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SME Specific MeasuresQuality of Life and Management of Living Resources

Exploratory Award

Proposal number EXAW-1999-01168

AcronymEDOD

Proposal titleEuropean Development of Orphan Drugs

AbstractOrphan 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 manufacturedlocally with regulatory status EDOD (European

Development of Orphan Drugs) program intends tobring to the market orphan drugs with

high medical need which have been forsaken by US firms. Thesedrugs will be selected

among products currently locally produced by Hospital Pharmacies and which fallwithin

one the following therapeutic areas : clinical toxicology (antidotes), metabolic diseases or

onco-haematology. EDOD aims at upgrading pharmaceutical and medical quality of these

medications, and atharmonising at the european level access to these drugs by patients

suffering from rare diseases. EDODwill 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 onorphan drugs.

Key ActionQOL-GEN.  Generic activities

Start date6/07/2000End date6/07/2001

Intended Step 2 projectCooperative Research (CRAFT)Duration Exploratory Phase8 months

SME CoordinatorDR. Gilles ALBERICICompany sizeS2

OPI ORPHAN PHARMA INTERNATIONAL

5 allée de la croix des Roux

69126 - BRINDAS

France

Phone: 33682555142

Fax: 33478879937

Email: alberici@orphan-opi.com     alberici@compuserve.com

Internet: www.orphan-opi.com

SME Proposer(s)

OMICRON-PHARMAAustriaS2

Last update18/6/2001

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