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Avi BioPharma, Inc.
Orphan designation filed for SARS antisense drug
September 10th, 2003
Avi BioPharma, Inc., (AVII, AVIIW, AVIIZ) announced that, based on positive preclinical data, it has filed an application with the U.S. Food and Drug Administration (FDA) to obtain orphan designation for its Neugene antisense drug, Avi-4179, targeting the coronavirus implicated in severe acute respiratory syndrome (SARS). The FDA grants orphan designation to drugs developed for rare diseases, which are defined as having a prevalence of less than 200,000 cases annually. The SARS virus epidemic falls well within the parameters for orphan drug designation. The achievement of orphan designation provides for 7 years of marketing exclusivity, effectively preventing a similar...
Source: Biotech Week (2003-09-10)
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