KAI Pharmaceuticals has entered into an agreement with Ono Pharmaceutical for the development and commercialisation of KAI-4169 in Japan.
KAI-4169, an intravenous formulation for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease-mineral and bone disorder is currently in Phase II clinical testing.
Ono will receives exclusive rights to all indications for injectable formulations of KAI-4169 in Japan, while KAI retains marketing rights in all other regions of the world.
KAI will receive about 1bn yen ($13m) in an upfront payment from Ono.
KAI president and CEO Steven James said that the company anticipates completing the Phase II trial and reporting top-line data by the end of this year.
PhaseI1 data demonstrated that single intravenous doses of KAI-4169 were safe and well-tolerated, and resulted in sustained reductions in serum levels of parathyroid hormone in both healthy male subjects and end-stage renal disease patients with secondary hyperparathyroidism.