Teva falls after FDA declines to approve drug with partner Alvotech

Alvotech SA

14/04/2023 13:09

** U.S.-listed shares of Israel-based Teva Pharmaceutical
Industries Ltd  TEVA.N  fall ~5% premarket to $8.80
    ** U.S. FDA issues complete response letter to partner
Alvotech  ALVO.O  for its anti-inflammatory drug candidate,
AVT02
    ** AVT02 is a biosimilar drug candidate to AbbVie Inc's
rheumatoid arthritis drug Humira
    ** FDA declined approval based on deficiencies associated
with Alvotech’s manufacturing facility in Reykjavik that were
conveyed to ALVO after conclusion of reinspection on March 17
    ** Additional review of details after FDA’s recent
reinspection & CRL are being assessed to determine next steps -
TEVA
    ** In a separate statement, Alvotech said FDA noted no other
deficiencies in the application 
    ** Alvotech said it has provided the FDA comprehensive
responses to the inspection observations and is awaiting
communication from the agency
    ** Up to last close, U.S.-listed shares of Teva had risen
1.54% this year

 (Reporting by Ashwini Raj in Bengaluru)
 ((Ashwini.Raj@thomsonreuters.com))