Compounds in clinical development

4 compounds in Clinical Development

Compound one, RESOLOR (prucalopride), is a true "enterokinetic" that acts primarily on lower GI motility and is indicated for the treatment of severe forms of chronic constipation

RESOLOR is a novel, innovative enterokinetic compound that restores the natural movement of the bowels
It has proven in 3 phase III trials to be a truly effective treatment that offers significant and meaningful benefits to patients especially in patients not satisfied or eligible for treatment with laxatives
RESOLOR is well tolerated in all patient groups studied to date, including the elderly and children. The majority of side effects are mild to moderate and transient. The most frequent side effects are headache, nausea and diarrhoea
RESOLOR has a favorable benefit/risk profile compared to laxatives or other 5 HT4 agonists
RESOLOR provides clear Quality of Life improvement and economic benefits to patients
We will generate the required amount of drug stability data and establish - in close consultation with the Health Authorities - the most appropriate strategy for the RESOLOR filing
The Potential for RESOLOR is significant with more than 11 million patients suffering from chronic constipation in Europe and 25 million worldwide

Compound two, M0002, is in phase IIa and is indicated for treatment of ascites (an accumulation of fluid caused by liver malfunction in patients with cirrhosis or hepatitis C)

M0002 is a Vasopressin 2 antagonist and represents a new class of compounds – aquaretics – that produce profound diuresis without loss of electrolytes
M0002 will be of major benefit to those patients not responding satisfactorily to diuretics alone
M0002 has already demonstrated a dose-dependent effect, measured by urinary output, in a single-dose pilot trial in a cirrhotic patients with ascites
M0002 will address a high unmet medical need: 3.3 million patients suffering from ascites worldwide

The “next-generation gastrokinetics” development program, has two lead products: M0003 and M0004. Primary development will focus on two indications with a clear unmet medical need: pediatric reflux and diabetic gastroparesis

this program capitalises on more than 20 years of motility research conducted at Janssen Pharmaceutica and represents the promise of next-generation GI gastrokinetic compounds
M0003 (ready to enter phase II) and M0004 (ready to enter phase I) act on the motility of the upper GI tract
an estimated 800,000 children suffer from severe paediatric reflux (regurgitation) primarily caused by impaired motility that require drug treatment. The European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines position gastrokinetics as the standard of care for this population
Gastroparesis (slow emptying of the stomach) is a condition affecting more than 6 million people with little or no treatment alternatives available. It is a frequent problem in diabetes patients (estimated to affect 4 million diabetics) and those suffering from diseases such as Parkinson’s or pancreatitis