After a comprehensive review of its strategic priorities, gene therapy specialist bluebird bio has announced that it is initiating a comprehensive restructuring intended to deliver up to $160m in cost savings over the next two years.
The company intends to increase its focus on near-term catalysts – including anticipated FDA approvals for beta-thalassemia and cerebral adrenoleukodystrophy gene therapies. It is also concentrating on the potential submission of a biologics license application (BLA) for the lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease, planned for the first quarter of 2023.
bluebird bio expects to maintain targeted research efforts focused on vivo lentiviral vector (LVV) gene therapy and will, therefore, deprioritise direct investments in reduced toxicity conditioning and cryopreserved apheresis.
This significant shift is expected to reduce the company’s outgoings in 2022 to less than $340m, with a 35-40% reduction in operating costs anticipated by the end of 2022, which is expected to be reflected in bluebird’s operating budget for 2023. As part of the changes, bluebird bio also plans to reduce its workforce by approximately 30%.
“Over more than a decade, Bluebird has made remarkable advances across research, development and manufacturing of gene therapies, and has set the standard for scientific understanding in this rapidly expanding field,” said Andrew Obenshain, chief executive officer, bluebird bio.
He added: “Today, we are taking decisive action to extend our cash runway and put Bluebird in a stronger position to execute on our strategic priorities and ultimately bring potentially curative gene therapies to patients and their families. The decision to reduce our workforce in support of a more focused set of priorities was not taken lightly.”
Considerable cost savings generated through the restructuring project are also intended to bring bluebird bio through a series of significant milestones.
Indeed, if approved, betibeglogene autotemcel (beti-cel) for beta-thalassemia and elivaldogene autotemcel (eli-cel, Lenti-D) for cerebral adrenoleukodystrophy will be the first ex-vivo LVV gene therapies available in the US.
With this considered, the FDA has set PDUFA goal dates of August 2022 for beti-cel and September 2022 for eli-cel. The therapies are expected to be reviewed in consecutive FDA advisory committee meetings tentatively scheduled for June 2022.
