Brief: Santhera Pharmaceuticals: FDA Approved AgamreeFor Treatment Of Duchenne Muscular Dystrophy

Santhera Pharmaceuticals Holding AG

27/10/2023 06:04

Oct 27 (Reuters) - Santhera Pharmaceuticals Holding AG
 SANN.S :
    * FOOD AND DRUG ADMINISTRATION (FDA) APPROVED AGAMREE®
(VAMOROLONE) FOR TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD)
IN CHILDREN AND ADULTS AGED 2 YEARS AND OLDER
    * U.S. LICENSE HOLDER CATALYST PHARMACEUTICALS PLANS FOR
COMMERCIAL LAUNCH IN Q1-2024
    * FDA APPROVAL TRIGGERS USD 36 MILLION PAYMENT OBLIGATION
FROM
CATALYST TO SANTHERA, OF WHICH USD 26 MILLION WILL BE USED TO
COVER SANTHERA'S THIRD-PARTYMILESTONE OBLIGATIONS
    * FOLLOWING RECENT POSITIVE CHMP OPINION ON AGAMREE IN DMD,
APPROVAL IN EUROPEAN UNION BY EUROPEAN COMMISSION (EC) IS
EXPECTED IN LATE 2023
    * AGAMREE WOULD THEN BECOME FIRST DRUG FULLY APPROVED IN
BOTH U.S.
AND EUROPE FOR TREATMENT OF PATIENTS WITH DMD

Source text for Eikon:  ID:nGNE26mZc5 
Further company coverage:  SANN.S 

 (Reporting by Berlin Newsroom)
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