EU court to rule on SangStat's SangCya

Novartis claims that data filed for Neoral (cyclosporin) in the UK hasbeen inappropriately used by the Medicines Control Agency in order to facilitate the approval of SangStat's SangCya oral solution, a generic equivalent to Novartis' liquid formulation of Neoral.

Neoral, which is used to prevent rejection in kidney, liver and heart transplant patients, as well as treating some autoimmune diseases, has been available in the UK for six years. SangCya was launched in the USA in 1998, but was recalled after a negative bioequivalence study (Marketletter July 17, 2000). Novartis' claims have led the UK Court of Appeal to refer the final decision on the marketing authorization of SangCya in the UK to the European Court of Justice.