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6-K
OBSEVA SA filed this Form 6-K on 03/30/2018
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ABT May Not be Appropriate for All Patients: Exogenous vs endogenous estrogens Add-back draw backs ✓Reduced bleeding control (spotting and/or breakthrough bleeding): > 50% ✓Study and post marketing side effects: breast pain (24%)1, mood, libido, water retention ✓Reduction in anti-fibroid efficacy: approximately 10% ✓Contra-indication (estrogen dependent neoplasia, history/risk of thrombo-embolic disease, liver dysfunction)1: 5 %     OBE2109 100 mg100 mg100 mg200 mg200 mg Daily Dose(n=14)(n=14)(n=15)(n=15)(n=15) Data fromAdd-Back E2/NETA-0.5mg/0.1mg1mg/0.5mg-1mg/0.5mg OBE2109 PK/PD study3Amenorrhea (no bleeding)86%21%53%87%33% Amenorrhea + (spotting only)93%57%93%100%60% Leuprolide Acetate (LA)discontinuation rate (within 6 months) in endometriosispatients2 ✓ LA alone:59.6%1 Activella US FDA label 2 Soliman A.M. et al., J Manag Care Spec Pharm 2016; 22 (5):573-87 ✓ LA + ABT:37.9%—40.2%3 Pohl O. et al., J Clin Endocrinol Metab 2018; 103(2): 497-504