Resolor (prucalopride), a new prescription drug for the treatment of chronic constipation in women, is now available in the UK.
The drug, which is produced by Movetis, a gastrointestinal speciality company based in Belgium, is described as a novel enterokinetic agent that represents a new approach to the symptomatic treatment of constipation in women for whom laxatives have failed to provide adequate relief because of underlying impaired gut motility. Resolor addresses this problem, says Movetis, which notes that an estimated 35%-50% of the total patient population being treated with laxatives are not receiving adequate relief.
Resolor’s clinical development programme has involved more than 3,000 patients being treated for the equivalent of over 2,600 patient years, and it received its first market launch, in Germany, on January 27. The firm also expects to launch the product in the Netherlands this year, and to introduce it in France and Belgium, including Luxembourg, in 2011.
Reactions to Resolor from key gastroenterologists in Germany are “very encouraging,” said Movetis’ chief executive, Dirk Reyn, who adds that, with the drug’s UK market introduction, the firm “is now present in two of the five European markets where we intend to build our own commercial organisations.”
The drug is available in the UK at an approved Basic NHS price of £2.13 per tablet for the 2mg version and £1.38 per tablet for the 1mg version, and the firm says it is currently in negotiation with the National Institute for Health and Clinical Excellence (NICE) concerning a Single Technology Assessment (STA) process for its product.
It is also continuing to seek commercial partnerships to roll out Resolor in the European Economic Area (EEA) beyond these five markets, and to work with Johnson & Johnson (J&J) to prepare for the drug’s filing and eventual launch outside Europe. Movetis was founded in Belgium in November 2006 as a spin-off from J&J.
Resolor is approved in the EEA – 27 European Union (EU) member states plus Norway, Iceland and Liechtenstein – for the “symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief,” and a marketing authorisation application is currently under review in Switzerland.
The firm points out that it has set up a collaboration with IDIS of the UK to provide pre-launch access to Resolor in those countries where the product has received marketing approval but where the pricing and reimbursement procedures are still ongoing, and where this is allowed by national regulations.
Movetis’ current portfolio is licensed from Janssen Pharmaceutica of Belgium and Ortho-McNeil Pharmaceutical. In addition to Resolor, it says, it has two products in Phase II development and two prioritised compounds in preclinical development, all addressing GI areas including ascites, paediatric reflux, refractory gastroesophageal reflux disease (GORD) and severe forms of irritable bowel syndrome. The firm also has rights to a large library of qualified lead compounds with potential for development in different GI indications, plus access to know-how for compounds in secretory diarrhoea.
