Amgen's bone drug Prolia nabs data for new use on its way to blockbuster sales

Amgen notched up data for a new Prolia use that could amp up the blockbuster-in-the-making. In a late-stage trial, Prolia beat Allergan’s Actonel at building bone density in the hip and spine in patients who suffer from glucocorticoid-induced osteoporosis.

Amgen R&D chief Sean Harper said that glucocorticoid therapy’s potential to weaken bones is "frequently underestimated.” In patients taking the drugs--including the commonly used steroid prednisone--Prolia (denosumab) delivered a 4.4% increase in density in the lower spine and a 2.1% increase in the hipbone, compared with Actonel’s 2.3% and 0.6%, the study found.

Prolia is one of Amgen’s bigger growth drivers now, and with biosimilar competition rearing its ugly head, the California-based biotech needs all the help it can get. Last year, Prolia delivered a 27% increase in sales to $837 million, and so far this year, with $286 million in Q2 sales, Prolia is on track to break the $1 billion blockbuster barrier.

Meanwhile, Novartis’ Zarxio is targeting Amgen’s Neupogen brand, and the Swiss drugmaker has a biosim version of Amgen’s $5 billion seller, Enbrel, in the works. That potential rival, dubbed GP2015, won unanimous backing from an FDA advisory panel last month, but Amgen has already sued Novartis’ Sandoz unit for patent infringement, to hold off a launch as long as possible.

On the bright side, Amgen got a reprieve from a Neulasta biosimilar last month, when the FDA turned back Sandoz's version of that drug.

A new use for Prolia would give that drug a bigger market to target, and thus more opportunity to help Amgen fill the biosimilars gap. It’s not just long-term prednisone users who suffer declines in bone density, either. Patients new to glucocorticoid therapy can see density decline significantly within the first three months, Amgen says. And in the newly released study, those new to steroid therapy saw a 3.8% improvement in spine density and a 1.7% improvement in hip density with Prolia, compared with 0.8% and 0.2% with Actonel.

"We are excited that these data support the potential for Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease,” Harper said in a statement.

Denosumab is also sold in the cancer market under the brand name Xgeva, where it brought in $275 million for Q2 and more than $1 billion for 2015. Both it and Prolia are anticipating stepped-up growth in emerging markets, after GlaxoSmithKline sold back the rights to both drugs in a slate of countries in Asia and Latin America.

Special Report: Top 15 drug launch superstars - Xgeva/Prolia, Amgen

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