Under the pact, Rentschler is expected to take up the responsibility of the sole global manufacturer of IFN-beta 1a for Faron and it will also manufacture Faron’s proprietary bulk drug product.
Traumakine is meant to prevent vascular leakage in patients with acute lung injuries (ALI) and its more severe form ARDS.
Faron CEO Markku Jalkanen said 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.
Rentschler Client Relations senior vice president Klaus Schoepe said they bring to this product their process of IFN-beta manufacturing together with their 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.