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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Wednesday, June 20, 2012

Medgenics Receives Orphan Drug Designation from FDA for INFRADURE Biopump to Treat Hepatitis D

May accelerate regulatory pathway for portfolio of Biopump indications

MISGAV, Israel & SAN FRANCISCO, Jun 20, 2012 (BUSINESS WIRE) -- Medgenics, Inc. (nyse mkt:MDGN and AIM)(nyse mkt:MEDG), the developer of Biopump(TM), a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that its INFRADURE(TM) Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D. INFRADURE is the version of Medgenics' Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan Drug Designation granted for treatment of a clinical indication using the Biopump. 

Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process. 

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