iBio, Inc. (IBIO) Achieves First Milestone in Collaboration with AzarGen Biotechnologies

September 29, 2016 8:39 AM EDT
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iBio, Inc. (NYSE: IBIO) announced the successful application of its proprietary technologies to achieve the first milestone in its commercial development agreement with AzarGen Biotechnologies (Pty) Ltd (AzarGen) of South Africa for the development and manufacture of an improved surfactant protein for the treatment of neonatal respiratory distress syndrome (RDS).

The application of iBio technology to AzarGen's human surfactant protein (based on rh-SPB) in iBio CMO LLC's development and manufacturing facility in Bryan, Texas enabled AzarGen to obtain the pilot scale quantities and purity of a recombinant human surfactant protein needed to complete its first commercial development milestone in the development of its novel treatment for RDS. The next phase of the agreement between the companies focuses on further refinement and documentation of potential advantages of AzarGen's plant-made surfactant product over currently marketed products, including enhanced efficacy, safety, increased production speed, reduced production costs, and more efficient process scalability.

"We focus on addressing the consequences of preterm birth with special emphasis on surfactant replacement therapy in low-income countries. This successful milestone result has set the pace for scale-up production and elevated the sense of urgency for pre-clinical development," said Dr. Mauritz Venter, CEO of AzarGen. "We are supported by an experienced team of advisors at AzarGen and iBio. We expect that our product will be clinically superior to current animal-derived and synthetic peptide surfactants. We believe collaboration with iBio, will advance AzarGen's product development significantly."

RDS occurs in infants whose lungs have not fully developed and therefore often produce inadequate natural lung surfactant, a substance which helps with lung inflation and oxygen transfer. The disease is a complication of approximately 1% of pregnancies and according to Medscape is estimated to occur in 20,000 to 30,000 newborn infants each year in the U.S. By extrapolation, Cure.com estimates that there are approximately 6,500 cases each year in South Africa and up to 50,000 cases each year in the African continent.

"We are pleased to apply our technology and experience to advance AzarGen's important human surfactant protein product into practical use," said Dr. Barry Holtz, iBio CMO's president. "Making this type of therapeutic product is a difficult challenge but very much within iBio's expertise. We expect steady progress in the next phase of development and look forward to assisting South Africa's first plant-made pharmaceutical company achieve product success."

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