March 17, 2020 / 11:38 AM / 24 days ago

BRIEF-Mabion To Seek Direct EMA Approval For MabionCD20 Large Commercial Scale

March 17 (Reuters) - Mabion SA:

* SAID ON MONDAY IT HAS DECIDED TO MODIFY ITS REGULATIONS STRATEGY FOR MABIONCD20 DRUG WITH EMA

* THE COMPANY WILL SEEK EMA APPROVAL FOR DRUG DIRECTLY IN LARGE COMMERCIAL SCALE

* PREVIOUS PLANNED STRATEGY WAS TWO-STEP WITH SMALL-SCALE APPROVAL FOLLOWED BY LARGE COMMERCIAL SCALE APPROVAL

* THE COMPANY WILL SUBMIT A NEW APPLICATION TO EMA FOR CONSIDERATION OF TARGET SCALE

* THE COMPANY WILL MAKE SUBMISSION AFTER IT GETS VALIDATION DATA AND BIOSIMILARITY OF PRODUCT MADE DURING FULL SCALE PRODUCTION

* CURRENT ANALYTICAL DATA FOR LARGE SCALE SHOWS REPEATABILITY AND HIGH DEGREE OF BIOSIMILARITY, WHICH SIGNIFICANTLY RAISES PROBABILITY OF WITHDRAWING FROM ADDITIONAL LARGER CLINICAL TRIALS

* THE COMPANY HAS BEGUN THIRD PRODUCTION VALIDATION SERIES OF LARGE SCALE

* MODIFIED STRATEGY IS MOST OPTIMAL PATH IN TERMS OF FINANCES AND TIME WITH REGARD TO REGISTRATION OF PRODUCT COMING FROM LARGE SCALE PROCESS AND COMMERCIALISATION OF THE DRUG IN THE EU

* THE COMPANY INTENDS TO FINALISE THE REGISTRATION OF THE LARGE SCALE PROCESS PRODUCT IN JUNE 2020

* CONSULTATIONS WITH EMA REPRESENTATIVES UNDER SCIENTIFIC ADVICE PROCEDURE REGARDING THE RANGE AND FORMAT OF THE NEW SUBMISSIONS ARE PLANNED FOR APRIL/MAY

* DECISION REGARDING WITHDRAWAL OF APPLICATIONS DOES NOT AFFECT TIMETABLES FOR LARGE SCALE PRODUCTION VALIDATION, BRIDGING STUDIES AND WORKS TOWARDS REGISTERING THE DRUG IN THE UNITED STATES

Source text for Eikon:

Further company coverage: (Gdansk Newsroom)

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