- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
EMA grants Orphan Drug Designation for Debio 1143
8 December 2015 • Author: Victoria White
The European Medicines Agency (EMA) has granted Orphan Drug Designation to Debiopharm International‘s Debio 1143 for treatment of ovarian cancer.
Ovarian cancer affects around 154 000 people in the European Union (EU).
Orphan Drug Designation by the EMA provides regulatory and financial incentives to develop therapies for life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in EU, and for which no satisfactory treatment is available.
Debio1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radiosensitiser in oncology. The therapy demonstrated encouraging signs of efficacy and a favourable safety profile in clinical phase I trials.
Debiopharm plans to expand clinical development of Debio 1143
Further to the Phase I trial results and supported by this significant regulatory milestone, Debiopharm has said it will expand the clinical development of this therapy to patients with ovarian cancer.
“Obtaining orphan designation for Debio 1143 in the European Union is an important regulatory milestone,” stated Peggy Lipp, Director, Regulatory Affairs, Business Intelligence & Market Access, Debiopharm International S.A. “It speaks to the need for new treatment options in this chronically debilitating and life threatening condition and the potential role of Debio 1143’s mode of action. This orphan drug designation is a proof of our commitment to developing innovative therapies for oncology patients.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics