contains recombinant human parathyroid hormone (1-34) which has an identical sequence of first 34 N-Terminal amino acids (the biological active region) of 84 amino acid human parathyroid hormone. It is produced in E. coli using recombinant DNA technology.
rhPTH (1-34) has the same affinity as parathyroid hormone and produces same physiological effects via regulating Calcium and Phosphate metabolism in Bone and Kidney.
It binds to the PTH receptors, which then increases the number of osteoblasts, stimulating the production of new trabecular and cortical bone formation.
Post Menopausal Women with Osteoporosis who are at high risk for fracture. Also for increase in bone mass of men with primary or hypogonadal osteoporosis who are at high risk for fracture.
rhPTH (1-34) has completed Clinical Trial Phase 3. Presently, preparing for NDA submission before the end of 2010.
Target product launch date is by fourth quarter of 2012.