Faron Pharmaceuticals Ltd. and Rentschler Biotechnologie GmbH have announced that they have signed a manufacturing and supply agreement for the Faron product FP-1201 that is also known as Traumakine®.
The active pharmaceutical ingredient of the FP-1201 is recombinant human interferon beta-1a (IFN-beta 1a) that was first produced by Rentschler already in the late 1980’s. According to the agreement Rentschler will become the sole global manufacturer of IFN-beta 1a for Faron and also manufacture Faron’s proprietary bulk drug product.
Traumakine® is formulated so that it is stable at room temperature and readily available for critical care doctors at intensive treatment units. Traumakine® is meant to prevent vascular leakage in patients with acute lung injuries (ALI) and its more severe form ARDS. This prevention is critical to sustain respiratory function in ALI/ARDS patients. Financial details of the agreement were not disclosed.
"Our aim is to build a specialty pharma product for critical care doctors treating ALI/ARDS patients at intensive care units", comments Faron’s CEO Markku Jalkanen.
"We are very satisfied with our collaboration with Rentschler and their experience with manufacturing and formulation of interferon-beta. This agreement allows Faron to move to final clinical development stage of Traumakine®, and to file marketing authorization application to European Medicines Agency (EMA) following the conduction of the pan-European pivotal trial in years 2012-14", continues Jalkanen.
"Rentschler has the longest history of IFN-beta manufacturing and formulation development in the world, and is therefore the best partner for Faron’s Traumakine® project", comments Klaus Schoepe, Senior Vice President Client Relations of Rentschler.
"We bring to this product our process of IFN-beta manufacturing together with our capacity to finalize the Faron product and are very motivated to aid Faron in bringing Traumakine® to global markets in this new indication ALI/ARDS", continues Schoepe.