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Amgen (AMGN) Reports Encouraging Top-Line Data on AMG 416

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Amgen Inc. (AMGN) 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 endpoints.

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 pipeline.

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. (GILD), Alexion Pharmaceuticals, Inc. (ALXN) and Medivation, Inc. (MDVN). While Gilead carries a Zacks Rank #1 (Strong Buy), Alexion and Medivation are Zacks Rank #2 (Buy) stocks.

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