Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

• The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity

• TEV-‘749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being collected as part of the long-term follow-up SOLARIS study

• TEV-‘749 is being developed by Teva as a once-monthly subcutaneous long-acting injection of olanzapine with the use of SteadyTeq™ technology, a copolymer technology proprietary to Medincell

PARSIPPANY, N.J. & TEL AVIV & PARIS, May 08, 2024--(BUSINESS WIRE)--ACCESS HERE THE COMPLETE PRESS RELEASE

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), today announced results from the efficacy portion of the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia compared to placebo. Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo. TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine, the most prescribed 2^nd generation antipsychotic for schizophrenia in the U.S.¹

TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points versus placebo for the high, medium, and low dose groups, respectively. These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of <0.001 for each comparison. Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity. No cases of PDSS have been reported to date, after administration of approximately 80% of the target injection number.

An estimated 3.5 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive, and severely debilitating mental disorder that affects how one thinks, feels and behaves. Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS). PDSS is characterized by the sudden and unexpected onset of delirium or sedation within the first several hours of receiving treatment and has been associated with the intramuscular injection of long-acting olanzapine.

"These encouraging results from the efficacy portion of our Phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "Schizophrenia can be a devastating disease for both the people struggling with it as well their families. Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve. This also has the potential to reduce the burden for not only themselves, but their caregivers and loved ones as well."

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¹ NPA TRx - MAT Jan 2024; schizophrenia factors sourced from 2022 Analytics Link (IQVIA)

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