Apoxis receives FDA Orphan Medicinal Product designation for treatment of XLHED

06-Feb-2006

Apoxis SA announced it has received Orphan Medicinal Product designation from the FDA for its rare disease protein therapeutic, APO200. Apoxis had already received orphan designation for APO200 from the EMEA in November 2005. Orphan Medicinal Product Designation affords a number of incentives including access to free scientific advice and protocol assistance (in the EU), reduced regulatory fees, plus seven years market exclusivity after the grant of a marketing authorisation in the USA and ten years of market exclusivity in Europe.

APO200 is a protein therapeutic based on Apoxis' multimerization technology and is currently in preclinical development. XLHED (X-linked hypohidrotic ectodermal dysplasia) is a rare genetic and potentially life threatening disease. Patients affected by the disease cannot control their body temperature through sweating, and sudden infant death in relation to hyperthermia has been reported. Infants also frequently suffer from respiratory tract infections, due to the absence of mucous glands in the respiratory tract, and these can result in sudden death. Other symptoms include a lack of normal hair, and abnormal development of mouth and teeth. APO200 is expected to enter human studies in 2007 following further preclinical studies.

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