Commercial manufacture of Bluebird’s gene therapy begins, launched in Germany

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Panama7)
(Image: Getty/Panama7)

Related tags bluebird bio apceth Biopharma Zyntelgo Gene therapy

Apceth announces that it has started the commercial manufacture of Zyntelgo, after health insurance companies in Germany agree to pricing structure.

Bluebird bio received marketing approval for Zyntelgo (autologous CD34+ cells encoding βA-T87Q​-globin gene) for the European market in June​ of last year, and has had its first commercial breakthrough by gaining access to the German market.

Due to the nature of bluebird’s gene therapy treatment for patients 12 years and older with transfusion-dependent β-thalassemia (TDT), the biotech has had to create qualified treatment centers that are able to administer Zyntelgo. The first center able to provide the treatment will be University Hospital of Heidelberg.

Another factor that complicates speedily providing access to the treatment is the cost of the treatment, at €1.6m ($1.78m) per patient. In order to mitigate the high cost of the treatment, bluebird has proposed a model where insurers pay five payments of equal installments – with the first made at the time of infusion.

In line with other companies charging substantial amounts for advanced therapeutics, through pay-for-performance deals, bluebird has adopted a model where full payment is only required should the treatment be effective. As a result, after initial infusion, the further four payments are only made should the patient no longer require blood transfusions.

With patients now having access to the treatment in Germany, apceth Biopharma, which was previously revealed to be responsible for production​, stated that it had begun commercial manufacture.

The contract development and manufacturing organization (CDMO) is also responsible for the production of bluebird’s product candidate of Lenti-D for cerebral adrenoleukodystrophy. Apceth produces the treatments from its facilities in Munich, Germany.

Bluebird is currently going through the regulatory process in the US, where it has a rolling biologics license application (BLA) submitted and expects completion of the process in the first half of 2020.

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