MediWound has reported positive results from a pre planned interim analysis of a phase III trial for Debrase, an enzymatic debriding agent for burns. The company reported that the phase III study with Debrase for the treatment of burns met the two primary endpoints of the study: reduction in the percentage of wound surgically excised and reduction in the percentage of wound autografted with statistical significance.
Based on these results, and in agreement with the approved clinical study protocol and past communications with the European Medicines Agency (EMEA), MediWound revealed that the study is considered to have reached its objectives and that it is permitted to stop recruitment at this time. Following the completion of a full analysis of the study, MediWound expects to submit an application for marketing authorization in Europe during 2010.
Aharon Schwartz, vice president of Teva Innovative Ventures, said: “We are delighted with the successful results of MediWound. We look forward to bringing this new treatment option to markets around the world. MediWound is a prime example of how we broaden our innovative pipeline through licensing of promising products. Teva Innovative Ventures currently has about 20 portfolio companies. Our objective is to seek partnerships globally with companies and academic institutions with molecules in all stages of development to develop new speciality medicines and treatments.”
Reportedly, Debrase was granted orphan drug status in Europe and the United States, granting marketing exclusivity for 10 and 7 years, respectively. Teva Pharmaceutical Industries currently holds 11% of MediWound (on a fully diluted basis) and owns the marketing rights for Debrase in certain territories.