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bluebird bio posts modest Q4 revenue growth as it continues investigation into troubled LentiGlobin

Company announced clinical hold on gene therapy earlier this month after suspected serious adverse reaction

bluebird bio has posted a modest increase in its Q4 revenues and has also provided an update about its clinical hold on its sickle cell disease gene therapy LentiGlobin.

For the three months ended 31 December 2020, bluebird reported total revenues of $10.7m, a modest increase on the $10m reported in the same period last year.

For the full year, total revenue came in at $250.7m compared to $44.7m in 2019, with this increase attributed to the company’s amended collaboration with Bristol Myers Squibb (BMS) and monetisation for ex-US milestones and royalties from CAR T cell therapies ide-cel and bb21217.

However, the company also reported an increase in selling, general and administrative (SG&A) expenses, which increased to $286.9m in 2020 compared to $271.4m in 2019.

That increase, says bluebird, is due to an increased headcount and costs associated with the company’s ongoing operations and growth of its pipeline.

bluebird also reported a decrease in net losses for 2020, with the total net loss for the full year 2020 reported as $618.7m compared to $789.6m in 2019.

Last week, bluebird announced that the US Food and Drug Administration (FDA) had placed a clinical hold on phase 1/2 and phase 3 studies of its gene therapy LentiGlobin in sickle cell disease.

The suspension comes after a reported suspected unexpected serious adverse reaction (SUSAR) of acute myeloid leukaemia and a separate SUSAR of myelodysplastic syndrome in the company’s HGB-206 study.

In addition to the clinical holds, bluebird has also temporarily paused marketing of the gene therapy in Europe, where it is currently marketed as Zynteglo for the treatment of beta thalassaemia.

In its full year 2020 results and operational highlights, bluebird added that the European Medicines Agency (EMA) has paused the renewal procedure for Zynteglo’s conditional marketing authorisation.

This, according to bluebird, is so the EMA’s pharmacovigilance risk assessment committee can review the risk-benefit assessment for the gene therapy.

Zynteglo was initially approved in the EU in 2019, with the conditional marketing authorisation covering use of the gene therapy in patients 12 years and older with transfusion-dependent beta-thalassaemia (TDT).

Specifically, it was authorised for the moderately severe TDT form of the disease, and not for the more acute β0/β0 genotype, where haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.

“We remain focused on the upcoming prescription drug user fee act (PDUFA) action due date for ide-cel for multiple myeloma next month, the potential EU approval of eli-cel for CALD mid-year and the planned US filings for beta-thalassemia and CALD later in the year,” said Nick Leschly, chief executive officer of bluebird.

Article by
Lucy Parsons

24th February 2021

From: Sales



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