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European development of orphan drugs

Objective

Orphan diseases are defined as disabling or life-threatening diseases, which incidence is below 5 p.10,000people. Some orphan drugs have been developed, mostly in the USA, thanks to the Orphan Drug Act. However, many of them have forsaken because of their low profitability and are still manufactured locally with regulatory status EDOD (European Development of Orphan Drugs) program intends to bring to the market orphan drugs with high medical need which have been forsaken by US firms. These drugs will be selected among products currently locally produced by Hospital Pharmacies and which fall within one the following therapeutic areas: clinical toxicology (antidotes), metabolic diseases or on co-haematology. EDOD aims at upgrading pharmaceutical and medical quality of these medications, and at harmonising at the European level access to these drugs by patients suffering from rare diseases. EDOD will bring together skills from 6 to 8 European SME's, so as to prepare European regulatory filing of 1 to2 drug candidates within 2 years. This will be the start of a longer co-operation between SME's on orphan drugs.

Funding Scheme

EAW - Exploratory awards

Coordinator

OPI - ORPHAN PHARMA INTERNATIONAL
Address
5 Allée De La Croix Des Roux
69126 Vaulx En Velin
France

Participants (1)

OMICRON PHARMA
Austria
Address
Kaiserstrasse 43
1070 Wien