Evomedis GmbH. (5/12/23). "Press Release: European Commission Grants Orphan Drug Designation for EVOCellic".

	Region	EU (European Union)
	Organisation	Evomedis GmbH
	Organisation 2	COREMED Graz (Cooperative Center for Regenerative Medicine / Jpanneum Research Forschungsgesellschaft mbH)
	Group	Joanneum Research (Group)
	Product	EVOCellic (keratinocyte-based tissue-engineered skin substitute made from allogeneic cells)
	Product 2	preclinical research
	Person	Funk, Martin (Evomedis 202311 CEO)

Important milestone: EVOMEDIS has received Orphan Drug Designation from the European Medicines Agency (EMA) for its novel cell therapy drug for the treatment of severe burns.

Specifically, the Orphan Drug Designation (EU/3/22/2637) refers to the use of human allogeneic keratinocytes, for the treatment of partial deep dermal and full thickness burns. These skin cells, specially produced by a patented process, are the active component of the product EVOCellic, which is currently in preclinical development.

EVOMEDIS team leader and CEO, Dr. Martin Funk, who developed EVOCellic in collaboration with researchers and physicians from COREMED (Center for Regenerative Medicine and Precision Medicine of JOANNEUM RESEARCH), the Med Uni Graz, as well as LMU Munich, and TERM Würzburg, explains: "The Orphan Drug Designation is an important milestone for us and a strong signal to the outside world. It enables the EMA to grant us benefits for scientific/regulatory advice and regulatory fees even during the development of EVOCellic prior to approval. The development of such a product is only possible through close cooperation with national and international partners and at a place where such a cooperation is fostered like at the new ZWT ACCELERATOR at the Medical Science City Graz “

Prof. Lars Kamolz, Institute Director of COREMED and Director of the University Hospital for Surgery Graz, says: "Such projects and developments can only be implemented through integrated research and close cooperation between the different partners. We are pleased to be involved in this great project from the very beginning."

Orphan Drug Designation

The advantages of an Orphan Drug Designation are an accelerated approval process and market exclusivity in Europe for 10 years from the date of approval. The process thus supports the development of drugs for people suffering from rare, life-threatening diseases, that are often neglected by the biomedical research & development because of their rarity. The Orphan Drug Designation is granted to a medical substance by the EMA and FDA, if one of these particularly rare diseases (affects less than 1 in 2,000 citizen) can be treated with this drug. If an Orphan Drug Designation is to be granted, drug authorities check not only the actual rarity of the disease, but also whether the developer of the drug can provide initial indications of possible efficacy.

Record changed: 2024-01-20

Picture Swiss Biotech Association Global Village 2025 SBD25 Basel 650x200px

More documents for Evomedis GmbH

[1] Evomedis GmbH. (11/23/23). "Press Release: Evomedis Announces Strategic Partnership with Medical University of Graz and COREMED Graz to Foster Wound Healing Innovation". Graz....

To subscribe to our free, monthly newsletter for the European life sciences, please send an e-mail to [email protected] and simply fill the subject line with the word »LSE Newsletter«

Find more infos about advertising at [iito] web portals in our media flyer [iito] in a Nutshell [PDF file]

Please visit also our web portals for the European life sciences and the worldwide mass spectrometry industry at Life-Sciences-Europe.com (European life sciences) and Mass-Spec-Capital.com (worldwide mass spectrometry)

Please visit also our web portals for the life sciences in German-speaking Europe (DE, AT & CH) and the worldwide mass spectrometry industry at Life-Sciences-Germany.com (life sciences in German-speaking Europe) and Mass-Spec-Capital.com (worldwide mass spectrometry)