 |
| Amgen R&D chief Sean Harper |
Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.
Amgen's second trial for AMG416 came up with numbers that looked quite similar to what investigators found in round one: 74% of patients achieved a greater than 30% reduction in the level of parathyroid hormone, compared to only 8.3% in the placebo arm, hitting the primary endpoint. Investigators will now have to be patient until the final leg of the Phase III journey is wrapped in 2015, comparing AMG416 with its own drug, Sensipar.
The latest upbeat assessment of AMG416 helps secure Amgen's hopes for its late-stage pipeline, which was beefed up ahead of the biotech giant's recent decision to restructure its R&D operations, shuttering a research campus in Seattle along the way as it follows its rivals into the big research hubs in Boston and closer to home in San Francisco. Other late-stage efforts includes a big rivalry with Sanofi ($SNY)/Regeneron ($REGN) for a new PCSK9 cholesterol therapy.
Amgen picked up AMG416 in its $315 million buyout of KAI Pharmaceuticals, which was triggered as R&D chief Roger Perlmutter--who's now running research at Merck--was squeezed out at Amgen.
Secondary hyperparathyroidism is often found among dialysis patients whose parathyroid glands kick into action as kidney function declines, generating dangerous amounts of the hormone as the body tries to maintain the proper level of calcium and phosphorus. Amgen sells Sensipar, an oral drug, for the condition, but believes it can open up a significant new market for this IV formulation. A study for Sensipar (cinacalcet) in children was halted early last year following the death of one of the test subjects.
AMG416 isn't without side effects. Adverse events like a drop in blood calcium and nausea were higher in the drug arm than in the placebo group. But the placebo arm nevertheless experienced a higher rate of serious adverse events. Now Amgen will see how the drug compares to Sensipar with the last batch of data due out next year, which could lay the foundation for a regulatory application.
"The results from this second Phase III study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Amgen R&D chief Sean Harper in a statement. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
- here's the release