Wednesday, Teva Pharmaceutical Industries Ltd (NYSE:TEVA) and Medincell announced results from the efficacy portion of the Phase 3 SOLARIS trial of TEV-';749 in adult patients with schizophrenia compared to placebo.
The results demonstrated that TEV-';749 met its primary endpoint as measured by a change in the PANSS total score from baseline after eight weeks compared to placebo. PANSS measures the symptom severity of schizophrenia.
TEV-';749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled, steady release of olanzapine, the most prescribed 2nd generation antipsychotic for schizophrenia in the U.S.
TEV-';749 met its primary endpoint across all three dosing groups, with a 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.
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 after the administration of approximately 80% of the target injection number.
The long-term safety of TEV-';749 and the incidence of post-injection delirium/sedation syndrome (PDSS) are also being evaluated in the SOLARIS open-label study (period 2), with safety data topline readout expected in the second half of 2024.
Wednesday, Teva Pharmaceutical also reported the first quarter adjusted EPS of $0.48, up from $0.40 a year ago, missing the consensus of $0.51.
The company reported sales of $3.82 billion, beating the consensus of $3.73 billion.
Revenues increased 4% in U.S. dollars or 5% in local currency terms, mainly due to higher revenues from generic products in all segments, from Austedo and Ajovy in Europe and International Markets segments, partially offset by lower revenues from Copaxone.
Generic products revenues were $808 million, up 8%, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid).
In the first quarter of 2024, total prescriptions were approximately 314 million, representing 8.2% of U.S. generic prescriptions.
Teva also reaffirmed its 2024 business outlook, with revenues of $15.7 billion – $16.3 billion (consensus $15.862 billion) and adjusted EPS of $2.20 – $2.50 (consensus $2.41).
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Price Action: TEVA shares are up 15.3% at $16.09 at last check Wednesday.
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