Teva Pharm - TEVA STOCK NEWS

Teva Pharmaceutical Industries announced that the U.S. FDA has accepted and the EU EMA has validated applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab). The applications seek approval for all indications of Prolia, including osteoporosis in postmenopausal women. Decisions from both agencies are expected in the second half of 2025.

TVB-009P is Teva's first internally developed biosimilar submitted to the U.S. FDA. The submissions are supported by comprehensive data, including results from a Phase 3 trial and a pharmacokinetics study. Teva, with over 120 years of experience, is a leader in the biosimilar market with 7 approved biosimilars and 16 in the pipeline.

The company aims to expand access to affordable treatment options, particularly for conditions like osteoporosis, which affects about 25% of older women in the U.S. and EU.

Teva Pharmaceuticals and mAbxience have expanded their strategic partnership to include an additional oncology biosimilar candidate. This new global licensing agreement focuses on the development of an anti PD-1 oncology biosimilar, marking their second collaboration since April 2024. The partnership aligns with Teva's Pivot to Growth strategy and enhances its biosimilar portfolio.

Under the agreement, mAbxience will lead the development and production of the biosimilar using its facilities in Spain and Argentina, while Teva will manage regulatory approvals and commercialization in designated markets, including Europe and the United States. This collaboration aims to provide cost-effective, high-quality biosimilar treatments in oncology care, addressing unmet needs and improving global healthcare accessibility.

Teva Pharmaceuticals has launched the first and only generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension) in the United States. This medication is used to treat acromegaly and severe diarrhea associated with carcinoid syndrome. The launch demonstrates Teva's expertise in complex generic formulations and supports its goal of maintaining a strong position in the generics market.

Octreotide acetate for injectable suspension is indicated for long-term maintenance therapy in acromegalic patients and for the long-term treatment of severe diarrhea and flushing episodes related to metastatic carcinoid tumors and VIP-secreting tumors. The annual sales of Sandostatin® LAR Depot were $826 million as of July 2024, according to IQVIA data.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has announced its plans to release its third quarter 2024 financial results on Wednesday, November 6, 2024, at 7:00 a.m. ET. Following this release, the company will host a conference call and live webcast at 8:00 a.m. ET on the same day.

Interested participants are required to register in advance to obtain a local or toll-free phone number and personal pin for the call. A live webcast will be available on Teva's investor relations website. After the call's conclusion, a replay of the webcast will be accessible within 24 hours on the company's website.

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.