Santhera Confident Of Raxone DMD Success Despite Setbacks
The Swiss company believes it has collected sufficient new data on Raxone for Duchenne muscular dystrophy to convince regulators and hopes to file for that indication on both sides of the Atlantic by the end of the first quarter of 2019.
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Santhera needs more time to address concerns regarding its current EU application for idebenone in the DMD setting but the Swiss biotech is keeping its sights on a broader indication.
In a deal that could be worth CHF105m, the Swiss biotech has outlicensed Raxone to Chiesi for the rare eye disease LHON as it concentrates on the drug's filing for Duchenne muscular dystrophy.
Despite being knocked back twice, Santhera CEO Thomas Meier is still confident Raxone has a place as a Duchenne muscular dystrophy therapy, and believes new long-term data will strengthen its third application to the EU in the coming months.