PETAH TIKVA (dpa-AFX) - Teva Pharmaceuticals International GmbH, a unit of Teva Pharmaceutical Industries (TEVA), and Medincell announced that the European Medicines Agency has accepted the Marketing Authorization Application for olanzapine long-acting injectable, or TEV-'749, for the treatment of schizophrenia in adults. TEV-'749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled, steady, prolonged release of olanzapine.
The company said the submission is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. TEV-'749 is not approved by any regulatory authority worldwide.
At last close, shares of Medincell were trading at 26.62 euros, down 1.19%.
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