Date: 2013-07-11
Type of information: Collaboration agreement
Compound:
Company: Santhera Pharmaceuticals (Switzerland) European Vision Institute Clinical Research Network
Therapeutic area: Rare diseases - Genetic diseases - Ophtalmological diseases
Type agreement: collaboration
Action mechanism:
Disease: Leber\'s Hereditary Optic Neuropathy (LHON)
Details: * On July 11, 2013, Santhera Pharmaceuticals has announced that it has initiated a collaboration with the European Vision Institute Clinical Research Network (EVICR.net) to assess the natural course of Leber\'s Hereditary Optic Neuropathy (LHON). Data from this collaboration is intended to be included in a marketing authorization application (MAA) for Raxone® (idebenone) in Europe.
Under the collaboration, Santhera will receive data on the change in vision over time in untreated LHON patients from selected EVICR.net centers. This data will be compared to the vision outcomes data currently being collected from physicians around the world who are treating LHON patients with Raxone® in clinical practice.
European Vision Institute Clinical Research Network (EVICR.net) was established in 2010 as an independent European Economic Interest Grouping to serve as a platform for clinical trial research in ophthalmology in Europe. It is a network of 76 European ophthalmological clinical research sites in 16 European countries dedicated to perform clinical research in ophthalmology with the highest standards of quality, following the European and international directives for clinical research according to harmonized standard operating procedures.
Financial terms:
Latest news:
