Brief: Orphazyme Announces Withdrawal Of European Marketing Authorisation Application For Arimoclomol

Strategic Partners A/S

22/03/2022 10:58

March 22 (Reuters) - Orphazyme A/S  ORPHA.CO :
    * REG-ORPHAZYME ANNOUNCES WITHDRAWAL OF EUROPEAN MARKETING
AUTHORISATION APPLICATION FOR ARIMOCLOMOL FOR THE TREATMENT OF
NIEMANN-PICK DISEASE TYPE C
    * REG-ORPHAZYME ANNOUNCES WITHDRAWAL OF EUROPEAN MARKETING
AUTHORISATION APPLICATION FOR ARIMOCLOMOL FOR THE TREATMENT OF
NIEMANN-PICK DISEASE TYPE C
    * INTENDS TO REQUEST TYPE C MEETING WITH U.S. FOOD AND DRUG
ADMINISTRATION TO DISCUSS POTENTIAL PATHWAY FOR RESUBMISSION OF
NEW DRUG APPLICATION FOR ARIMOCLOMOL FOR NIEMANN-PICK DISEASE
TYPE C
    * DECIDED TO WITHDRAW ITS EUROPEAN MARKETING AUTHORISATION
APPLICATION (MAA) FOR ARIMOCLOMOL FOR TREATMENT OF NIEMANN-PICK
DISEASE TYPE C (NPC) AHEAD OF A FINAL VOTE AND OPINION BY CHMP
ON MAA SCHEDULED FOR LATER THIS MONTH.
    * IS CURRENTLY UNDER AN IN-COURT RESTRUCTURING AND HAS
REDUCED ITS
WORKFORCE BY APPROXIMATELY 50% TO REDUCE COSTS AS IT SEEKS TO
EXPLORE WHETHER A BASIS CAN BE ESTABLISHED FOR ALL OR PART OF
COMPANY'S OPERATIONS TO CONTINUE, INCLUDING A SALE OF ALL OR
PARTS OF COMPANY'S ASSETS
    * AT THIS STAGE IT IS UNCERTAIN WHETHER A SOLUTION CAN BE
FOUND,
AND FURTHER UPDATE WILL BE PROVIDED AT APPROPRIATE TIME.
    * CONTINUES TO WORK TOWARDS RESUBMISSION OF COMPANY'S NEW
DRUG
APPLICATION FOR ARIMOCLOMOL TO U.S. FOOD AND DRUG ADMINISTRATION
(FDA) AND PLANS TO REQUEST A TYPE C MEETING IN Q2 2022.

Source text for Eikon:  ID:nGNE3Y4r2h 
Further company coverage:  ORPHA.CO 

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