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Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) is a leading Israeli multinational pharmaceutical company headquartered in Tel Aviv, Israel. As the world's largest generic drug manufacturer, Teva plays a pivotal role in the global healthcare industry. The company derives approximately 50% of its sales from North America, contributing significantly to the total number of generic prescriptions in the United States.
Teva's extensive portfolio includes not only generic drugs but also active pharmaceutical ingredients (APIs) and proprietary pharmaceuticals. The company's operations are categorized into three main therapeutic areas:
- Central Nervous System (CNS): Featuring notable products such as Copaxone, Ajovy, and Austedo, Teva addresses critical CNS disorders with innovative treatments.
- Respiratory: Products like Qvar and ProAir contribute to Teva's robust respiratory medicine lineup, catering to patients with various respiratory conditions.
- Oncology: Teva's oncology portfolio includes groundbreaking medicines such as Truxima, Herzuma, and Bendeka/Treanda, providing essential treatments for cancer patients.
In addition to its pharmaceutical products, Teva is a major player in active pharmaceutical ingredients, offering contract manufacturing services and owning Anda, a U.S.-based distributor of generic and specialty drugs.
Teva's global presence extends beyond North America, with significant operations in Europe, Japan, Russia, and its home country, Israel. The company's strategic partnerships and innovations keep it at the forefront of the pharmaceutical industry. Recent developments include advancements in biosimilars and innovative treatments.
Financially, Teva continues to maintain a strong position, focusing on growth and resilience amidst market challenges. The company is committed to improving patient health worldwide by providing high-quality, affordable medicines.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) announced positive results from a new analysis of the European cohort in the RIM-TD open-label extension study. The study showed that deutetrabenazine treatment for Tardive Dyskinesia (TD) patients led to long-term improvement of symptoms over three years. TD is an involuntary movement disorder affecting 15%-25% of patients taking antipsychotic medications.
Key findings presented at the European College of Neuropsychopharmacology Congress include:
- 65% of patients achieved treatment success on the Clinical Global Impression of Change (CGIC)
- 56% of patients achieved treatment success on the Patient Global Impression of Change (PGIC)
- Deutetrabenazine was generally well-tolerated
The study highlights the potential of deutetrabenazine as an effective treatment option for TD, addressing a high unmet medical need in Europe where treatment options are approved.
Teva Pharmaceuticals announced positive results from the Phase 3 SOLARIS trial evaluating TEV-'749, a once-monthly subcutaneous long-acting injectable olanzapine for adult schizophrenia patients. The study met its primary endpoint, showing significant improvements in PANSS total scores across all dosing groups compared to placebo. Key secondary endpoints, including CGI-S and PSP scale scores, also improved significantly.
Importantly, no incidence of post-injection delirium/sedation syndrome (PDSS) was reported in participants taking TEV-'749 to date. This addresses a major barrier in the utilization of intramuscular olanzapine LAIs. The overall safety profile was consistent with other oral acting olanzapine options.
TEV-'749 utilizes SteadyTeq™, Medincell's proprietary copolymer technology for controlled steady release of olanzapine. Long-term safety data from the open-label study (Period 2) is expected in the first half of 2025.
Teva Pharmaceuticals presented new data at the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress, providing insights on switching adult schizophrenia patients to UZEDY® (risperidone extended-release injectable suspension) from Perseris® (RBP-7000). The study found that switching to UZEDY 4 weeks after the last dose of once-monthly RBP-7000 resulted in comparable pharmacokinetic profiles.
Additionally, new findings from the ADVANCE survey highlighted key reasons for patients accepting long-acting injectable (LAI) treatments, including symptom improvement, healthcare provider recommendations, and ease of use. The survey also revealed that most healthcare providers recommend LAIs primarily due to nonadherence to oral medication.
These data aim to support clinicians in making informed decisions about treatment options for schizophrenia patients, considering that up to 80% experience multiple relapses in the first five years.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced that its President and CEO, Richard Francis, will be presenting at the Bank of America 2024 Global Healthcare Conference. The presentation is scheduled for Thursday, September 19, 2024, at 8:15 AM British summer time (3:15 AM Eastern Time).
Interested parties can access a live webcast of the presentation through Teva's Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. For those unable to attend the live event, an archived version of the webcast will be made available within 24 hours after the live discussion concludes.
Teva Pharmaceuticals has provided an update on the pivotal Phase 3 clinical trial of its investigational Olanzapine Long-Acting Injectable (LAI). The company announced that approximately 99% of the targeted injections for submission have been completed, with no Post-Injection Delirium/Sedation Syndrome (PDSS) observed. Teva confirmed that full phase 3 safety results are expected in H2 2024, following the positive efficacy results announced in May 2024.
Olanzapine LAI is being developed as a once-monthly subcutaneous injection for atypical antipsychotic treatment. It has the potential to be the first long-acting Olanzapine with a favorable safety profile, as other LAIs of Olanzapine have FDA black box warnings for PDSS. Teva's partner, Medincell, may receive up to $117 million in milestones and royalties on net sales.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced that its President and CEO, Richard Francis, will be presenting at the Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, 2024. The presentation is scheduled to begin at 11:30 A.M. Eastern Time.
Interested parties can access a live webcast of the presentation through Teva's Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. For those unable to attend the live event, an archived version of the webcast will be made available within 24 hours after the conclusion of the live discussion.
MedinCell's partner Teva has provided an update on the pivotal Phase 3 clinical trial of their investigational Olanzapine Long-Acting Injectable (LAI) and the commercial progress of UZEDY®. Key highlights include:
1. No Post-Injection Delirium/Sedation Syndrome (PDSS) observed after completion of approximately 95% of targeted injections for submission in the Olanzapine LAI Phase 3 trial.
2. Full Phase 3 safety results for Olanzapine LAI are on track for H2 2024, with positive efficacy results already announced in May 2024.
3. Teva is reaffirming UZEDY® revenue guidance for 2024 at approximately $80 million.
4. Teva is exploring an additional indication for UZEDY® for the treatment of Bipolar I Disorder in adults.
Teva reported a strong Q2 2024 with revenues of $4.2 billion, a 7% increase in USD and 11% in local currency compared to Q2 2023.
Generics saw growth across all regions with U.S. revenues up 16%, European up 8%, and International Markets up 22%. AUSTEDO U.S. revenues increased by 32% to $407 million, prompting a raised 2024 revenue outlook to ~$1.6 billion. AJOVY global revenues rose 12% to $115 million.
Teva accelerated development for duvakitug (Anti-TL1A) with top-line results expected in Q4 2024. Positive Phase 3 results were announced for olanzapine LAI. SIMLANDI and SELARSDI launches are planned for 2024 and 2025, respectively.
Financial highlights include a GAAP loss per share of $0.75 and a non-GAAP EPS of $0.61. The company raised its 2024 outlook, expecting revenues between $16.0 - $16.4 billion and adjusted EBITDA of $4.6 - $5.0 billion.
Net losses were $846 million, with a significant tax expense affecting results. Free cash flow decreased to $324 million from $632 million in Q2 2023, and total debt was reduced to $18.64 billion.
Teva Pharmaceuticals and Sanofi have announced an accelerated timeline for their anti-TL1A Phase 2b program in inflammatory bowel disease (IBD) patients. The RELIEVE UCCD trial, investigating duvakitug for moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), has completed patient enrollment earlier than expected due to rapid recruitment. As a result, topline results for both UC and CD are now anticipated in Q4 2024, with detailed results to be presented in 2025. This acceleration replaces the previously planned interim analysis for the second half of 2024. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug, potentially a best-in-class IBD treatment.
Teva Pharmaceutical Industries (NYSE and TASE: TEVA) announced positive topline results from its Phase 3 SPACE study evaluating AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescents aged 6-17 years. The trial met its primary endpoint, demonstrating statistically significant superior efficacy over placebo in reducing Monthly Migraine Days during 12 weeks of treatment. Safety data was consistent with adult populations, with no new safety signals observed.
This marks the first Phase 3 evidence of safety and efficacy for an anti-CGRP monoclonal antibody in pediatric migraine prevention. The results are particularly significant given the lack of approved preventive treatments for children and adolescents. Full data will be presented at a medical meeting later in 2024. Teva continues to study AJOVY in pediatric patients with chronic migraine.
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