Lausanne, Switzerland, January 10, 2001 – The Swiss-based pharmaceutical development company Debiopharm today announced a further success in its history of development of new chemical entities for therapeutic use. The results of a multi-center Phase III study carried out using the compound vapreotide, a somatostatin analog, for early treatment of cirrhosis-related variceal bleeding, have been published in the January 4, 2001, issue of the New England Journal of Medicine. The study shows that the infusion of vapreotide, started as soon as an upper digestive tract bleeding is suspected in a cirrhotic patient and maintained for five days, results in a significant improvement of haemostasis. In addition, the general condition of the vapreotide treated patients remained significantly improved during the five weeks following infusion discontinuation. The work, carried out by a team of investigators led by Prof. P. Calès, from the University Hospital of Angers, France, reinforces Debiopharm’s role as a leading European drug developer.
“The vapreotide study is an excellent demonstration of the capabilities that Debiopharm can offer to research institutions, the pharmaceutical and biotech industry,” says Dr. R.-Y. Mauvernay, founder and President of the Debio Group. “After licensing-in compounds, we develop them according to the stringent regulatory requirements up to reaching marketing authorization. Our wide network of top clinicians and researchers, our wholly-owned contract research organization Debioclinic and our regulatory expertise, enable us to manage comprehensive, timely studies for successful registration. The vapreotide study is an example of the excellence Debiopharm can provide through this network.”
Debiopharm has a successful track record in bringing new chemical entities to the market in Europe and the United States. In particular, Debiopharm has developed triptorelin, a luteinizing hormone – releasing hormone (LH-RH) agonist, which is currently approved and commercialized in over 80 countries for the treatment of prostate cancer, endometriosis and precocious puberty. Similarly, Debiopharm has successfully developed oxaliplatin, the first diamine-cyclohexane platinum complex and a third generation platinum series, presently registered and commercialized in major European countries, Latin America and Asia for the treatment of advanced colorectal cancer.
Specialized in oncology, hormonal and niche products for serious medical conditions, Debiopharm is the preferred partner of research institutions, pharmaceutical and biotech companies who seek to successfully develop their drug. Debio Recherche Pharmaceutique (Debio R.P.), Debiopharm’s sister company, is a leading world player in the research, development and manufacturing of polymer-based controlled-release injectable formulations for peptides and proteins, including proprietary technologies suitable for other therapeutic modalities such as soluble polymer drug conjugates for parenteral administration. Debio R.P. carries out industrial scale up under current good manufacturing practice (cGMP) and is FDA inspected.