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Movetis, the GI specialty pharmaceutical company based in Belgium, announces that it has obtained approval from the European Commission for the commercialisation of its lead product Resolor (prucalopride – a 1mg and 2mg once a day oral tablet) for the symptomatic treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief.
Movetis will sell the product itself in certain European markets and expects the first launch in Q1 2010.
Chronic constipation is a general disorder of the gastrointestinal tract that affects approximately 34 million patients in EU27, with more than 80% of the patients visiting a doctor being female (IMS Health data, Prevalence model) “A Canadian national survey of randomly selected patients with functional constipation revealed a significant influence on the health-related quality of life (p<0.05)” (Irvine). Another publication states that “the general well-being of patients with chronic constipation is lower than that of a comparable normal population. Symptom severity correlates negatively with perceived quality of life” (Glia) and in a publication of Henri Damon we read: “Quality of life is profoundly altered both in patients with chronic constipation and incontinence” (Damon).
The approval by the European Commission means that Resolor is now approved for marketing in the 27 countries of the EU as well as Iceland, Liechtenstein and Norway.
A marketing authorisation application for prucalopride in Switzerland was submitted in June 2008 and is under review. A decision from the Swiss authorities is anticipated before mid 2010.
Staf Van Reet, Movetis’ Chairman, stated: “We are delighted with the decision of the European Commission to approve Resolor. The planned launch of our product will be an important step in our ambition to become a successful European speciality GI company.”
Dirk Reyn, CEO of Movetis, noted: “The EU approval is indeed a major milestone and achievement for Movetis which was only created in late 2006. It is the result of the hard work of many people including the Movetis team which comprises 37 passionate people as well as a group of experts from around the world. This achievement truly validates the expertise that Movetis has in bringing new GI drugs from discovery to marketing.”
Source: Movetis
Tags: new products
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