Is Amgen's ($AMGN) new bone drug destined to be "one of the biggest cancer drugs ever?" New data shows that Xgeva (denosumab) delayed the spread of prostate cancer into bone, and that's set the oncology world abuzz. Not to mention stock analysts, who see the drug's success in staving off prostate cancer as a harbinger of similar success with breast cancer.
And that, says Cowen & Co.'s Eric Schmidt, could add $2 billion to annual Xgeva sales. "If it also works in breast cancer prevention, Xgeva could become one of the biggest cancer drugs ever," Schmidt told Bloomberg. "No drug has ever before shown the ability to prevent bone metastases."
A breast cancer indication is something of a holy grail for oncology drugs. Amgen started a trial in June to test Xgeva's ability to prevent breast cancer from spreading to bone; designed to enroll 4,500 women, the study won't produce results till 2016.
Meanwhile, the company will slice and dice the new prostate cancer data--and meet with FDA--to decide whether to apply for a prostate cancer approval. RBC Capital Markets' Michael Yee predicted that a prostate-cancer indication alone could be worth plenty: "This is a potential $500 million to $1 billion opportunitiy," he told Reuters.
Though the drug did delay the spread of cancer to bone by 4.2 months, it didn't appear to increase overall survival. That puts the new data "at the low end of what would be considered clinically meaningful," ISI Group analyst Mark Schmidt wrote in a note to investors. But Amgen's Roger Perlmutter told the New York Times that the trial wasn't expected to show a survival benefit because most patients lived, and because patients whose cancer did spread were taken out of the trial altogether for a change in treatment.