Amgen's Kyprolis stands its ground against new J&J, BMS rivals


The good news for Amgen: Multiple myeloma med Kyprolis isn’t ceding share in its more important lines of therapy. The bad news? It isn’t hitting sales estimates, either.

Last week, the Big Biotech’s commercial EVP, Tony Hooper, told investors on a conference call that a spate of newly approved myeloma drugs isn’t infringing on its slice of the pie in the second- and third-line patients.

While the data is still “quite shallow,” Hooper said he sees Kyprolis “continue to hold market share in third line. I see continued growth in the second line. And I see the newer entrants with very slow single-digit market shares and predominantly being used in fourth-line plus.”

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Those newer entrants--Takeda’s Ninlaro, Johnson & Johnson’s ($JNJ) Darzalex and Bristol-Myers Squibb ($BMY) and AbbVie’s ($ABBV) Empliciti--snagged rapid-fire FDA approvals late last year. But Amgen ($AMGN) has been able to hold off the newcomers thanks to a recent addition of ENDEAVOR trial data to its label, Hooper said.

That head-to-head study, unveiled last year, demonstrated Kyprolis’ superiority versus Takeda myeloma giant Velcade. The data helped it win a coveted second-line approval in tandem with chemo drug dexamethasone. And that regulatory go-ahead gave Amgen both a doublet regimen and a triplet regimen--consisting of Kyprolis, dexamethasone and Celgene’s ($CELG) Revlimid--in the second-line setting.

Overall, that go-ahead helped Kyprolis grow 43% year-over-year, Amgen said. There’s just one problem: Sales still aren’t measuring up to analysts’ expectations. The treatment’s $154 million haul in Q1 fell short of the $173 million Wall Street predicted, an occurrence that hasn’t been uncommon for Amgen since it bought Kyprolis-maker Onyx back in 2013.

But Hooper expects the drug to turn around, considering that patients in earlier lines of therapy tend to stay on their treatments longer. “We expect sales to continue to grow as we treat more second-line patients,” he told investors.

And international rollouts should help toward that goal, too. Outside the U.S., “we are making good progress with our launches,” he said.

- see the call transcript 

Special Reports: Pharma's top 10 M&A deals of 2013 - Amgen/Onyx | Top 15 drug launch superstars - Kyprolis - Onyx Pharmaceuticals

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Amgen's Kyprolis wins 'backbone therapy' FDA nod after trumping Velcade in trial
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