Idec Zevalin EU delay

European launch of Idec's Zevalin (ibritumomab) is delayed until the second half of 2003 due to "technical compliance issues" at fill/finish manufacturer DSM Catalytica's Greenville, N.C. facility. Launch will follow EU-mandated facility upgrade at Greenville; facility "modification" will not affect U.S. distribution of the non-Hodgkin's lymphoma therapy, Idec said. Schering AG, which distributes Zevalin outside the U.S., had expected a second half 2002 EU launch. U.S. approval of Zevalin was also delayed by GMP problems at Catalytica; FDA approved Zevalin Feb. 19 (1"The Pink Sheet" Feb. 25, p. 18)...

European launch of Idec's Zevalin (ibritumomab) is delayed until the second half of 2003 due to "technical compliance issues" at fill/finish manufacturer DSM Catalytica's Greenville, N.C. facility. Launch will follow EU-mandated facility upgrade at Greenville; facility "modification" will not affect U.S. distribution of the non-Hodgkin's lymphoma therapy, Idec said. Schering AG, which distributes Zevalin outside the U.S., had expected a second half 2002 EU launch. U.S. approval of Zevalin was also delayed by GMP problems at Catalytica; FDA approved Zevalin Feb. 19 (¹ (Also see "Idec Zevalin NHL Indication Split By Accelerated/Standard Approval" - Pink Sheet, 25 Feb, 2002.), p. 18)....