KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced the signing of an agreement with Ono Pharmaceutical Co., Ltd. for the development and commercialization in Japan of KAI-4169, KAI’s lead product candidate. KAI-4169 is a novel therapeutic agent in phase 2 clinical testing as an intravenous (IV) formulation for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease-mineral and bone disorder (CKD-MBD). Under the terms of the agreement, Ono receives exclusive rights to all indications for injectable formulations of KAI-4169 in Japan; KAI retains commercialization rights in all other regions of the world.

KAI will receive approximately $13 million (JPY 1 billion) in an upfront payment from Ono, as well as significant development, regulatory and commercialization milestones. KAI also will receive a royalty on sales. Additional financial terms of the agreement were not disclosed.

Steven James, president and CEO of KAI, commented, “This partnership with Ono is a critical event for the KAI-4169 programme, allying us with a partner that has a strong track record advancing innovative pharmaceutical products. We are excited about the continued momentum of the KAI-4169 program, and we anticipate completing the phase 2 trial and reporting top-line data by the end of this year.”

“Ono’s research and development principle is to develop and deliver drugs that truly benefit patients and society. We put this into practice by tackling diseases that remain unconquered and addressing high unmet healthcare needs where patient satisfaction with current treatments is low. We believe KAI-4169 has the potential to satisfy these unmet needs and, therefore, fits Ono’s strategy very well. For example, a key differentiating advantage of KAI-4169 is that it is an IV formulation that is designed to improve drug adherence. We plan to develop KAI-4169 expeditiously in Japan,” said Gyo Sagara, Ono’s president, representative director and CEO.

Phase 1 data have demonstrated that single IV 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 (ESRD) patients with secondary hyperparathyroidism. Clinical data from the KAI-4169 programme were presented recently at the Endocrine Society's 93rd Annual Meeting.

In the US, there are roughly 600,000 and eight million patients with Stage 5 and Stage 3/4 CKD, respectively. Bone disease often develops early in CKD and worsens as renal function declines and the disease progresses. Most ESRD patients on dialysis are affected by CKD-MBD, which can lead to significant morbidity and mortality, including bone pain and fractures, vascular calcification and cardiovascular events.

KAI is a clinical-stage, biopharmaceutical company with a lead product candidate, KAI-4169, in development for the treatment of SHPT in patients with CKD-MBD. Building on promising, early-stage clinical data, KAI has advanced KAI-4169 into a phase 2 clinical study in ESRD patients on dialysis, which is expected to complete in the second half of 2011.