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Oxford BioMedica, a U.K. partner of the Foundation Fighting Blindness, has received orphan drug designation from the European Medicines Agency (EMEA) for their emerging Usher syndrome gene therapy known as UshStat. The orphan designation provides Oxford BioMedica with benefits and incentives including 10 years of marketing exclusivity, reduced regulatory fees, and clinical development guidance for UshStat. John Dawson, chief executive officer of Oxford BioMedica says that the designation is an important step in moving UshStat into a clinical trial for Usher syndrome type 1B. The company is planning to launch a clinical trial for UshStat in 2011. Oxford BioMedica’s StarGen gene therapy for Stargardt disease received an orphan designation from the EMEA in December 2009. A clinical trial for StarGen is planned for late 2010. The EMEA designates orphan status for treatments of life-threatening or chronically debilitating conditions that affect 5 in 10,000 people or fewer. The EMEA is the European Union’s regulatory agency for medicinal products. It functions similarly to the FDA in the U.S. |
