TEVA News & Events

Teva Pharmaceuticals, a U.S. affiliate of Teva (TEVA) and funds managed by Blackstone Life Sciences (BX) announced a $400M strategic funding agreement spread across four years to support the continued clinical development of duvakitug. Additionally, under the terms of the agreement, Blackstone Life Sciences will be eligible for regulatory and commercial milestones as well as royalties on duvakitug worldwide sales. Duvakitug is a human monoclonal antibody targeting TL1A, a promising target with the potential for broad therapeutic application across multiple indications. Under a separate and independent agreement announced in 2023, Teva is co-developing and, subject to regulatory approval, will be co-commercializing this asset with Sanofi (SNY). Duvakitug is currently in phase 3 clinical studies for the treatment of ulcerative colitis and Crohn's disease. Both companies recently announced phase 2b duvakitug maintenance data demonstrating clinically meaningful durable efficacy in ulcerative colitis and Crohn's disease. Under the agreement, Blackstone Life Sciences will provide Teva $400M to fund ongoing and future development costs for duvakitug, spread over four years. As part of the funding arrangement and subject to the approval of duvakitug by the FDA, Teva will pay Blackstone Life Sciences a milestone payment. Blackstone Life Sciences will also be eligible to receive commercial milestones and low single-digit royalties on duvakitug worldwide sales, subject to customary terms and conditions.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell announced that the U.S. Food and Drug Administration has accepted its New Drug Applicationfor olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. "TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia. Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy, which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring," the company stated.