Orphazyme down on withdrawal of European marketing application for lead drug

Strategic Partners A/S

22/03/2022 12:31

** U.S.-listed shares in Denmark-based biotech co Orphazyme
 ORPH.O  fall 8.3% to $0.77 premarket
    ** Co withdraws its European Marketing Authorisation
Application (MAA) for arimoclomol, its experimental drug for
Niemann-Pick disease Type C  urn:newsml:reuters.com:*:nGNE3Y4r2h
    ** Neimann-Pick disease Type C is a rare genetic disorder
that causes abnormal accumulation of cholesterol and other fatty
substances in the body
    ** Decision to withdraw application was made following the
receipt of negative trend vote by experts panel of the European
regulatory body that was announced on Feb. 23 - ORPH 
    ** U.S. FDA in June declined to approve arimoclomol over the
need for additional evidence needed to show the drug's
effectiveness
    ** Orphazyme intends to request a meeting with the U.S. FDA
in Q2 to discuss potential pathway for resubmission of its
marketing application for arimoclomol

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))