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Published on : Sunday, November 17, 2013
Gentium S.p.A. and Link Healthcare today announced that Defibrotide has been designated as an Orphan Drug for the Treatment of Hepatic Veno-Occlusive Disease (VOD).The sponsor of Defibrotide is Link Healthcare, Gentium’s exclusive distribution partner in Australia.
The main characteristics of the orphan drug policy in Australia are:
It is intended for drugs which aim to treat diseases with a prevalence of 2,000
patients/subjects or less in the Australian population (23 million).It allows for a waiver of application and evaluation and no annual registration fees.It provides five-year period of exclusivity (under consideration by the Australian jurisdiction).
Gentium will now work with Link to commence the Marketing Application process in