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Good News For Amgen (AMGN) As Parathyroid Drug AMG 416 Succeeds In Phase 3 Study

8/18/2014 3:58:43 PM

Good News For Amgen As Parathyroid Drug AMG 416 Succeeds In Phase 3 Study Good News For Amgen As Parathyroid Drug AMG 416 Succeeds In Phase 3 Study

August 19, 2014
By Mark Terry, Breaking News Staff

Thousand Oaks, California-based Amgen (AMGN) announced that a Phase 3 study of AMG 416 met its primary and all secondary endpoints. The trial was a second placebo-controlled study for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) that are receiving hemodialysis.

The study ran for 26 weeks and was randomized, double blind, and placebo controlled, looking at 508 patients with CKD receiving hemodialysis. With each hemodialysis treatment, patients received AMG 416 or a placebo three times per week by intravenous injection. Standard treatment was also provided.

“Despite the variety of options available for the treatment of this disease,” said Sean E. Harper, M.D., executive vice president of Amgen’s Research and Development, said, “an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of ahead-to-head study evaluating AMG 416 compared to cinacalcet next year.”

AMG 416 is a novel calcimimetic agent that binds to the calcium-sensing receptor on the parathyroid gland. This activates the receptor and decreases PTH. Secondary Hyperparathyroidism is common in patients with CKD and affects about two million people worldwide who undergo dialysis. As a response to decreased kidney function, the parathyroid glands up the production of PTD in an attempt to maintain normal levels of calcium and phosphorus.
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The results of this study suggest that AMG 416 could become a good treatment for dialysis patients with secondary hyperparathyroidism. This is good news for Amgen, which has had a mixed bag of announcements lately. Recent stories included the recall of nine packaged lots of anemia medication Aranesp® (dardepoetin alfa) in Europe and the Middle East. However, Amgen announced thyroid drug AMG 416 had positive results in a Phase 3 clinical study and the company’s drug Kyprolis® for relapsed multiple myeloma met primary endpoints in its ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone treatment of PatIents with Relapsed Multiple MyEloma) trial.

With the successful completion of this trial, Amgen is one study away from regulatory filings. About 74% of patients in the study showed more than a 30% decrease in the level of parathyroid hormone, compared to 8.3% in the placebo group. In the final stage of the Phase 3 trial, which is expected to be completed in 2015, AMG 416 will be compared to another Amgen drug, Sensipar®.

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