that has been assessing a similar CAR construct since 2015, will also be presented at the meetings.

 

From the CARTITUDE Clinical Development Program, the first analysis of the Phase 3 CARTITUDE-4 study was accepted as a late breaking abstract at ASCO and will be presented as an oral presentation at both ASCO and in a plenary session at EHA. CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study investigating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received cilta-cel vs standard-of-care regimens, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), following one to three prior lines of therapy.

 

“We are pleased that the latest data from the CARTITUDE-4 study will be officially presented at the meetings. We are continuing to investigate cilta-cel in earlier lines of treatment and the readout from this study is crucial to how we move forward,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We also eagerly anticipate the presentation of the five-year follow-up data from Legend-2 at ASCO. This was the study that showed — in front of the international community back in 2017 —promising results in heavily pretreated patients with multiple myeloma. Since then, we have taken significant steps toward advancing the treatment landscape for myeloma patients in the CARTITUDE Development Program and are exploring the potential of other agents in our pipeline for this and other indications.”

Additional data at this year’s meetings will include longer-term results from the final protocol-specified analysis of the CARTITUDE-1 study (NCT03548207), which will be shared as a poster presentation at ASCO and an oral presentation at EHA. CARTITUDE-1 is a Phase 1b/2 study evaluating cilta-cel for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma. The study’s 18-month follow-up data supported the U.S. Food and Drug Administration (FDA) approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in February 2022.

 

Data from the 5-year follow-up analysis of LEGEND-2 will be presented as a poster at ASCO and EHA. This first-in-human, Phase 1 study evaluates LCAR-B38M CAR-T cells in patients with relapsed and refractory multiple myeloma. It is the longest follow-up for any BCMA-targeted CAR-T cell therapy study to be presented at the meetings.

 

A select list of abstracts from the meetings can be found below.

 

ASCO Presentations (June 2-6, 2023)

Abstract Number

Title

Information

Abstract #106

Oral Presentation

First Phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma

Session Title: Clinical Science Symposium – Moving Cellular Therapy into Earlier Lines of Treatment in Hematologic Malignancies: Latest Efficacy Data and The Need to Improve Access

Date/Time: June 5, 2023, 9:45 am – 11:15 am CDT

Location: Hall D1 & On Demand

Abstract #8009

Poster Discussion

CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

Date/Time: June 5, 2023, 8:00 am – 11:00 am CDT (poster), 3:00 pm – 4:30 pm (discussion)

Location: Hall A & On Demand

Abstract #8010

Poster Discussion

Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T – at least 5-year follow-up in LEGEND-2

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

Date/Time: June 5, 2023, 8:00 am – 11:00 am CDT (poster), 3:00 pm – 4:30 pm (discussion)

Location: Hall A & On Demand

EHA Presentations (June 8-11, 2023)

Abstract Number

Title

Information

Abstract #P904

Poster Presentation

LocoMMotion: A prospective, observational, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma – final analysis at 2-year follow-up

Friday June 9, 2023

18:00 – 19:00 CEST

Abstract #S100

Plenary Session

Encore: First Phase 3 results from CARTITUDE-4: cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma

Saturday June 10, 2023

14:45-15:00 CEST

Abstract #S202

Oral Presentation

Encore: CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma

Sunday, June 11, 2023

12:00 –12:15 CEST

Abstract #P874

Poster Presentation

Encore: Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T – at least 5-year follow-up in LEGEND-2

Friday June 9, 2023

18:00 – 19:00 CEST

Abstract #P922

Poster Presentation

Adjusted comparisons of ciltacabtagene autoleucel with therapies from real-world clinical practice: two-year follow-up analysis from CARTITUDE-1 and the prospective LocoMMotion study

Friday, June 9, 2023

18:00 – 19:00 CEST

 

ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)

Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1

 

In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.

In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma.2 In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma.3 In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®.4 Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.5

 

ABOUT CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.

 

ABOUT CARTITUDE-4

CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

 

ABOUT LEGEND-2

LEGEND-2 (NCT03090659) is a single arm, open-label, multi-center, Phase 1/2 study, to determine the safety and efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma.

 

ABOUT LOCOMMOTION

LocoMMotion (NCT04035226) is a prospective, multinational, observational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma who received at least 3 prior lines of therapy including a PI, IMiD and CD38 monoclonal antibody treatment.

ABOUT MULTIPLE MYELOMA

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.6 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Although treatment may result in remission, unfortunately, patients will most likely relapse.9 Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.10,11

 

CARVYKTI® INDICATIONS AND USAGE

CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

 

CARVYKTI® IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, and PROLONGED and RECURRENT CYTOPENIA

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed.

Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities.

Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®.

CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS Program.

 

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI® in 95% (92/97) of patients receiving ciltacabtagene autoleucel. Grade 3 or higher CRS (2019 ASTCT grade) occurred in 5% (5/97) of patients, with Grade 5 CRS reported in 1 patient. The median time to onset of CRS was 7 days (range: 112 days). The most common manifestations of CRS included pyrexia (100%), hypotension (43%), increased aspartate aminotransferase (AST) (22%), chills (15%), increased alanine aminotransferase (ALT) (14%) and sinus tachycardia (11%). Grade 3 or higher events associated with CRS included increased AST and ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, respiratory failure, acute kidney injury, disseminated intravascular coagulation and hemorrhage, HLH/MAS, angina pectoris, supraventricular and ventricular tachycardia, malaise, myalgias, increased Creactive protein, ferritin, blood alkaline phosphatase and gamma-glutamyl transferase.

 

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. One patient with CRS and suspected HLH/MAS developed a fatal retroperitoneal hemorrhage in the setting of thrombocytopenia, coagulopathy and anticoagulation.

 

Sixty-nine of 97 (71%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of ciltacabtagene autoleucel. Forty-four (45%) patients received only tocilizumab, of whom 33 (34%) received a single dose and 11 (11%) received more than one dose; 24 patients (25%) received tocilizumab and a corticosteroid, and one patient (1%) received only corticosteroids. Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI®.

Monitor patients at least daily for 10 days following CARVYKTI® infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.

 

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

 

Neurologic toxicities, which may be severe, life-threatening or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, Guillain-Barré Syndrome, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.

 

Overall, one or more subtypes of neurologic toxicity described below occurred following ciltacabtagene autoleucel in 26% (25/97) of patients, of which 11% (11/97) of patients experienced Grade 3 or higher events. These subtypes of neurologic toxicities were also observed in two ongoing studies.

 

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. ICANS occurred in 23% (22/97) of patients receiving ciltacabtagene autoleucel including Grade 3 or 4 events in 3% (3/97) and Grade 5 (fatal) events in 2% (2/97). The median time to onset of ICANS was 8 days (range 1-28 days). All 22 patients with ICANS had CRS. The most frequent (≥5%) manifestation of ICANS included encephalopathy (23%), aphasia (8%) and headache (6%).

 

Monitor patients at least daily for 10 days following CARVYKTI® infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

 

Parkinsonism: Of the 25 patients in the CARTITUDE-1 study experiencing any neurotoxicity, five male patients had neurologic toxicity with several signs and symptoms of parkinsonism, distinct from immune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity with parkinsonism has been reported in other ongoing trials of ciltacabtagene autoleucel. Patients had parkinsonian and non-parkinsonian symptoms that included tremor, bradykinesia, involuntary movements, stereotypy, loss of spontaneous movements, masked facies, apathy, flat affect, fatigue, rigidity, psychomotor retardation, micrographia, dysgraphia, apraxia, lethargy, confusion, somnolence, loss of consciousness, delayed reflexes, hyperreflexia, memory loss, difficulty swallowing, bowel incontinence, falls, stooped posture, shuffling gait, muscle weakness and wasting, motor dysfunction, motor and sensory loss, akinetic mutism, and frontal lobe release signs. The median onset of parkinsonism in the 5 patients in CARTITUDE-1 was 43 days (range 15-108) from infusion of ciltacabtagene autoleucel.

 

Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease, for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.

 

Guillain-Barré Syndrome: A fatal outcome following Guillain-Barré Syndrome (GBS) has occurred in another ongoing study of ciltacabtagene autoleucel despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances and polyradiculoneuritis.

 

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

 

Immune Mediated Myelitis: Grade 3 myelitis has occurred 25 days following treatment in another ongoing study. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

 

Peripheral Neuropathy: Six patients in CARTITUDE-1 developed peripheral neuropathy. These neuropathies presented as sensory, motor or sensorimotor neuropathies. Median time of onset of symptoms was 62 days (range 4-136 days), median duration of peripheral neuropathies was 256 days (range 2-465 days) including those with ongoing neuropathy. Patients who experienced peripheral neuropathy also experienced cranial nerve palsies or GBS in other ongoing trials of ciltacabtagene autoleucel. Monitor patients for signs and symptoms of peripheral neuropathies.

 

Cranial Nerve Palsies: Three patients (3.1%) experienced cranial nerve palsies in CARTITUDE-1. All three patients had 7th cranial nerve palsy; one patient had 5th cranial nerve palsy as well. Median time to onset was 26 days (range 21-101 days) following infusion of ciltacabtagene autoleucel. Occurrence of 3rd and 6th cranial nerve palsy, bilateral 7th cranial nerve palsy, worsening of cranial nerve palsy after improvement, and occurrence of peripheral neuropathy in patients with cranial nerve palsy have also been reported in ongoing trials of ciltacabtagene autoleucel. Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Fatal HLH occurred in one patient (1%), 99 days after ciltacabtagene autoleucel. The HLH event was preceded by prolonged CRS lasting 97 days. The manifestations of HLH/MAS include hypotension, hypoxia with diffuse alveolar damage, coagulopathy, cytopenia, and multi-organ dysfunction, including renal dysfunction.

 

One patient with grade 4 HLH/MAS developed fatal intracerebral and gastrointestinal hemorrhage in the setting of coagulopathy and thrombocytopenia 12 days after treatment in another ongoing study. Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematological parameters in patients with HLH/MAS and transfuse per institutional guidelines.

 

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

 

CARVYKTI® REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS.

 

Further information is available at https://www.carvyktirems.com/ or 1-844-672-0067.

 

Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. One patient underwent autologous stem cell therapy for hematopoietic reconstitution due to prolonged thrombocytopenia.

 

In CARTITUDE-1, 30% (29/97) of patients experienced prolonged Grade 3 or 4 neutropenia and 41% (40/97) of patients experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Day 30 following ciltacabtagene autoleucel infusion.

 

Recurrent Grade 3 or 4 neutropenia, thrombocytopenia, lymphopenia and anemia were seen in 63% (61/97), 18% (17/97), 60% (58/97), and 37% (36/97) after recovery from initial Grade 3 or 4 cytopenia following infusion. After Day 60 following ciltacabtagene autoleucel infusion, 31%, 12% and 6% of patients had a recurrence of Grade 3 or higher lymphopenia, neutropenia and thrombocytopenia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Eighty-seven percent (84/97) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia.

Contacts

PRESS CONTACT:
Tina Carter, Corporate Communications Lead, Legend Biotech

tina.carter@legendbiotech.com
(908) 331-5025

INVESTOR CONTACTS:
Joanne Choi, Senior Manager, Investor Relations, Legend Biotech

joanne.choi@legendbiotech.com

Crystal Chen, Manager, Investor Relations, Legend Biotech

crystal.chen@legendbiotech.cn

Read full story here

Categories
Farewell Services Healthcare Lifestyle

Member of Dryden family legacy and empire recently passed

The late Delaine Dryden, mid 50s, died recently of cancer. Dryden was a medical clerk, who enjoyed life,  family and friends. She battled her illness for years before succumbing. She was really very loved, and was surrounded by family and friends during her struggle.

 

She is survived by two brothers, Cliff Dryden and Steve Dryden; and her sister, Jascent Dryden. Her mother Norma Dryden is also a survivor. She leaves behind aunts, cousins, nieces, friends, and many others.

 

Funeral services were held at Gilmore Funeral Home in Queens, N.Y., on Friday, March 10. They were followed by a repast at Antun’s in Queens Village. The burial procession was on Saturday, March 11 at Pine Lawn Cemetery in Farmingdale, N.Y. Reception and gathering for church services were at Holy Trinity Church in Cambria Heights, N.Y.

Categories
Healthcare Lifestyle Regulations & Security Science

FDA seeks to solve clinical trial delays by accelerating patient recruitment

The entire research, development, and approval process of a new drug by the Food and Drug Administration (FDA) can range between 12 to 15 years.

 

Drug companies seeking to sell a drug in the U.S. must first test it and then send it to the Center for Drug Evaluation and Research (CDER), following which a team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling, and subsequently approves the drug if the benefits outweigh the risks. After approval, the researcher can begin clinical trials on volunteers.

 

Phase 1 trials determine medication safety and dosing in 20-100 individuals, while Phase 2 trials assess safety and performance in several hundred individuals. Phase 3 trials further assess safety, performance, and side effects in 300-3,000 individuals. Only about 25% of medications move forward in the FDA approval process after Phase 3 trials.

 

“There are several persistent challenges and pitfalls in bringing new drugs to the market. For proper planning and risk mitigation, the clinical trial operational strategy needs to begin six to nine months before the trial begins. It needs to be a front-loaded effort to minimize the biggest risk factors first,” says Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, a company that specializes in significantly accelerating the process of bringing new medicines or vaccines to patients who need them.

 

Based on studies, patient recruitment issues are the cause of 85% of clinical trial delays, with 80% of trials being delayed by at least a month. Each day of delay potentially costs between $600,000 and $8 million in lost revenues.

 

Clinical trial recruitment faces several challenges at the site level, such as outdated patient databases, and failure to enroll patients because of complex eligibility criteria. Other challenges include unqualified or unresponsive patients, patient location, and lack of interest.

 

“Persistent pain points plague every clinical trial, such as the inevitable protocol amendments that need to be planned for rather than reacting to them as a surprise—which can exponentially delay the process and increase the costs. Clinical Trial operations need to be focused on the right aspects at the right time, especially up front,” explains Dr. Rajasimha.

 

Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics can speak on the following:

  • What are the different phases of the drug approval process by the FDA?
  • What are the challenges in bringing new drugs to market?
  • What are the persistent challenges faced in clinical trials for the testing of drugs?
  • What are the factors that affect clinical trial recruitment and participation?

 

About Jeeva Informatics

The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/

 

 

To speak with Dr. Harsha Rajasimha, contact me via khelms@jotopr.com or call 727-777-4619

Media Inquiries:

Karla Jo Helms

JOTO PR™

727-777-4619

jotopr.com

Categories
Healthcare Lifestyle Science

Experts say ergonomics crucial in combating musculoskeletal disorders

Musculoskeletal Disorders

The World Health Organization reports that musculoskeletal conditions affect approximately 1.71 billion individuals worldwide, and are the leading cause of disability globally, with low back pain being the single leading cause of disability in 160 countries.

 

Disabling musculoskeletal conditions affect approximately 127.4 million people in the U.S., which is over a third of the U.S. population.

 

Musculoskeletal care accounts for one-sixth of employer-sponsored plan dollars and a $600 billion expense to the U.S. economy.

 

The pain can lead to the joints being affected, leading to osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, and spondylarthritis. In addition, bones may also be affected by osteoporosis, osteopenia, and associated fragility fractures or traumatic fractures. Chronic musculoskeletal disorders may also lead to depression, anxiety, and decreased quality of life.

 

Some of the causes of musculoskeletal disorders are poor posture while sitting and working long hours – a condition prevalent among dental surgeons and ENT specialists.

 

“A good dental provider does everything they can to relax their patients during any dental procedure, frequently at the expense of their own physical well-being. Dentists and hygienists assume awkward postures while performing repetitive tasks, positioning themselves rigidly to maintain precise movements to minimize patient discomfort,” notes Adrian LaTrace, CEO of Boyd Industries, the market leader in the design and manufacture of highly reliable, innovative dental and medical operatory equipment.

 

People suffering from musculoskeletal pain tend to miss out on work for an average of 8.2 days, which is double the sick days of an average worker. This figure goes up to 13 days for individuals with musculoskeletal pain and mental health needs.

 

Experts suggest good ergonomics are a necessity to protect against musculoskeletal disorders. The aim of ergonomics is to alleviate stress and eradicate injuries and disorders linked to improper posture and alignment, muscle overuse, and repetitive movements. Proper workplace ergonomics reduce musculoskeletal problems by 61% and lost workdays by 88%.

 

“Workplace ergonomics in the dental industry needs to be ubiquitous, from the front desk to the treatment chair and surrounding dental operatory equipment. The benefits of an ergonomic office depend upon the individual needs of each member of the entire team,” emphasizes LaTrace.

Adrian LaTrace, CEO of Boyd Industries can speak on the following:

  • What are the factors leading to the increase in musculoskeletal disorders?
  • What are some of the conditions that may result from musculoskeletal pain?
  • Which professions are most prone to musculoskeletal disorders?
  • How can ergonomics help in reducing the risks of musculoskeletal disorders?
  • What are the benefits of proper ergonomics in the workplace?

About Boyd Industries
For 65 years, Boyd Industries has been the innovative market leader in the design and manufacture of dental and medical operatory equipment. Their high-quality and reliable equipment has been the choice of dental specialty practices and dental surgery offices. The rapidly expanding Ear, Nose, and Throat market now seeks its reputation for quality and innovation. Boyd equipment is specifically designed to provide maximum practice productivity while incorporating ergonomic characteristics for the doctor, staff, and patient. As an original equipment manufacturer, they use a vertically integrated approach to ensure their process meets high-quality standards. This approach allows Boyd to control each step of component fabrication and product assembly. Boyd’s products include a full line of dental exam, treatment and surgical chairs, dental delivery systems, LED exam and surgical lighting, custom sterilization and storage cabinetry, doctor or assistant seating, and other accessories. Boyd was named the Senate Small Business of the Week in November 2020 and is a ten-time winner of the Townie Choice Award for excellence in orthodontic operatory equipment. Built to last. Built for you. Built by Boyd.

Categories
Business Healthcare Lifestyle Science

DWK Life Sciences completes acquisition of Assem-Pak | Aluseal

WERTHEIM, Germany — (BUSINESS WIRE) — DWK Life Sciences (“DWK”), a leading global manufacturer and supplier of laboratory glassware, plasticware, and primary packaging solutions, has completed the acquisition of Assem-Pak | Aluseal (“Assem-Pak”), a U.S. company based in Vineland, New Jersey.

 

Assem-Pak, which was founded 23 years ago and currently employs 110 people at their New Jersey facility, specializes in the production of premium rubber stoppers and aluminum seals as well as premium services such as washing, cleaning, assembling, and kitting of primary packaging for the Life Science market.

The acquisition will allow DWK to broaden its range of customizable packaging solutions for the Life Science industry segment, enabling it to support customers at every critical step of their development process. Assem-Pak also strengthens DWK’s value proposition of providing bundled solutions, allowing organizations to consolidate and simplify their complex supply chains.

 

DWK’s recent investments in its plants in Rockwood (U.S.) and Holzminden (Germany) have increased its manufacturing capability for glass vials across the U.S. and Europe. With the addition of Assem-Pak, DWK continues its expansion plan to further strengthen its presence in the Life Science packaging solutions market.

 

“I’m excited that Assem-Pak has joined the DWK family to enhance our vision of being a leading packaging solutions provider. Assem-Pak’s combination of manufacturing expertise and service offerings is a great addition to our already extensive global production and service footprint. This acquisition will allow DWK to capitalize on increasing demand for custom solutions to meet the complex needs of the Life Science industry,” said Armin Reiche, CEO of DWK Life Sciences.

 

Jeff Schempp, CEO of DWK Life Sciences LLC (North America) added: “The combination of Assem-Pak’s manufacturing capabilities in rubber stoppers and aluminum seals combined with DWK’s global market access makes this a perfect fit for both companies. We’re happy to have a great team join the DWK Group to help us achieve our objectives for years to come.”

 

About DWK Life Sciences

DWK Life Sciences is the leading global manufacturer and provider of precision labware as well as primary packaging solutions for Life Science Research, Applied Sciences and Diagnostics, and Pharmaceutical markets.

 

With over 35,000 products, the company’s offering includes the most comprehensive range of premium laboratory glassware together with a complementary portfolio of plastic products. They are manufactured at 12 global sites and marketed under the acclaimed brands DURAN®, WHEATON®, and KIMBLE®.

 

Worldwide, our 1,900 employees are dedicated to developing and delivering superior products and services to meet the highest expectations of customers in laboratories and production environments around the world. To learn more, visit www.DWK.com.

 

DWK Life Sciences is a portfolio company of One Equity Partners.

 

About One Equity Partners

One Equity Partners (“OEP”) is a middle market private equity firm focused on the industrial, healthcare, and technology sectors in North America and Europe. The firm seeks to build market-leading companies by identifying and executing transformative business combinations. OEP is a trusted partner with a differentiated investment process, a broad and senior team, and an established track record generating long-term value for its partners. Since 2001, the firm has completed more than 300 transactions worldwide. OEP, founded in 2001, spun out of JP Morgan in 2015. The firm has offices in New York, Chicago, Frankfurt and Amsterdam. For more information, please visit www.oneequity.com.

Contacts

Cortney Ecklor, Digital Marketing Manager

cortney.ecklor@dwk.com
phone: 865.399.6047

Categories
Economics Healthcare Lifestyle Local News

Trenton employees receive a boost in healthcare

A Partnership with Healthcare2U Provides City Staff with Direct Primary Care Membership

 

AUSTIN, TX.  — City of Trenton employees are now benefiting from an enhanced healthcare plan.

 

The plan provides a Direct Primary Care (DPC) membership to city staff and aims to ensure that a visit to a doctor is affordable and accessible. Following a statewide increase in health premiums for state employees, Trenton sought options to ensure those costs remained low. As a result, they opted for a self-funded insurance plan through Aetna that included Healthcare2U’s DPC membership. This move is expected to save the city $4.3 million annually.

 

The added Healthcare2U DPC membership gives employees an excellent option for affordable access to physicians and internists. With an out-of-pocket cost of $0 for virtual primary care, $10 for an in-office acute consultation, and $25 for urgent care, the city believes this encourages employees to maintain a regular check-up routine while reducing overall claims costs.

 

“Our direct primary care model is the only one of its kind in the nation. We are in all 50 states and thanks to the brokers who see us as a valuable addition to their portfolio, we are quickly expanding throughout New Jersey,” said Andy Bonner, CEO of Healthcare2U. “Our team works with members to facilitate timely and frequent access to medical care that can be essential to the early detection of a serious condition.”

 

“We’re fortunate to be partnering with Healthcare2U for city staff with direct primary care membership, which helps to ensure that all of our city employees can access timely, affordable, and essential health services,” said Mayor Reed Gusciora. “We are projected to save millions of dollars through our new insurance policy and we’re so grateful to all of our partners for helping to make this a reality.”

 

DPC is not meant to be a substitute for major medical insurance, but it does have its advantages. The low cost of an office visit with DPC is meant to prompt individuals to see a doctor more often and avoid developing a serious complication with an unaddressed or undiagnosed issue. In addition to acute and urgent care visits, the plan offers:

  • Unlimited access to bilingual licensed medical providers online or by phone, 24/7/365 for minor illnesses and injuries at $0 out-of-pocket cost to members
  • Annual physical with four labs: complete metabolic panel (CMP), complete blood count (CBC), thyroid-stimulating hormone (TSH), and lipid panel
  • Unlimited chronic disease management for 13 prevalent chronic disease states within manageable ranges.

Healthcare2U partners with third-party administrators, carriers, and brokers to provide their clients with the DPC membership as a non-insurance alternative. These partnerships also allow Healthcare2U the unique opportunity to embed its services into valuable solutions that are available for wide distribution in the marketplaces.

 

Membership with the City of Trenton is established through Healthcare2U’s partnership with   Fairview Insurance.

About Healthcare2U

Healthcare2U is a membership-based, hybrid direct primary care (DPC) organization that ensures employers of all sizes and structures have nationwide access to affordable, consistent, and quality primary care over 40% below the average cost of traditional DPC practices operating in the market today. Through our proprietary Private Physician Network (PPN)™, Healthcare2U promotes healthy living by detecting, treating, and managing acute and chronic conditions before the onset of serious illness. Healthcare2U is headquartered in Austin, Texas, and is available nationwide. For more information, visitwww.healthc2u.com. Follow us on Twitter @Healthc2U and on LinkedIn at Healthcare2U. 

About Fairview Insurance

Fairview Insurance is a full-service insurance agency based in Verona and Cherry Hill, New Jersey. Working on behalf of individuals, companies, and public entities, we provide customized insurance plans, employee benefits, and financial planning services. Our longevity and depth of experience have fostered a solid reputation for friendly, personal service that forms the core of our success.

 

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Healthcare Lifestyle Science

Blue Earth Diagnostics announces additional results from phase 3 SPOTLIGHT trial of investigational PET imaging agent 18F-rhPSMA-7.3 in biochemical recurrence of prostate cancer

− Results at the American Urological Association’s 2023 Annual Meeting (AUA2023) –

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced additional results from its completed Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer, among a subgroup of patients who had undergone primary treatment with radiation therapy only.

 

It evaluated the overall Detection Rates (DRs) of 18F-rhPSMA-7.3 at patient level and stratified by anatomical region, Gleason score, baseline Prostate Specific Antigen (PSA) levels and PSA doubling time. 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in a moderated poster presentation at the American Urological Association’s 2023 Annual Meeting (AUA2023), in Chicago, Ill.


“The ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management for these men is key for physicians and their patients, because up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Brian T. Helfand, MD, Chief of Division of Urology, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group.

 

“The utility of conventional imaging for the localization of recurrence is limited, and relapse after curative-intent radiation therapy remains a considerable clinical burden. Precise imaging techniques are required to identify areas of involvement in order to facilitate delivery of optimized management for patients. These findings from the Phase 3 SPOTLIGHT subgroup study showed high detection rates by majority read for 18F-rhPSMA-7.3 across all regions. In particular, the finding that 43% (33/76) of men had distant extra-pelvic recurrences has important implications for clinical management, as procedures such as salvage prostatectomy would be futile in those cases.”

 

“These results from the Phase 3 SPOTLIGHT trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging currently under review by the U.S. Food and Drug Administration, and we are pleased that they are being presented to the urology community at AUA 2023,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity. The compound is part of Blue Earth Diagnostics’ comprehensive prostate cancer portfolio, which includes other compounds and this investigational rhPSMA compound for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy.”

 

The findings presented at AUA included analyses of clinical factors impacting DRs for 18F-rhPSMA-7.3 as evaluated by three blinded central readers: DRs, overall patient-level detection rate, and regional-level analyses, stratified by Gleason score, baseline PSA levels and PSA doubling time. For example, results showed that among the subgroup (n=76) of patients in the Evaluable PET Scan Population who had undergone primary treatment with radiation therapy for prostate cancer, the overall patient-level DR was 99% (75/76) and consistently high across the three independent readers (range 93-99%). Recurrence by region was 76% (58/76) for the prostate, 25% (19/76) for pelvic lymph nodes and 43% (33/76) for extra-pelvic recurrences. As noted previously, no serious adverse reactions were attributed to 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Of the 391 patients who received 18F-rhPSMA-7.3 in the SPOTLIGHT study, 16 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2).

 

The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO GU in February 2022,1 with additional results announced at AUA in April 20222, at SNMMI in June 20223 and at ASTRO in October 20224.

 

The findings were discussed in a moderated poster presentation at AUA 2023 on April 29, 2023, “18F-rhPSMA-7.3 Detection Rates in Patients with Recurrence of Prostate Cancer Following Primary Treatment with Radiation Therapy: Results SPOTLIGHT Study,” by Brian T. Helfand, MD, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group. Full session details and the abstract are available in the AUA online program HERE.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

 

1Schuster, DM, SPOTLIGHT Study Group, J. Clin. Onc. 2022; 40 (6_suppl):9-9.

2Fleming, MT, SPOTLIGHT Study Group, J. Urol. 2022; 207 (5_suppl):31047.

3Kuo, P, SPOTLIGHT Study Group, J. Nucl. Med. 2022; 63 (2_suppl):2539.

4Lowentritt, B, SPOTLIGHT Study Group, Int. J. Radiat. Oncol. Biol. Phys. 2022; 114(3):S130-S131.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Healthcare Lifestyle Science

Teva and MedinCell announce FDA approval of UZEDY™ (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults

  • This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1
  • In a Phase 3 clinical trial, UZEDY demonstrated up to 80% reduction in risk of schizophrenia relapse versus placebo1
  • UZEDY is a subcutaneous injection from a pre-filled syringe with a 21-gauge needle

 

PARSIPPANY, N.J. & TEL AVIV & PARIS — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults.

 

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

“UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva. “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.”

 

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment,2 most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.3,4

Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts.5 This approval is based on data from two Phase 3 trials evaluating UZEDY in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

 

“The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell. “We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders.”

 

The use of novel SteadyTeq technology in UZEDY controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

 

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia,6 so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY. “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse1 for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.”

 

CLICK HERE TO ACCESS THE COMPLETE PRESS RELEASE

 

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. 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. 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. 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. 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. 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 rather than intramuscular use, is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY reduced the risk of relapse by up to 80%. UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release in the first subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.

 

About MedinCell

MedinCell is an innovative pharmaceutical company with a portfolio of long-acting injectable products, from development to market, in various therapeutic areas. MedinCell proprietary technology BEPO® (licensed to Teva under the name SteadyTeq) makes it possible to control the delivery of a drug at a therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities. www.medincell.com

 

1 UZEDY™ (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.

2 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 disease and treatment, 14, 205–223.

3 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.

4 Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The American journal of psychiatry, 170(6), 609–615.

5 Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia: overview and treatment options. P & T: a peer-reviewed journal for formulary management, 39(9), 638–645..

6 Kane JM, Correll CU. Optimizing treatment choices to improve adherence and outcomes in schizophrenia. J Clin Psychiatry. 2019;80(5):IN18031AH1C. doi:10.4088/JCP.IN18031AH1C.

Contacts

IR Contacts

Ran Meir, +1 (267) 468-4475

Yael Ashman, +972 (3) 914 8262

Sanjeev Sharma, +1 (973) 658 2700

PR Contacts

Kelley Dougherty, 1 (973) 832-2810

Eden Klein, +972 (3) 906 2645

MedinCell France

David Heuzé (Head of Communication), +33 (0) 6 83 25 21 86

david.heuze@medincell.com

Louis-Victor Delouvrier (NewCap – IR), +33 (0) 1 44 71 98 53

medincell@newcap.eu

Nicolas Merigeau (NewCap – Media Relations), +33 (0) 1 44 71 94 98

medincell@newcap.eu