Shire Pharmaceuticals of the UK has submitted a dossier seeking approval for its investigational drug for mild-to-moderate ulcerative colitis, SPD476, in Europe.

If approved, SPD476 would offer a once-daily mesalazine treatment for active mild-to-moderate ulcerative colitis. This compound is widely used in the treatment of ulcerative colitis but at present has a major drawback in that it must be delivered at a very high dose that requires multiple tablets to be taken each day.

As a once-daily product, SPD476 could be a strong contender in the world market for mesalazine products used for ulcerative colitis, currently valued at around $1.6 billion a year. Shire is already active in this therapeutic segment, as it sells two other ulcerative colitis drugs - Pentasa (mesalamine) in the USA and Colazide (balsalazide) in the UK.

The new formulation of mesalazine uses a drug delivery technology developed by Italian firm Cosmo SpA, called MMX, which is designed to allow the targeted delivery of active compounds to specific areas of the gastrointestinal tract. Shire licensed SPD476 from Cosmo and its commercial partner for the product, Giuliani SpA, in 2002.

Shire filed for approval of SPD476 in the USA in December 2005 under the trade name Mesavance, and said at the time it is hoping to launch the product by the end of this year. The company has rights to SPD476 in the USA, Canada, Europe (excluding Italy) and the Pacific Rim.