Shire will launch Mezavant XL, the first once daily mesalazine tablet, in the UK on 5 November. Mezavant XL is approved for the induction of clinical and endoscopic remission in mild to moderate, active ulcerative colitis. Mezavant XL is also approved to maintain remission in ulcerative colitis.
Patients with ulcerative colitis endure bouts of bloody diarrhoea, abdominal pain and other unpleasant symptoms. Mesalazine (also called 5-aminosalicylic acid), a mainstay of treatment for this distressing, debilitating disease, is available in a variety of formulations. Mezavant XL uses Cosmo Technologies’ MMX (Multi-Matrix System) drug delivery technology to deliver mesalazine throughout the colon with once-daily dosing.
Mezavant XL contains mesalazine 1200mg and is taken as a once daily dose of two to four tablets. Shire contrasts this regimen with most current treatments for ulcerative colitis that are taken several times a day. Potentially such regimens could undermine compliance. Indeed, surveys suggest that up to 65% of patients with ulcerative colitis adhere poorly to their medication.
Mezavant XL appears effective. For example, Mezavant XL approximately doubles the likelihood of inducing remission compared with placebo. In an 8-week trial that enrolled patients with active, mild to moderate ulcerative colitis, 41.2% and 40.5% of patients taking Mezavant XL 4.8g and 2.8g once daily respectively achieved clinical and endoscopic remission. This compares with 22.1% of the placebo group.
The ulcerative colitis market is potentially lucrative. According to guidelines published by the British Society of Gastroenterology (BSG), the incidence (number of new cases) of ulcerative colitis is approximately 10–20 per 100 000 of the population annually. The prevalence (total number of cases) is between 100 and 200 per 100 000. Around half of ulcerative colitis patients experience at least one relapse in any year. Shire launched the US version of MMX mesalazine (Lialda) on March 19 this year. Lialda achieved a 4.2% US market share by July 13. In the UK, Mezavant XL seems competitively priced at about a pound a tablet (£62.44 for 60 tablets).
Shire licensed the exclusive rights to develop and commercialise MMX mesalazine in the USA, Canada, Europe (excluding Italy) and the Pacific Rim from Giuliani S.p.A. Shire markets or plans to market MMX mesalazine as Mezavant XL in the UK and Ireland, Mezavant LP in France, Mezavant in Canada and certain other European Union countries, and Lialda in the USA. Giuliani will develop and commercialise MMX mesalazine in Italy, and South and Central America.