) announced that AMG 416 has met the primary as well as secondary
endpoints in the second phase III registration study evaluating the
candidate for the treatment of secondary hyperparathyroidism in
patients with chronic kidney disease (CKD), receiving hemodialysis.
We expect investors to react positively to the news.
Data from the 26-week, randomized, double-blind, placebo-controlled
study revealed that a statistically significant number of patients
on AMG 416 achieved greater than 30% reduction in parathyroid
hormone levels compared to patients on placebo (74% versus 8.3%).
In Jul 2014, the company had announced positive data from another
phase III study evaluating the efficacy and safety of AMG 416 in
CKD patients receiving hemodialysis and suffering from secondary
hyperparathyroidism. The study met all its primary and secondary
Amgen is also conducting a head-to-head study evaluating AMG 416 in
comparison with Sensipar (cinacalcet). Results should be out in
2015. We remind investors that the acquisition of KAI
Pharmaceuticals, Inc. in Jul 2012 added AMG 416 to Amgen's
Secondary hyperparathyroidism is often progressive in patients
suffering from CKD. According to the press release issued by Amgen,
secondary hyperparathyroidism affects a large number of the
approximately two million dialysis-dependent patients worldwide.
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in
the biotech sector include Gilead Sciences Inc. (
), Alexion Pharmaceuticals, Inc. (
) and Medivation, Inc. (
). While Gilead carries a Zacks Rank #1 (Strong Buy), Alexion and
Medivation are Zacks Rank #2 (Buy) stocks.
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