German contract manufacturer first produced product in 1980s
German contract manufacturer Rentschler Biotechnologie has signed a manufacturing agreement with Finland-based drug discovery firm Faron Pharmaceuticals to supply FP-1201 (Traumakine).
The active pharmaceutical ingredient of FP-1201 is recombinant human interferon beta-1a (IFN-beta 1a), which was first produced by Rentschler in the late 1980s. According to the terms of the agreement, Rentschler will become sole manufacturer of IFN-beta 1a for Faron and also manufacture Faron’s proprietary bulk drug product.
Traumakine prevents vascular leakage in patients with acute lung injuries (ALI) and its more severe form ARDS. It is currently in a Phase I/II study in the UK.
Financial details of the agreement were not disclosed.
‘This agreement allows Faron to move to final clinical development stage of Traumakine, and to file a marketing authorisation application to the European Medicines Agency (EMA) following a pan-European trial in 2012–14,’ said Faron’s chief executive Markku Jalkanen.
Klaus Schoepe, senior vice president Client Relations at Rentschler, added: ‘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.’
Faron has already been granted orphan drug status for FP-1201 in ALI/ARDS by the European Commission and European Medicines Agency (EMA). The firm has also been granted several patents both in the US and Europe for this new use of IFNs to treat various ischemic conditions.