Movetis Presents New Data at Digestive Disease Week

San Diego (ots/PRNewswire) -

- Three Presentations and Four Additional Posters Reinforce
Efficacy and Safety Profile of RESOLOR

Movetis NV, a European-based GI specialist pharmaceutical
company, today announces that it has presented substantial new data
from different studies this week at the prestigious Digestive Disease
Week (DDW) 2008 Congress. The data, that are part of a comprehensive
development program with over 82 trials, reinforce the efficacy and
safety profile of RESOLOR(R) (prucalopride), the most advanced in the
class of novel and highly selective, high-affinity 5-HT4 receptor
agonists that has the potential to normalize impaired lower GI
motility. RESOLOR has been studied in the treatment of patients
suffering from chronic constipation for whom laxatives do not provide
adequate relief (1-7).

A combined analysis of three identical and pivotal phase III
studies, including 1,924 patients, demonstrated that over the 12
weeks treatment period both 2 mg and 4 mg RESOLOR significantly
improved bowel function (as measured by a number of rigorous primary
and secondary endpoints) as well as a variety of predominant symptoms
in patients with chronic constipation compared with placebo. These
results are also reflected in other efficacy parameters including
quality of life(1), adding support to RESOLOR data presented for the
first time at UEGW (United European Gastroenterology Week) in October
2007.

Additional data over 24 months (2) presented at DDW shows that
RESOLOR has a favourable safety profile and is well tolerated, and
that patients' satisfaction with bowel function was maintained during
this long treatment period (2). Furthermore, in a specifically
designed safety trial, RESOLOR showed favourable CV safety and
tolerability data (including comprehensive set of QTc measurements)
at repeated doses of up to 20 mg daily - 10 times the anticipated
therapeutic dose for chronic constipation (4).

Jan Tack, Professor and Head of Clinic, Division of
Gastroenterology, University Hospital Gasthuisberg, University of
Leuven, Belgium, and author of one of the abstracts, commented, "The
debilitating effects of chronic constipation on work, mental health
and relationships are often underestimated, and there is a recognised
and significant unmet need for an effective treatment with a novel
mechanism of action for this condition. RESOLOR's unique selectivity
means it is likely to be safer than older motility agents and more
effective than existing treatments, and may also potentially provide
a faster return to normalized bowel health. The variety and strength
of new RESOLOR data presented at DDW demonstrates how RESOLOR may
potentially help fill the unmet need and offer hope towards normal
bowel habits, symptom relief and improved quality of life to the many
patients who suffer from the condition."

Further data were also presented on treatment with RESOLOR of
various sub-populations of patients, where there remains a
significant challenge of treating chronic constipation. In these
studies, RESOLOR improved bowel function and was shown to be safe and
well tolerated in the elderly (5), in whom chronic constipation is a
common problem due to a combination of factors including reduced
colonic motility. It was also safe and well tolerated in a phase II
trial in Post Operative Ileus and in a phase II trial in those who
receive high dose opioid medication for chronic pain, and for whom
constipation is the most common and debilitating symptom. (6)

Staf Van Reet, Chairman of Movetis, added, "We are delighted that
all three presentations and four abstracts submitted to DDW were
accepted. The data, that are part of our overall and comprehensive
development program with RESOLOR, further supports the depth of the
data package, and illustrates our continued commitment to bring this
product to the market and to patients with chronic constipation.
Millions of people worldwide with constipation visit physicians
seeking help after unsatisfactory results with over-the-counter
medicines. RESOLOR is different from existing therapies in that it is
expected to not only improve bowel habits in a satisfactory way but
also to alleviate the broad range of symptoms in these patients with
minimal side effects. We believe RESOLOR helps address this
debilitating condition and may therefore improve the lives of these
patients, especially those who are more challenging to treat."

About the studies presented at Digestive Disease Week

Seven abstracts (three oral presentations and four posters) were
presented at DDW focusing on evaluating the efficacy and safety of
RESOLOR in a wide variety of patient populations with chronic
constipation (1-3,5-7), including patients that do not respond
adequately to laxatives, the elderly (5) and those with
opioid-induced constipation (6), and patients undergoing elective
partial colectomies (7). These studies assessed a wide range of
primary and secondary endpoints covering bowel movements, symptoms
and disease-related quality of life, including overall satisfaction
with treatment. RESOLOR was also investigated for impact on
cardiovascular variables (ECG, blood pressure, heart rate, QTc) in
healthy subjects at very high doses (4). In all populations, RESOLOR
had a favourable efficacy and safety profile.

About RESOLOR

RESOLOR is a novel enterokinetic treatment for chronic
constipation in a patient population not adequately relieved by
laxative treatments. It is a highly selective, high-affinity 5-HT4
receptor agonist, which increases colon motility and restores the
slow movement of the bowels in a dose-dependent manner. It is
intended to become available in film-coated tablets of 1 mg and 2 mg
for oral administration at a recommended dose level of 2 mg once
daily (o.d.) in adults. RESOLOR has completed three Phase III studies
and has been tested in more than 3,000 patients.

About chronic constipation

Chronic constipation is a disorder of the gastrointestinal tract.
It is a prevalent and debilitating condition that is not always well
recognized and understood and is in many cases inadequately treated.
The recent 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 (8). In Europe, an
estimated 10 million patients frequently visit their Doctors with
complaints of constipation after dissatisfactory results with
over-the-counter medication (9). Constipation is more common in women
than men (estimated prevalence ratio of 2.2:1)(10).

About Movetis

Through a clear focus on gastroenterology, 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 with four
products in clinical and four in preclinical development, all
addressing important GI areas with fewer innovative products,
including chronic constipation, ascites, reflux in infants, diabetic
gastroparesis, non-erosive and refractory reflux disease and
post-infectious IBS. In addition, Movetis owns a large library of
qualified lead compounds for further development addressing GI
disorders such as secretory diarrhoea. 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 chronic
constipation currently in final preparation for filing.
- M0002, a selective V2 receptor antagonist compound for the treatment of
ascites that has concluded a Phase IIa trial. Results are expected
before the end of Q2 2008.
- M0003, a gastrokinetic compound for the treatment of reflux in infants
and symptoms of gastroparesis, which has entered a Phase IIa clinical
trial in Q1 2008. - M0004, another gastrokinetic compound for motility
complaints related to non-erosive or refractory gastro-oesophageal
reflux disease (GORD).

References

1. Camilleri M et al. Efficacy of 12-week treatment with
prucalopride (Resolor(R)) in patients with chronic constipation:
combined results of three identical randomized, double-blind,
placebo-controlled phase III trials. Poster 435293, DDW 2008

2. Van Outryve MJ et al. Long-term follow-up study of oral
prucalopride (Resolor(R)) administered to patients with chronic
constipation. Poster 438541, DDW 2008

3. Tack JF et al. Safety and tolerability of prucalopride
(Resolor(R)) in patients with chronic constipation: pooled data from
three pivotal phase III studies. Poster 437976, DDW 2008

4. Boyce MJ et al. Cardiovascular safety of prucalopride
(Resolor(R)) in healthy subjects: results from a randomized,
double-blind, placebo-controlled, cross-over trial. Poster 430410,
DDW 2008

5. Mueller-Lissner SA et al. Randomized double-blind
placebo-controlled trial to evaluate efficacy and safety of
prucalopride (Resolor(R)) in elderly patients with chronic
constipation. Research Forum 438210, DDW 2008

6. Moulin DE et al. Randomized, double-blind, placebo-controlled
trial to evaluate efficacy and safety of prucalopride (Resolor(R)) in
patients with opioid-induced constipation. Topic Forum 438068, DDW
2008

7. Galandiuk S. Evaluation of the efficacy, safety and
tolerability of prucalopride (Resolor(R)) given subcutaneously in
patients undergoing elective partial colectomies. Research forum
438293, DDW 2008

8. Drossman A. Rome III: The new criteria. Chinese Journal of
Digestive Diseases 2006; 7 (4): 181-185.

9. IMS Health

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

ots Originaltext: Movetis
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