New Data Presented at UEGW Confirm Effectiveness and Safety of RESOLOR(R) for Patients With Chronic Constipation

Geschrieben am 30-10-2007

Paris (ots/PRNewswire) -

- Novel Compound Offers Hope to Patients not Adequately Responding
to Laxative Treatment

Data presented for the first time today at the international
gastroenterology meeting UEGW (United European Gastroenterology Week)
confirm the effectiveness and safety of RESOLOR(R) (prucalopride), a
novel and selective, high-affinity 5-HT(4) receptor agonist, for
patients suffering from Chronic Constipation (CC) for whom laxatives
do not provide adequate relief(1).

Findings from this randomised, double-blind, placebo-controlled
trial evaluating the effectiveness and safety of RESOLOR (2 mg and 4
mg) in patients with CC over 4 and 12 weeks demonstrated similar
results for both doses, which were significantly different from
placebo (p is less than or equal to 0.01) at the primary endpoint,
where the proportion of patients treated with RESOLOR having an
average of greater than or equal to 3 spontaneous complete bowel
movements (SCBM) more than doubled, over 4 and 12 weeks, versus the
placebo group. RESOLOR also reduced perceived severity of symptoms,
improved disease-related quality of life (QOL), and was safe and
well tolerated.

Lead investigator Jan Tack, Professor and Head of Clinic, Division
of Gastroenterology, University Hospital Gasthuisberg, University of
Leuven, Belgium, commented "If not treated appropriately, CC can have
a significant impact on patients' well-being. The debilitating
effects on work, mental health and relationships are often
underestimated. Achieving three or more spontaneous complete bowel
movements per week for a patient with CC can be considered a return
to a normal bowel frequency. The data therefore confirm that
treatment with RESOLOR, for this difficult to treat patient
population, resulted in normalisation in approximately 25% of
patients and a clinically meaningful improvement in an additional
20%. This is a clear step forward in treating a population in need of
effective treatments."

Dirk Reyn, CEO of Movetis, added "At Movetis we are committed to
discover and develop products targeting gastrointestinal conditions
previously neglected by innovation. These convincing Phase III data
demonstrate that RESOLOR can really make a difference for the
millions of patients who have tried laxatives without success. We are
planning to file RESOLOR for European marketing approval in

About the trial

This Phase III trial, the first of three identical, multicentre,
parallel-group, randomised, double-blind, placebo-controlled trials,
evaluated 713 patients (90.8% female, mean age approximately 43
years), with long-standing (at least 18 years of disease history on
average) and more severe CC (less than 2 SCBM/week) with straining or
sensation of incomplete evacuation or with hard stools. The primary
objective was to assess the proportion of patients reporting on
average three or more SCBM/week during 4 weeks and the 12-week
treatment period - a very stringent primary endpoint, as agreed with
the European Health Authorities. At inclusion, patients had less
than 2 SCBM per week and more than 80% declared that previous
treatment with laxatives did not provide adequate relief. Patients
received oral doses of 2 mg or 4 mg RESOLOR, once daily, for 12
weeks. Percentages of patients with greater than or equal to 3
SCBM/week averaged over 4 and 12 weeks were:

- 10.4% and 9.6% for placebo
- 23.7% and 19.5% for 2 mg RESOLOR
- 26.6% and 23.6% for 4 mg RESOLOR.

The following secondary objectives were significantly improved
with 2 mg RESOLOR versus placebo (averaged over the 4- and 12-week
treatment periods):

- percentage of patients with an increase of one or more SCBM/week (41.0%
vs. 20.9% and 38.1 vs. 20.9%, respectively; p is less than or equal to
- percentage of bowel movements with normal consistency (p is less than
or equal to 0.05)
- percentage of BM with no straining (p is less than or equal to 0.01)
- perceived severity of constipation (p is less than or equal to 0.001)
- overall PAC-SYM scores (p is less than or equal to 0.001).
- overall treatment satisfaction scores (p is less than or equal to 0.001)

Similar findings (all statistically significant) were observed
with 4 mg RESOLOR.

RESOLOR was reported safe and well tolerated, and no drug-related
serious cardiac events were reported.


RESOLOR is a novel enterokinetic treatment for CC in a patient
population not adequately relieved by laxative treatments. It is a
selective, high-affinity 5-HT(4) receptor agonist, which increases
colon motility and restores the slow movement of the bowels in a
dose-dependent manner. RESOLOR has now completed three Phase III
studies and been tested in more than 3,000 patients. Movetis is
planning to file for European marketing approval in mid-2008.

About Chronic Constipation (CC)

CC is a disorder of the gastro-intestinal (GI) tract. It is a
prevalent and debilitating condition that is not always well
understood and is in many cases inadequately treated. Different
guidelines define CC as less than 3 bowel movements per week for at
least 6 months. This is usually accompanied by pain and or excessive
straining during the passage of a bowel movement. Patients often
complain that stools are either too hard, too infrequent, too
difficult to pass or incomplete and therefore unsatisfactory(2). In
Europe, an estimated 8.5 million patients frequently visit their
doctors with complaints of constipation after dissatisfactory
results with over-the- counter medication(3). Constipation is more
common in women than men (estimated prevalence ratio of 2.2:1)(4).
However, the true prevalence of CC is often underestimated since not
all patients seek medical advice.

About Movetis

Through a clear focus on GI, Movetis seeks to improve the lives of
millions of patients - both adults and children - by discovering,
developing and commercialising innovative treatments targeting GI
conditions previously neglected by innovation. Movetis NV - founded
in Belgium in December 2006 - aims to become the leading European
specialty pharmaceutical organisation focused on GI diseases. Movetis
has a broad GI portfolio with four products in clinical development
and four in preclinical, all addressing important areas of unmet
medical need, including CC, ascites, paediatric reflux, diabetic
gastroparesis, severe forms of dyspepsia and secretory diarrhoea. In
addition, Movetis owns a large library of qualified lead compounds
with potential for development. The current portfolio has been
licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil
Pharmaceutical Inc., two Johnson & Johnson (J&J) companies.

The current clinical portfolio includes:
- RESOLOR (prucalopride), a compound for the treatment of CC currently in
- M0002, a compound for the treatment of ascites, currently in Phase II
- M0003, a gastrokinetic compound for the treatment of paediatric reflux
and gastroparesis, which will enter Phase IIa clinical trials in Q1 2008
- M0004, another gastrokinetic compound for motility complaints related
to gastro-oesophageal reflux disease (GORD).

In 2006, Movetis secured 49 million Euros in a series 'A'
financing from major European and US investors - one of the biggest
series 'A' rounds in Europe. These funds are being used to complete
the development and registration filing of RESOLOR, and to continue
preclinical and clinical development of all other products. Investors
include Sofinnova Partners, J&J, Life Sciences Partners, Sofinnova
Ventures, KBC Private Equity and KBC Private Equity Fund Biotech,
GIMV, Quest for Growth and BIP Investment Partners. Movetis is based
in Turnhout, Belgium.


(1) J. Tack, G. Tan, L. Vandeplassche. A randomized, double-blind,
placebo-controlled trial to evaluate efficacy and safety of
prucalopride in patients with chronic constipation. Abstract
OP-G-377, UEGW 2007.

(2) P. Pare, S. Ferrazzi, W.G. Thompson, et al. An epidemiological
survey of constipation in Canada: definitions, rates, demographics,
and predictors of health care seeking. Am J Gastroenterol

(3) IMS Health.

(4) Higgins PD, Johanson JF. Epidemiology of constipation in North
America: a systematic review. Am J Gastroenterol 2004;99:750-9.

Visit http://www.movetis.com/news.aspx to download the press
release (Tuesday 30 October 2007, from 14.00 CET)

ots Originaltext: Movetis NV
Im Internet recherchierbar: http://www.presseportal.de

For further information contact Axon Communications: Ludivine
Delattre, Tel: +44-(0)20-8439-9477, ldelattre@axon-com.com; Sarah
Griffin, Tel: +44-(0)20-8439-9582, sgriffin@axon-com.com


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