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APEIRON Biologics given green light for market approval

Hans Loibner, Apeiron CEO © Apeiron

The development of dinutuximab beta originally began at the Clinical Cancer Research Institute of St. Anna Children’s Hospital in Vienna and was extended to encompass numerous clinical studies throughout Europe and abroad.

In 2011, Apeiron acquired commercial rights to the project, and then led efforts to win market approval in cooperation with academic groups. More than 1,000 patients have been treated up until now. In September 2016, Apeiron EUSA Pharma acquired an exclusive license to the global commercial rights to dinutuximab beta.

The CHMP recommendation issued on March 24, 2017 will be presented to the European Commission by the EMA. The European Commission will issue a formal decision on the approval of dinutuximab beta within the next two months.

Neuroblastoma is the third most frequent malignant tumor afflicting children. The tumors arise from cells of so-called autonomic nervous system. The apparent cause is that cells do not sufficiently mature in their development phase and then begin to reproduce themselves later in an unrestrained manner. About one out of every 5,000 children suffers from this illness. One third of the tumors already occur in children’s first year.

 

About APEIRON Biologics AG

Apeiron is a private biotech company in Vienna, Austria developing innovative projects in the field of immune-oncology..

For more information: www.apeiron-biologics.com

 

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