Nov. 21, 2013
Amgen Statement on Analyst Comments Concerning Kyprolis Trial Data
THOUSAND OAKS, Calif. (Nov. 21, 2013) – The biotech analyst at Bank of America Merrill Lynch issued a misleading note this morning following a dinner meeting with Celgene management. In our follow up with Celgene, they acknowledged citing anecdotal reports from high volume multiple myeloma centers of cardiovascular (CV) events with Kyprolis, but also clarified that they made no representation of the event rates being any different than what is already included in the Kyprolis label. The Phase 3 Kyprolis trials are monitored and safety data are reviewed regularly by independent Data Monitoring Committees (DMCs). To date, the DMCs have not reported any specific safety concerns and have recommended continuing the Phase 3 studies. The Bank of America Merrill Lynch note incorrectly characterizes confidential information on event rates during the course of the ASPIRE study, which are not shared with Celgene as part of the supply agreement. Our post-marketing reporting and on-going clinical trial data have not revealed any new safety concerns. We remain enthusiastic about our ongoing comprehensive Phase 3 global development program for Kyprolis across all lines of therapy to address unmet medical needs of multiple myeloma patients.