Jazz Pharma and Gentium debut Defitelio in Europe

Ireland-headquartered Jazz Pharmaceuticals (Nasdaq: JAZZ) and its Italian subsidiary Gentium have initiated the European commercial roll-out of Defitelio (defibrotide), the first licensed product for the treatment of severe hepatic veno-occlusive disease (severe VOD or sVOD) in patients over one month of age undergoing hematopoietic stem cell transplantation (HSCT) therapy.

The companies have launched Defitelio in Germany and Austria and expect to continue the launch in 27 additional European countries on a rolling basis during 2014 and 2015. The drug was developed by Gentium and was the main attraction for Jazz’s $1 billion acquisition of the Italian firm last year (The Pharma Letter December 20, 2013). Defitelio was approved in Europe last year and has orphan status in Europe and the USA (TPL October 11, 2013).

Severe VOD, one of the most serious early complications in HSCT therapy, is associated with multi-organ failure and is fatal in over 80% of patients. HSCTs are performed with curative intent in patients with hematological malignancies, selected solid tumors and some non-malignant disorders, such as serious hemoglobinopathies.