Pharmaprojects R&D Pipeline News Feed
Once-daily mesalamine receives first approval in the US for ulcerative colitis
6th Feb 2007
Shire has received its first US approval in 2007 for Lialda - a once-daily preparation of mesalamine prepared with the gastro-resistant MMX technology –for the induction of remission of patients with active, mild-to-moderate ulcerative colitis, and plans to launch the compound this quarter.
Private company Giuliani licensed exclusive development and US commercialization rights for the mesalamine formulation to Shire, in addition to Canada, Europe and the Pacific Rim, retaining rights for its own market, Italy.
Lialda contains 1.2g of mesalamine reducing the number of tablets that suffers have to take, and is the first new mesalamine option available since 2000. Other candidates following Lialda in Phase III development include Alizyme’s modified-release prednisolone metasulfobenzoate sodium and visilizumab, a humanized CD3-specific monoclonal antibody, which PDL BioPharma plans to file a US BLA for in 2008.
