COPENHAGEN, August 1 /PRNewswire/ -- Following a meeting in the COMP Committee, the EMEA, the European health authorities, have recommended that ASF-1096 be granted orphan drug status for the treatment of "Cutaneous Lupus Erythematosus". Orphan drug status is granted to drug candidates that are developed for severe, disabling diseases for which there are currently no satisfactory products on the market. Moreover, a condition for granting orphan drug status is that the disease is rare and exists in less than five out of 10,000 citizens in the EU.
Cutaneous Lupus Erythematosus (CLE) is a chronic and severe skin disease that shows by way of severe, inflamed lesions in the skin. These lesions may be active for several months or years and in some cases leave significant scarring and/or pigmentary changes and permanent hair loss. CLE is currently mainly treated with strong steroids, possibly in combination with anti-malaria products, but many patients cannot be treated sufficiently, do not achieve a satisfactory effect or suffer substantial adverse side effects from the treatment.
Orphan drug status for ASF-1096 may involve major benefits to Astion:
- Reduced costs in connection with EMEA filings
- Easier and cheaper access to regulatory assistance in connection with the future development progress
- Ten-year market exclusivity to Astion Pharma
- Opportunity of faster and more flexible processing of application for marketing approval.
"With the orphan drug status we have taken an important step towards bringing ASF-1096 into an optimal development process towards commercialisation", said Lars Smedegaard Andersen, CEO.
ASF-1096 is in clinical Phase II, and Astion Pharma expects to bring the drug candidate into Phase III within 6-12 months. Astion Pharma expects to file an application for orphan drug status with the US authorities (FDA) in August 2007.
Astion Pharma A/S develops pharmaceutical products for the treatment of skin diseases. It is estimated that one person in four worldwide will suffer from a skin diseases sometime in life, causing a deterioration of their quality of life. It is the Company's goal to become a leading player in the treatment of skin diseases for which there is currently a major need for new and better therapies. Astion Pharma has a strong platform of proprietary technologies for the development of new and innovative products. The Company pursues development activities through a strong international network of scientific partners and leading contract research organisations. The Company currently has three development projects in Phase II clinical studies in seborrheic dermatitis, itching and cutaneous lupus in addition to a large portfolio of product candidates and research projects in earlier phases. For additional information please visit our web site: http://www.astion.com.
Astion Pharma A/S