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European Filings Of SPD476 (Mesalazine) For Treatment Of ...

...If approved, SPD476 would offer a once-daily mesalazine treatment for active mild to moderate "The European submissions for SPD476 represent the achievement of another important milestone for Shire," said Shire Chief Executive Matthew Emmens.

"Currently there is no once-daily oral treatment for As previously announced, Shire submitted a New Drug Application for SPD476 to the U.S.

Food & Drug Administration in December 2005.

Shire also recently filed a New Drug Submission for SPD476 with Health Canada.

SPD476 is the only Shire has licensed from Giuliani S.p.A.

the exclusive rights to develop and commercialize SPD476 in the US, Canada, Europe (excluding Italy) and the Pacific Rim.

Giuliani S.p.A.

retains the development and commercialization rights to SPD476 in Italy.

MMX was developed by Cosmo S.p.A.

SPD476 SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalazine) in a delayed and extended release formulation (MMX) being studied for the induction and maintenance of remission of active, mild-to-moderate ulcerative colitis....

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