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Movetis obtains EU authorisation for the commercialisation of Resolor® (prucalopride). First launch of Resolor anticipated in Q1 2010.

Publiée le 22/10/2009

Turnhout, October 22, 2009 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.”

About Movetis
Through a clear focus on gastroenterology (GI), Movetis seeks to improve the lives of millions of patients – both adults and children – by discovering, developing and ultimately commercializing innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV – founded in Belgium in December 2006 – aims to become a leading European specialty pharmaceutical organization focused on GI diseases. Movetis has a broad GI portfolio: Resolor® (prucalopride), is now approved in the EEA for the indication “symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief”; two products in Phase II development and two prioritised compounds in preclinical development, all addressing important GI areas including chronic constipation, ascites, paediatric reflux in infants, refractory GORD (gastroesophageal reflux disease) and severe forms of irritable bowel syndrome. In addition, Movetis has rights to a large library of qualified lead compounds with potential f r development in various GI indications and access to know how relating to compounds in secretory diarrhoea. The current portfolio is licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two Johnson & Johnson companies.

About chronic constipation
Chronic constipation is a general disorder of the gastrointestinal tract that affects an estimated 300 million worldwide, 80 million people in the Western World and at least 34 million in Europe, with more than 80% of the patients visiting a doctor being female (IMS Health data , Prevalence model ). The ROME III guidelines define chronic constipation as two or more of the following symptoms at least a quarter of the time for at least six months: straining, lumpy or hard stools, a sensation of incomplete evacuation, a sensation of anorectal obstruction or blockage, and/or less than 3 defecations per week (Longstreth et al, 2006 ). A recent survey in US patients revealed that nearly half of the respondents (47%) were not completely satisfied with constipation relief therapy, mainly because of efficacy (82%) and safety (16%) concerns (Johanson and Karlstein 2007 )

About prucalopride
Prucalopride (Resolor®) has been granted a Marketing Authorisation by the European Commission for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. The Patient Information Leaflet and Summary of Product Characteristics can be found on the EMEA website.

References
Irvine EJ, Ferrazzi S, Pare P, Thompson WG, Rance L. Health-related quality of
life in functional GI disorders: focus on constipation and resource utilization. Am

Glia A, Lindberg G. Quality of life in patients with different types of functional
constipation. Scand J Gastroenterol 1997; 32: 1083-1089.
Damon H, Dumas P, F. M. Impact of anal incontinence and chronic constipation
on quality of life. Gastroenterol Clin Biol 2004; 28: 16-20.
Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride
(Resolor) in the treatment of severe chronic constipation in patients dissatisfied
with laxatives. Gut 2009;58:357-65.
Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F.
Spiller, R. C. Functional Bowel Disorders. Gastroenterology 2006; 130 (5): 1480-
91
Johanson J and Karlstein J. Chronic Constipation: a survey of the patient
perspective. Aliment Pharmacol Ther 2007;25:599-608
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