) recently completed its acquisition of privately held pharma
company, KAI Pharmaceuticals. With this acquisition, which was
first announced in April 2012, Amgen has gained global rights
(excluding Japan) to KAI-4169.
At the time of announcing the deal, Amgen had said that it would
make a cash payment of $315 million and loan an undisclosed amount
to support KAI Pharmaceuticals' phase III development plans for
KAI-4169 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 Pharmaceuticals has a partnership with Ono Pharmaceutical
Co., Ltd. for the development and commercialization of KAI-4169 in
Japan. KAI-4169 may also have the potential to be used in
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
Amgen has been pretty active on the deal making front. Major
deals include a collaboration agreement with
) for the joint development and commercialization of five
monoclonal antibodies in Amgen's pipeline and the acquisition of
biotech company, Micromet, Inc.
We currently have a Neutral recommendation on Amgen, which
carries a Zacks #3 Rank (short-term 'Hold' rating).
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