Movetis Presents New Data at Digestive Disease Week

SAN DIEGO, May 21/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

Source: Movetis

For further information contact Axon Communications: Vicki Martin, Tel: +44-208-439-9407, vmartin@axon-com.com; Sarah Griffin, Tel: +44-208-439-9582, sgriffin@axon-com.com

2008-05-21 18:41:47 0368302 PRNEWSWIRE