ECJ overturns German market approval over similarity to orphan drug

Published: 30-Jun-2015

ASK Pharmaceuticals will see approval for Kolbami – Cholic Acid scrapped


A French pharmaceutical manufacturer has persuaded the General Court of the European Court of Justice (ECJ) to overturn a European Union (EU) medicine marketing approval secured by a German company, because the two drugs were too similar.

Laboratoires CTRS, located in Boulogne-Billancourt, France, persuaded judges to scrap an approval held by ASK Pharmaceuticals, of Munich. It holds approval rights originally granted last April (2014) to Germany’s FGK Representative Service for ‘Kolbam — Cholic Acid’, used to treat rare liver disorders. But the French company challenged this decision, arguing that the medicine was too similar to ‘Orphacol (Cholic Acid)’, approved by the European Commission as an orphan medicinal product in September 2013. It is authorised for treating inborn errors of primary bile acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency.

Laboratoires CTRS said references to Orphacol therapeutic indications in the Kolbam summary of product characteristics 'amounted to a circumvention of the market exclusivity attaching to Orphacol'.

Judges have now backed the French company’s request that ASK’s market approval be scrapped, noting that 'statements concerning the efficacy of Kolbam for the Orphacol therapeutic indications or for all inborn errors of primary bile acid synthesis…are liable to facilitate the off-label prescribing of Kolbam for the Orphacol therapeutic indications…'.

The court also ordered that the Commission pays Laboratoires CTRS’ legal costs.

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