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news.Santhera Pharmaceuticals has signed a distribution and supply agreement with Ewopharma for Raxone covering Eastern European countries and the Baltics.
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Raxone is indicated to treat Leber’s hereditary optic neuropathy (LHON), a heritable genetic disease causing blindness.
The deal will enable Santhera to launch Raxone in Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Estonia, Latvia and Lithuania.
Santhera chief commercial officer for Europe Giovanni Stropoli said: "The agreement with Ewopharma represents an important achievement for Santhera and underscores our commitment to making Raxone available to patients across all EU member states.
"We are confident that Ewopharma’s expertise in the field of rare diseases, coupled with their understanding of the region, will greatly benefit patients with this devastating disease."
Idebenone is being developed in several orphan mitochondrial and neuromuscular indications. It is a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H: quinone oxidoreductase (NQO1).
It is capable of transferring electrons directly onto complex III of the mitochondrial electron transport chain, thereby circumventing the complex I defect and restoring cellular energy levels.
Raxone authorized at a daily dose of 900 mg (given as 2 tablets three times a day with food), for the treatment of visual impairment in adolescent and adult patients with LHON, which is mostly found in young, otherwise healthy adult males as rapid, painless loss of central vision.