The News

Movetis announces that Resolor® is now available in the UK

24/03/2010

European gastrointestinal (GI) speciality pharmaceutical company, announces that Resolor® (prucalopride) is now available in the UK for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.1

Resolor, a new way out for women with chronic constipation
Resolor (prucalopride) is a novel enterokinetic agent that represents a new approach to the symptomatic treatment of chronic constipation (in women in whom laxatives fail to provide adequate relief) as it targets underlying impaired gut motility.1 The clinical benefits and the favourable safety profile of Resolor in chronic constipation have been demonstrated in a clinical development programme with over 3,000 patients treated for the equivalent of more than 2,600 patient years.

1 Chronic constipation is characterised by infrequent and difficult passage of stools over a prolonged period and a range of bothersome symptoms. Traditional treatment options for chronic constipation consist mainly of dietary and lifestyle changes in combination with laxatives.

2 However, laxatives do not address the underlying problem in patients with chronic constipation due to impaired motility,3 and a number of patients are refractory to their current treatment.4 This explains why there is an important subgroup of patients (estimated at 35% to 50% of the total patient population treated with laxatives) who are not adequately relieved by currently available laxatives.

3 Eligible patients in the UK can now benefit from Resolor treatment UK wholesalers have been supplied with the product, and pharmacists can now dispense Resolor to patients who have received a medical prescription for this medicine. Resolor is available in the UK, at an approved Basic NHS price of £2.13 per tablet for the 2mg version (£1.38 per tablet for the 1mg version).

David Trevor, General Manager of Movetis UK, said: “We have been working with key opinion leaders in the UK regarding Resolor since February, and we are already looking forward to tomorrow’s satellite symposium at the British Society of Gastroenterology meeting, in Liverpool. The annual scientific meeting of the BSG offers a unique platform for presenting Resolor to the specialist community in the UK with an expected audience exceeding 2000 GI specialists and associated health care professionals.”

A next step in the widespread endorsement of Resolor will follow with the closing of ongoing negotiations with the National Institute of Clinical Excellence (NICE) about the Single Technology Assessment for the product.

1 SmPC. Summary of product characteristics Resolor (prucalopride). October, 2009
2 WGO Practice Guidelines – www.medscape.com
3 Johanson & Kralstein. Aliment Pharmacol Ther 2007; 25:599
4 Mertz H, Naliboff B, Mayer E. Am J Gastroenterol 1999; 94:609-15.

Resolor’s European market introduction scheme
The UK is the second country where Resolor has been introduced on the market.
Resolor is available in Germany since 27 January 2010.

Dirk Reyn, CEO of Movetis, commented: “Reactions from key gastroenterologists to Resolor in Germany are very encouraging. With today’s market introduction in the UK,
Movetis is now present in two of the five European markets where we intend to build our own commercial organisations. As in Germany, we have been able to attract a highquality core team in the UK with significant experience in launching pharmaceutical products. I am confident that this team too can optimise the full commercial potential of Resolor and further develop our local UK organisation.”

Later in 2010, Movetis expects to launch Resolor in the Netherlands and to continue the preparations for the product launch in France and Belgium (including Luxemburg) in 2011.

In addition, Movetis is continuing to pursue its strategy of seeking commercial partnerships to roll-out Resolor in the European Economic Area beyond these five markets. Movetis is also continuing to work with Johnson & Johnson to prepare for the filing and eventual launch of Resolor outside Europe.

Movetis has set up a collaboration with the UK-based company IDIS in order 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. Doctors and pharmacists can contact IDIS for more information (www.idispharma.com).

About Movetis
Movetis is a European specialty GI company focused on improving the lives of millions of patients – both adults and children – by discovering, developing and commercialising innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV was founded in Belgium in November 2006 as a spin-off of Johnson & Johnson.

Movetis has a broad portfolio of GI products: Resolor® (prucalopride) is approved in the European Economic Area (27 EU member states, Norway, Iceland and Liechtenstein) for the indication “symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief”. The marketing authorisation application is currently under review in Switzerland. Two products are in Phase II development and
Movetis has two prioritised compounds in preclinical development, all addressing important GI areas including ascites, paediatric reflux, 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 for development in different GI indications and access to know how for compounds in secretory diarrhoea.

The current portfolio is licensed from Janssen Pharmaceutica NV, Belgium and Ortho- McNeil Pharmaceutical Inc., two Johnson & Johnson companies. Movetis shares are listed on Euronext Brussels under the ticker MOVE.

Forward-looking information
This document contains forward-looking statements and estimates with respect to the anticipated future performance of Movetis and the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the
financial condition, performance or achievements of Movetis, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forwardlooking
statements, forecasts and estimates only speak as of the date of the publication of this document.
Movetis disclaims any obligation to update any such forward-looking statement, forecast or estimates to
reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions
or circumstances on which any such statement, forecast or estimate is based, except to the extent required
by Belgian law.

For more information, please contact
Chris Van Raemdonck
Chris.Vanraemdonck@movetis.com
Tel: 0032/14/404.329 - Mobile: 0032/499/58.55.31