Brief: Rpt-Poxel SA - Times 2 Was Third And Final Pivotal Registration Trial From Phase 3 Times Program

Poxel SA

20/12/2019 06:19

Poxel SA  POXEL.PA :
    * POXEL SA - IMEGLIMIN JAPANESE NEW DRUG APPLICATION
TARGETED FOR
2020 (NOT 20202) WITH A PRODUCT LAUNCH ANTICIPATED IN 2021 (NOT
20212)
    * POXEL AND SUMITOMO DAINIPPON PHARMA ANNOUNCE POSITIVE
TOPLINE
PHASE 3 RESULTS FROM TIMES 2 TRIAL OF IMEGLIMIN FOR THE
TREATMENT OF TYPE 2 DIABETES IN JAPAN AND SUCCESSFUL COMPLETION
OF THE PIVOTAL TIMES CLINICAL DEVELOPMENT PROGRAM
    * POXEL SA - TIMES 2 WAS THIRD AND FINAL PIVOTAL
REGISTRATION
TRIAL FROM PHASE 3 TIMES PROGRAM
    * POXEL SA IMEGLIMIN MET ITS KEY EFFICACY ENDPOINT OF HBA1C
REDUCTION
    * POXEL SA - TIMES 2 WAS THIRD AND FINAL PIVOTAL
REGISTRATION
TRIAL FROM PHASE 3 TIMES PROGRAM
    * POXEL SA - IN PARTICULAR, IMEGLIMIN WAS OBSERVED TO
DEMONSTRATE
ROBUST EFFICACY BENEFITS IN COMBINATION WITH DPP-4 INHIBITORS,
MARKET LEADER IN JAPAN AND PRESCRIBED TO APPROXIMATELY 80% OF
TREATED TYPE 2 DIABETES PATIENTS
    * POXEL SA - IMEGLIMIN WAS OBSERVED TO EXHIBIT FAVORABLE
SAFETY
AND TOLERABILITY PROFILE ACROSS ALL TREATMENT ARMS, CONSISTENT
WITH PRIOR TRIALS

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Further company coverage:  POXEL.PA