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Amgen's AMG 416 Succeeds in Phase III, Shares Up

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Amgen Inc.’s (AMGN) shares were up 2.5% following the company’s announcement that AMG 416 (formerly known as velcalcetide) has met the primary as well as secondary endpoints in a randomized, double-blind, placebo-controlled 26-week long phase III study.

The study evaluated the efficacy and safety of AMG 416 in 515 chronic kidney disease (:CKD) patients receiving hemodialysis and suffering from secondary hyperparathyroidism. Results showed that patients on AMG 416 achieved a statistically significant reduction in parathyroid hormone levels compared to patients on placebo (75.3% versus 9.3%).

Secondary hyperparathyroidism is a serious condition that occurs frequently and often advances in patients suffering from CKD. According to the press release issued by Amgen, secondary hyperparathyroidism affects a considerable number of patients out of almost two million dialysis-dependent patients across the world.

We remind investors that AMG 416 became a part of Amgen’s portfolio following its Jul 2012 acquisition of KAI Pharmaceuticals, Inc. These are the first phase III data reported on AMG 416.

Amgen intends to announce results from another placebo-controlled study later this year. Amgen is also conducting a head-to-head study evaluating AMG 416 in comparison with Sensipar. Results should be out in 2015.

Meanwhile, Amgen is working toward strengthening its pipeline. We expect 2014 to be a catalyst rich year for Amgen as it gears up to present data on several late stage candidates.

Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Actelion Ltd. (ALIOF), The Medicines Co. (MDCO) and Biogen Idec Inc. (BIIB). All these stocks carry a Zacks Rank #1 (Strong Buy).

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