Milestone in the treatment of severe burns
The An orphan drug designation (EU/3/22/2637) relates to the use of human allogeneic keratinocytes for the treatment of severe burns.These skin cells, specially preserved using a patented process, are the active component of the product EVOCellicwhich is currently undergoing preclinical development by EVOMEDIS in collaboration with researchers and physicians from COREMEDthe Medical University of Graz and the LMU Munich (Ludwig-Maximilians-Universität München) and the TERM Würzburg (Chair of Tissue Engineering and Regenerative Medicine).
Dr. Martin Funk is the team leader and CEO of EVOMEDIS, which is based in the new ZWT ACCELERATOR (ZWT - Centre for Knowledge and Technology Transfer).
"The orphan drug designation is an important milestone for us and sends a strong signal to the outside world. It enables the EMA to grant discounts on scientific/regulatory advice and other regulatory fees during the development of EVOCellic even before authorisation."
Prof. Lars Kamolz is Institute Director of COREMED, Centre for Regenerative Medicine and Precision Medicine and Director of the University Clinic for Surgery Graz:
"Such projects and developments can only be realised through networked research and close cooperation between the various partners. We are delighted to have been involved in this great project right from the start."
An orphan drug designation
The advantages of an orphan drug designation are an accelerated authorisation procedure and market exclusivity in Europe for 10 years from authorisation, and in the USA for 7 years if the US Food and Drug Administration (FDA) also grants an orphan drug designation. An orphan drug designation thus supports the development of drugs for people suffering from rare, life-threatening diseases. Diseases that are often neglected by biomedical research and development due to their rarity are referred to as orphan diseases, i.e. diseases that nobody cares about. A so-called orphan drug designation is granted to a medical substance by the European and American drug authorities, EMA and FDA, if it can be used to treat one of these particularly rare diseases. If an orphan drug designation is to be granted, the drug authorities examine not only the actual rarity of the disease but also whether the developer of the drug can provide initial evidence of possible efficacy.
