Amgen (AMGN) recently announced its intention to acquire privately-held KAI Pharmaceuticals. With this acquisition, Amgen will gain global rights (excluding Japan) to KAI Pharmaceuticals’ lead pipeline candidate, KAI-4169.
Terms of the Agreement
Amgen will make a cash payment of $315 million for the acquisition. The company has already loaned an undisclosed amount to support KAI Pharmaceuticals’ phase III development plans for KAI-4169.
KAI-4169
KAI-4169, the lead candidate at KAI Pharmaceuticals, is being evaluated for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on dialysis. SHPT is a common and serious complication for the above patient population.
KAI Pharmaceuticals has already presented encouraging phase IIa data on the candidate. Patients in the KAI-4169 arm experienced a sustained reduction in parathyroid hormone (PTH), phosphorus, calcium and FGF-23.
KAI-4169 was found to be well tolerated with adverse events including nausea, headache, anxiety and vomiting. While there were no discontinuations due to adverse events, the incidence of gastrointestinal adverse events was similar in both the KAI-4169 and placebo arms.
KAI-4169 is currently in a second phase II study which is being conducted in CKD patients on dialysis.
KAI Pharmaceuticals has a partnership with Ono Pharmaceutical Co., Ltd. for the development and commercialization of KAI-4169 in Japan. KAI Pharmaceuticals is also evaluating the use of KAI-4169 in pre-hemodialysis applications.
Our Take
We note that Amgen already has a presence in the CKD market in the form of Sensipar (EU trade name: Mimpara). Sensipar, approved for the treatment of CKD patients on dialysis who suffer from SHPT, posted sales of $808 million in 2011.
By developing KAI-4169, Amgen is most likely looking to maintain its share in this market once Sensipar loses patent protection. KAI-4169 could represent a different and convenient treatment option for patients as it is being developed as an intravenous (IV) formulation that will be administered at the time of dialysis while Sensipar is a tablet. However, KAI-4169 is yet to enter phase III development and is still a few years from commercialization.
This is the second major deal announced by Amgen already this month. Earlier, the company entered into a collaboration agreement with AstraZeneca (AZN) for the joint development and commercialization of five monoclonal antibodies in Amgen’s pipeline. Meanwhile, earlier this year, Amgen acquired biotech company, Micromet, Inc.
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