Bluebird Bio launches Zynteglo in Europe blocked and starts layoffs

CompileKe Ke

Bluebird said on Tuesday (April 20) that after solving the setbacks related to the manufacturing industry and overcoming the delays caused by the COVID-19 pandemic, Zynteglo failed to reach an agreement with the German authorities, the first listed country.

Due to the frustration of Zynteglo's listing on the first European market, Bluebird Bio is currently laying off employees and plans to "reduce and reshape" its workforce in parts of Germany.

Germany's setbacks are not the only driving factor for layoffs.

Bluebird Biologics has targeted Zynteglo's first indication for the treatment of beta-thalassemia for commercial promotion in Germany, and many other companies' drugs follow this strategy when they are launched in Europe.

Now, the company says that the compensation price proposed by the German health authorities does not reflect the potential lifelong benefits of Zynteglo as a one-time treatment for a serious genetic disease.

Bluebird said that although the company continues to have "fruitful negotiations" with other European countries, it has decided to lay off employees to "focus on European priority markets.

Zynteglo (betibeglogene autotemcel, beti-cel) is a one-time gene therapy that adds a functional copy of a modified form of β-globin gene (βA-T87Q-globin gene) to the patient’s own hematopoietic (blood) stem cells (HSCs) in.

The European Commission approved the conditional marketing authorization (CMA) of beti-cel, the trade name is Zynteglo™ gene therapy, which is suitable for transfusion-dependent β-thalassemia (TDT) patients who are 12 years old and older without β0/β0 genotype, hematopoietic Stem cell (HSC) transplantation is suitable, but there is no relevant HSC donor that matches human leukocyte antigen (HLA).

Zynteglo won EU approval in early 2019.

Just as the drug's marketing finally kicked off earlier this year, Bluebird Bio suffered another setback in February.

Bluebird Bio launched an investigation last month and received positive news.

On Tuesday, Bluebird Bio pointed out that the diagnosis of MDS cases has been revised to transfusion-dependent anemia.

These mysteries seem to have been solved, and Bluebird now believes that it has enough information to persuade regulatory agencies to lift the clinical hold on sickle cell disease research, including phase 3 trials.

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