Ibio acquires Orphan Drug Designation and Fabry disease therapeutic program from Kentucky

Feb 23 2011

iBio, Inc. (NYSE AMEX:IBIO) today announced it has acquired Orphan Drug Designation for plant-produced human alpha galactosidase A ("α-Gal A") and related property rights from an affiliate of Kentucky Bioprocessing LLC ("KBP") and has initiated a program, based on its iBioLaunch™ platform, to develop an improved version of the enzyme for therapy of Fabry disease. iBio will work with its regular research and development collaborator, Fraunhofer USA Center for Molecular Biotechnology, for product development, and with KBP for manufacture of clinical and commercial quantities of the new product for iBio or its licensees.

This Fabry disease therapeutic program will be part of iBio's broader program to bring forward approximately ten more candidate proteins for commercialization as "biosimilar" or "biobetter" therapeutic products. iBio intends to advance these candidates to a point sufficient to demonstrate the advantages of making them using the iBioLaunch platform technology and then license them to industry partners. iBio already has demonstrated the applicability of its platform technology to most therapeutic protein classes, ranging from cytokines and growth factors to enzymes and antibodies.

Under its current program, iBio is selecting commercial targets that exemplify advantages of the iBioLaunch technology and meet apparent market needs. Selection of the Fabry disease candidate was influenced by: the current worldwide shortage of α-Gal A for enzyme replacement therapy for Fabry disease; the likelihood that the disease is significantly under-diagnosed; the opportunity to acquire Orphan Drug Designation for plant-produced α-Gal A (which can provide significant market protection and tax advantages); and iBio's belief this will further demonstrate some of the advantages of our technology such as scalability for Orphan Drug applications, more rapid product development, and improved efficacy compared to other systems.

"We believe the unusual scalability, speed and efficiency of iBio's plant-based protein expression platform technology can make important contributions to rapid development and availability of therapies against orphan diseases such as Fabry Disease," said Robert Erwin, President of iBio.

Current estimates indicate a patient population affected by Fabry Disease of approximately 8,000 to 10,000. Current therapies are estimated to cost more than $200,000 per patient year. Symptoms usually begin in childhood. Unless continuously treated, Fabry Disease results in many severe health problems such as kidney failure, heart damage and cerebrovascular problems.