MEDIPOST announced on December 5 that premature baby developmental chronic pulmonary disease preventative treatment ‘PNEUMOSTEM^®’ being developed has been designate ‘Orphan Drug’ by US FDA.

‘PNEUMOSTEM^®’ is preventative treatment for bronchial pulmonary dysplasia which is a main cause of death and complications in premature babies, and is made from mesenchymal stem cells extracted from cord blood (blood from umbilical cord).

With the designation of ‘PNEUMOSTEM^®’ as Orphan Drug, MEDIPOST will be processed through the Fast Track for its US clinical studies, tax and permit cost will be exemted up to 50%, and it is guaranteed exclusive sales right for 7 years after authorization to sell regardless of registration of patent.

MEDIPOST is planning to apply to FDA for approval of Phase 1’a clinical study of ‘PNEUMOSTEM^®’ in the latter half of 2014.

As ‘PNEUMOSTEM^®’ was designated Orphan Drug in US, MEDIPOST is anticipating positive effect on clinical studies and permit in Europe, Central America and Asian countries also.

‘PNEUMOSTEM^®’ was designated Orphan Drug, having been assessed as having high potential to succeed as new medicine because of the lack of existing treatment medicine for premature baby bronchial pulmonary dysplasia, completion of Phase 1 clinical study in Korea, and partly proving safety and potential treatment efficacy.