Company gains worldwide rights excluding Japan to a Phase II drug for secondary hyperparathyroidism.
Amgen will pay $315 million in cash to take over KAI Pharmaceuticals. The company has one drug candidate in development, a peptide product called KAI-4169. It is being studied for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are on dialysis.
Through this acquisition, Amgen will acquire worldwide rights excluding Japan to KAI-4169. KAI signed over Japanese rights covering the drug to Ono Pharmaceutical in September 2011. In addition to SHPT, KAI is conducting preclinical research on prehemodialysis applications of KAI-4169.
In connection with Amgen’s purchase of KAI, Amgen has provided a loan to enable Phase III development planning for KAI-4169 prior to closing. The peptide candidate is currently in its second Phase II study in CKD patients on dialysis.
KAI-4169 is a novel peptide agonist of the calcium sensing receptor (CaSR), which affects calcium homeostasis by modulating the release of parathyroid hormone (PTH). It is administered intravenously at the same time the patient is undergoing dialysis.
Phase IIa data demonstrated that KAI-4169 resulted in sustained reductions in PTH, phosphorus, calcium, and FGF-23, which are all recognized markers of SHPT. The data also showed that KAI-4169 was well-tolerated; adverse events occurring in two or more subjects included nausea, headache, anxiety, and vomiting. No subjects discontinued use due to adverse events, and the incidence of gastrointestinal adverse events was similar in the KAI-4169 and placebo treatment groups.
“KAI has demonstrated encouraging results in the clinic,” says Sean E. Harper, M.D., evp of R&D at Amgen. “We are excited about acquiring KAI as well as the opportunity to potentially deliver a novel therapy for chronic kidney disease patients on dialysis suffering from secondary hyperparathyroidism.”
Steve James, president and CEO of KAI, adds, “Amgen is ideally positioned to bring KAI-4169 to market and to patients given the company’s decades of experience in developing and delivering therapies for patients with chronic kidney disease.”
The transaction has been approved by the stockholders of KAI and approved by the board of directors of each company. Once completed KAI will become a wholly owned subsidiary of Amgen.
