Shire plc (BASINGSTOKE, United Kingdom), the third largest pharmaceutical company in the UK, announced that core labeling information, part of Shire's Marketing Authorization Application for the ulcerative colitis (UC) treatment Mezavantâ„¢ (mesalazine, once-daily, high-dose 5-aminosalicylic acid (5-ASA) in a delayed and extended release formulation), has been agreed by the regulatory agencies for the 15 European countries (including Germany, France, Spain, and the United Kingdom) participating in the decentralized procedure. Following closure of the decentralized procedure, associated national approvals should follow in the first quarter of 2007, enabling Shire to make a phased launch of Mezavant in Europe.

Mesalazine is used as a first-line treatment for mild-to-moderate UC and is the only treatment that utilizes Multi Matrix Systemâ„¢ (MMX) drug delivery technology to provide gastroresistant, prolonged release of mesalazine throughout the colon in a once-daily dose single strength tablet. Mezavant, containing mesalazine 1200 mg (the highest dose per tablet), will be indicated both for the induction of clinical and endoscopic remission in patients with mild-to-moderate active UC, and for maintenance of remission. In 2005, over 450,000 patients were identified to be suffering with UC in Europe. In the US, the new drug application (NDA) was submitted to the FDA on December 22, 2005, and the PDUFA (Prescription Drug User Fee Act) date is January 21, 2007.

In two phase III clinical studies, Shire's delayed and extended release version of 5-ASA induced remission of mild-to-moderate active UC in patients who were changed from other oral 5-ASA therapies and in patients who were 5-ASA naïve. Additionally, mesalazine induced remission of left-sided or extensive UC in patients, which affects the colon below the splenic flexure. The current 5-ASA treatments often require multiple daily oral dosing or enema administration, which may impact patient compliance.

Shire in-licensed the exclusive rights from Giuliani SpA to develop and commercialize Mezavant in the US, Canada, Europe (excluding Italy), and the Pacific Rim. Giuliani SpA developed Mezavant from proof-of-concept to phase IIa and retains the development and commercialization rights in Italy and in South and Central America. Cosmo Pharmaceuticals SpA, in Milan, Italy, developed the MMX technology and owns the trademark, as well as the drug delivery and process patents covering mesalazine.

—A. Techman

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