Defibrotide is an investigational drug indicated to treat and prevent veno-occlusive disease (VOD).
As part of the agreement, Medison will manage the named-patient sales program, local registration, authorization, marketing, reimbursement, and medical affairs in these territories.
Defibrotide has been granted orphan drug status by the US Food and Drug Administration (FDA) and orphan medicinal product designation by the European Commission both to treat and to prevent VOD and fast track designation by the FDA to treat VOD.
Gentium’s marketing authorization application for defibrotide was recently accepted by the European Medicines Agency and was granted an accelerated assessment.
The company expects to file a new drug application with the FDA by the end of Q2 2011.
Following approval to market defibrotide, if any, Medison will have the exclusive right to promote, purchase, market and sell defibrotide in these territories.