21 December 2011 - US speciality biopharmaceutical firm Santarus Inc (NASDAQ:SNTS) announced on Tuesday it had filed a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for UCERIS (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis.

UCERIS is a locally acting, nonsystemic corticosteroid in a new, patented, oral tablet formulation, which uses the company's MMX multi-matrix system technology for controlled release and distribution of budesonide throughout the length of the colon.

UCERIS is being developed in partnership with Cosmo Technologies Ltd, part of Cosmo Pharmaceuticals SpA. Cosmo Technologies is due to receive a USD4m (EUR3m) milestone payment in cash or Santarus common shares at Cosmo's option after the FDA accepts for review the NDA for UCERIS Tablets.

UCERIS was assessed for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III multicentre, randomised, double-blind, double-dummy, placebo-controlled four-arm trials conducted in Europe, USA and India. In these studies, UCERIS 9 mg administered once daily achieved the primary endpoint of superiority to placebo (p=0.0143 in US trial and p=0.0047 in EU trial) in attaining clinical remission in the intent-to-treat (ITT) population as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of therapy.

The Phase III clinical trial results also showed that UCERIS 9 mg was generally well tolerated and the frequency of treatment-triggered adverse events was comparable to placebo.

(USD1 = EUR0.759)