The board of BioGaia (STO:BIOG-B) has decided to invest in the first phase of a long-term project aimed at developing a drug with rigorous hygiene, analysis and documentation requirements, to treat the highly fatal disease Necrotising Enterocolitis (NEC), which affects premature infants.
BioGaia will invest SEK 42 million in the project over a two-year period. The project will be driven by BioGaia's subsidiary Infant Bacterial Therapeutics (IBT), of which 9% is owned by the company's President, Staffan Strömberg, and its Research Director, Eamonn Connolly. The remaining 91% is owned by BioGaia.
IBT will develop a new formulation and a manufacturing process that are wholly adapted to the stringent quality requirements placed by the FDA (the U.S. Food and Drug Administration) for a biological drug and the product's area of use in neonatal intensive care units. The company's assessment is that around SEK 26 million of the total of SEK 42 million will be capitalised in IBT, which will result in costs of approximately SEK 8 million per year in 2014 and 2015. Should the drug development not be completed it is BioGaia's intention to market the formulation under a different product category.