Amgen exec: Don't blame J&J rival Darzalex for Kyprolis' latest sales shortfall

Kyprolis

Another quarter, another miss for Amgen’s multiple myeloma treatment Kyprolis. But don’t blame new competition from Johnson & Johnson, the company’s execs say.

Last week, the Big Biotech reported $172 million in Kyprolis sales--a haul that fell short of the $185 million analysts expected to see. And it’s hardly the first time the cancer-fighter has come up short: It did so in Q1 of this year, and it’s also missed several times since Amgen in 2013 shelled out close to $10 billion to pick up Kyprolis’ maker, Onyx Pharmaceuticals.

But while some analysts posited that new rival Darzalex, a J&J med approved late last year for use in the fourth-line setting, may be getting in the way of Kyprolis meeting its targets, the California company’s commercial chief, Tony Hooper, insisted on the Q2 conference call that that’s not the case.

“Most of the usage we’ve seen with Darzalex at the moment is fourth-line plus,” he told investors, echoing comments he made on the Q1 call and laying to rest concerns about off-label use in earlier lines of therapy.

“Based on the data we’ve seen, Darzalex is clearly a good product,” he acknowledged. But instead of squaring off as nemeses, the meds will be used in tandem “as a future regimen in treating multiple myeloma,” he predicted.

Meanwhile, though, if J&J gets its way with U.S. regulators, second-line Darzalex use may not be off-label for long. Last week, the product won the FDA’s breakthrough designation as a treatment for multiple myeloma patients who’ve relapsed after just one or more prior therapies.

If Darzalex can snag that green light, it’ll certainly put more heat on Kyprolis, which only recently nabbed its own second-line green light. But it’ll also help give J&J a boost in its battle with Takeda and an AbbVie/Bristol-Myers Squibb pairing. Those two companies won FDA approval for their own contenders--Ninlaro and Empliciti, respectively--late last year as well.

- 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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