Bluebird bio have announced plans to reduce and reshape its European workforce after a series of setbacks, including unsuccessful reimbursement negotiations for Zynteglo with German health authorities.
The company has decided to withdraw Zynteglo from the German market and will be conducting a targeted reshaping of its workforce in order to enable the company to advance its late-stage gene therapy programs. According to bluebird, the reimbursement negotiations in Germany did not result in a price for Zynteglo that reflects the value of this one-time gene therapy with potential life-long benefit for people living with TDT. Its reduction and reallocation of resources will allow the company to focus on priority European markets and streamline global operations going forward says bluebird.
Bluebird says that the case of MDS reported in February in a patient from Group C of the Phase 1/2 HGB-206 study of LentiGlobin gene therapy for SCD has been further assessed following the review of results from additional tests. The treating investigator has concluded this is not a case of MDS and has revised the diagnosis to transfusion-dependent anemia. bluebird bio has reported this update to regulatory agencies and study investigators and will continue to work to determine the potential cause of this patient’s anemia.
Last month, the company reported that it is very unlikely the suspected unexpected serious adverse reaction of acute myeloid leukemia reported in the HGB-206 study of LentiGlobin for SCD was related to the BB305 lentiviral vector. This assessment, along with the re-classification of the originally reported MDS case to transfusion-dependent anemia are important steps in bluebird bio’s path to seeking removal of the clinical hold on studies HGB-206 and HGB-210 of LentiGlobin for SCD.
Bluebird bio continues with negotiations with other European countries.
Read the bluebird bio statement