Shire submits NDA for Mesavance to treat ulcerative colitis

By E. Janene Geiss

Philadelphia, Dec. 22 - Shire plc said Thursday that it has submitted a New Drug Application to the Food and Drug Administration for Mesavance (SPD476), an investigational compound being studied for the induction of clinical and endoscopic remission in patients with active, mild-to-moderate ulcerative colitis.

If approved, Mesavance would be the first available once-daily mesalamine treatment for active, mild-to-moderate ulcerative colitis, according to a company news release.

"The timely filing of our Mesavance NDA represents the fourth new product submission in 2005 for Shire and our partners," Shire chief executive Matthew Emmens said in the release.

Mesavance is the only ulcerative colitis treatment that uses novel MMX Multi Matrix System drug-delivery technology to provide delayed and extended-release of mesalamine throughout the colon.

Shire said it has licensed from Giuliani SpA the exclusive right to develop and commercialize Mesavance in the United States, Canada, Europe (excluding Italy) and the Pacific Rim.

The submission of a Marketing Authorization Application for Mesavance with the European Medicines Agency is planned for first-quarter 2006, officials said.

Giuliani SpA retains the development and commercialization rights to SPD476 in Italy. MMX was developed by Cosmo SpA.

Giuliani SpA is a privately owned specialty pharmaceutical company based in Milan, Italy.

Shire, based in Basingstoke, England, is a specialty pharmaceutical company.

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