Teva Pharmaceuticals Industries Ltd. and MedinCell announced positive results for study TV46000-CNS-30072, a Phase 3 clinical trial designed to evaluate the efficacy of TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) as a treatment for patients with schizophrenia. Trial enrollment was open to patients 13-65 years of age. In the RISE study, patients treated with the investigational subcutaneous risperidone injection either monthly (q1M) (n=183) or once every two months (q2M) (n=179) experienced a statistically significant delay in time to relapse versus placebo (n=181), the study's primary endpoint, with p<0.0001 for each comparison.

The investigational subcutaneous risperidone injection q1M and q2M demonstrated a reduction of 80.0% and 62.5% in the risk to relapse compared to placebo, respectively. No new safety signals have been identified that are inconsistent with the known safety profile of other risperidone formulations. The second of Teva's Phase 3 studies (TV46000-CNS-30078 – the SHINE study) evaluating the long-term safety and tolerability of the investigational subcutaneous risperidone injection across 331 patients is ongoing.

Interim results align with the safety findings of the RISE study. Teva will continue to lead the clinical development and regulatory process and be responsible for commercialization of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales and future commercial milestones.