Repligen Receives Orphan Drug Designation from the FDA for RG2833 for Friedreich's Ataxia

WALTHAM, Mass., May 24 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor for the treatment of Friedreich's ataxia.  Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia.  This designation may also qualify Repligen to benefit from certain tax credits and a waiver of the company's obligation to pay the FDA application user fees for this product as required by the Prescription Drug User Fee Act. The U.S. Orphan Drug Act provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans.  There are approximately 15,000 people worldwide.......Read more

Iron Regulatory Proteins: From Molecular Mechanisms to Drug Development

Antioxidants & Redox Signaling. -Not available-, ahead of print. doi:10.1089/ars.2009.2983.

Stefania Recalcati,¹ Giorgio Minotti,² and Gaetano Cairo¹

¹Department of Human Morphology and Biomedical Sciences Città Studi, University of Milan, Milano, Italy.

²CIR and Drug Sciences, University Campus Bio-Medico and Fondazione Alberto Sordi-Research Institute on Aging, Roma, Italy.