Santhera Pharmaceuticals Holding AG : Santhera Initiates Collaboration with
the European Vision Institute Clinical Research Network in LHON
Santhera Pharmaceuticals Holding AG / Santhera Initiates Collaboration with
the European Vision Institute Clinical Research Network in LHON . Processed
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Liestal, Switzerland, July11, 2013 - Santhera Pharmaceuticals (SIX:SANN)
announced today 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.
"Lack of natural history data is a general shortcoming in clinical research of
rare diseases and a limitation in the development of orphan drugs", commented
Thomas Meier, CEO of Santhera. "We have initiated this collaboration with
EVICR.net to increase our understanding of changes in vision in LHON patients,
including spontaneous recovery after severe vision loss. We expect to
integrate these data as a comparator group in a revised MAA for Raxone^® in
the treatment of LHON that we plan to submit as early as the first quarter
"We are excited about this collaboration and the opportunity to support
Santhera in the collection of natural history data", added José-Alain Sahel,
Professor at the Université Pierre et Marie Curie, Director of the Institut de
la Vision, Chairman at the Centre Hospitalier National d'Ophtalmologie des
Quinze-Vingts (Paris, France) and Chairman of EVICR.net. "EVICR.net was
established as European consortium to promote academic translational research
and support industry in conducting clinical research, including assessment of
natural history data, which is of particular relevance in rare diseases such
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.
Leber's Hereditary Optic Neuropathy (LHON) is a heritable genetic disease
causing blindness. The disease typically presents in young adults, mostly men,
as rapid, painless loss of central vision in one eye, followed by visual loss
in the fellow eye within a few months of the onset of symptoms, leading to
blindness. Over 95% of patients harbor one of three pathogenic mutations of
the mitochondrial DNA which cause a defect in the complexI subunit of the
mitochondrial respiratory chain. This defect leads to decreased cellular
energy (ATP) production, increased oxidative stress and retinal ganglion
dysfunction which cause progressive loss of visual acuity and blindness.
Santhera develops Raxone^® (idebenone) as treatment for patients with LHON.
The synthetic short-chain benzoquinone and a cofactor for the enzyme
NAD(P)H:quinone oxidoreductase (NQO1) is capable of transferring electrons
directly onto complex III of the mitochondrial electron transport chain,
thereby circumventing the complexI defect and restoring cellular energy
levels in retinal ganglion cells and promoting recovery of visual acuity.
* * *
Santhera Pharmaceuticals (SIX:SANN) is a Swiss specialty pharmaceutical
company focused on the development and commercialization of innovative
pharmaceutical products for the treatment of orphan mitochondrial and
neuromuscular diseases, areas of high unmet medical need with no current
therapies. For further information, please visit www.santhera.com.
Raxone^® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Executive Officer
Phone: +41 61 906 89 64
Disclaimer / Forward-looking statements
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publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
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