Turnhout, Belgium (ots/PRNewswire) - Movetis today announced
that the European Medicines Agency (EMeA) has accepted the Marketing
Authorization Application (MAA) submission for RESOLOR(R)
(prucalopride) as a treatment for chronic constipation in adults in
whom laxatives fail to provide adequate relief.
RESOLOR is a new selective, high affinity 5-HT4 receptor agonist,
which has the potential to improve the symptoms of people with
abnormalities in gastrointestinal (GI) motility by restoring the
smooth functioning of the lower GI tract.
Chronic constipation affects more than 80 million people
worldwide (1), of which 37 million live in the European Union, and
poses a significant burden for those it affects. In Europe, many
patients frequently visit their doctors with complaints of chronic
constipation after dissatisfactory results with over-the-counter
medication, primarily because of a lack of efficacy.
The application for marketing authorization is supported by an
extensive clinical development programme consisting of three
identical Phase III studies and by data derived from a comprehensive
clinical trial programme including an additional 79 studies, which
fully explored the clinical profile of RESOLOR for a variety of
medical needs and patient populations. The studies also offer a
robust and in depth evaluation of safety, pharmacokinetics, potential
for drug interactions, bioequivalence and pharmacodynamics.Total
RESOLOR exposure in the programme exceeds 3000 patients and 2,500
"The RESOLOR filing is a major milestone for Movetis and
demonstrates our commitment to providing an effective treatment for
patients with chronic constipation," said Dirk Reyn, CEO of Movetis.
"Despite the millions of patients worldwide who visit their doctors
seeking help after unsatisfactory results with over-the-counter
medicines, chronic constipation remains overlooked and the impact of
the condition underestimated. We look forward to working with the
Regulators as we progress through the registration process."
Studies submitted in the filing
The three pivotal studies were randomised, parallel-group and
placebo-controlled, with a run-in period of two weeks and a treatment
period of 12 weeks. The primary efficacy endpoint in these studies
was the proportion of patients with a mean of three or more
spontaneous complete bowel movements (SCBMs) per week over the 12
weeks of the study. A bowel movement was defined as spontaneous if no
laxatives were taken in the 24 hours preceding the bowel movement.
This is in line with the EMEA Scientific Advice that was obtained,
and from a clinical perspective would be considered to equate to
normalisation of bowel movements.
The RESOLOR studies also assessed a wide range of secondary
endpoints covering bowel movements, symptoms and disease-related
quality of life, including overall satisfaction with treatment.
RESOLOR is a novel enterokinetic treatment for chronic
constipation in a patient population not adequately relieved by
laxative treatments. It is a 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. The Marketing Authorization
Application was submitted with EMeA in April 2008.
About chronic constipation
Chronic constipation is a disorder of the gastrointestinal tract.
It is a prevalent and debilitating condition that is not always well
understood and is in many cases inadequately treated. The 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(2). In Europe, an estimated 10
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).
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, paediatric reflux in
infants, diabetic gastroparesis, non erosive and refractory reflux
disease, post-infectious IBS and secretory diarrhoea. In addition,
Movetis owns a large library of qualified lead compounds for further
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 chronic
constipation currently under review for Marketing Authorisation in
- 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 paediatric
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
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 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). Reyn D. Opportunities in Gastroenterology. Drug Discovery
World Winter 2007/8.
(2). Drossman A (2006) Rome III: The new criteria. Chinese
Journal of Digestive Diseases 7 (4) , 181-185.
(3). IMS Health.
(4). Higgins PD, Johanson JF. Epidemiology of constipation in
North America: a systematic review. Am J Gastroenterol 2004;99:750-9.
ots Originaltext: Movetis NV
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