Rare Pediatric Disease Designation is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Having obtained the Rare Pediatric Disease Designation, FDA may award IBT a priority review voucher. A priority review voucher means that FDA ought to handle a drug application faster than normal.
Staffan Strömberg, Chief Executive Officer of IBT, commented, "The fact that FDA has given IBP-9414 Rare Pediatric Disease Designation, confirms how important it is to reach our goal that fewer premature babies shall be affected by the deadly disease necrotizing entercolitis, whilst at the same time this can reduce the time for this product to reach the market."
For additional information please contact
Staffan Strömberg, CEO, phone: +46 8 410 145 55
Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55
Infant Bacterial Therapeutics AB
Bryggargatan 10, 111 21 Stockholm
Phone: +46 8 410 145 55
Infant Bacterial Therapeutics AB ("IBT") is a pharmaceutical company based in Stockholm that develops drugs that meet the needs of the premature infant. IBT's current focus is on clinical development of IBP-9414, a drug candidate containing Lactobacillus reuteri, in the prevention of necrotizing enterocolitis ("NEC"), a fatal disease that affects premature infants. IBT is listed on NASDAQ First North.