Amgen trial success comes at the expense of Novartis (AMGN, NVS)

July 7, 2009 · Filed Under General 

Amgen Inc’s (Nasdaq: AMGN)’s osteoporosis drug Denosumab did so well in a head-to-head Phase III trial vs. the current standard drug, Novartis Inc.’s (NYSE:  NVS) Zometa, that the Amgen’s drug may become the new standard for patients with breast cancer.

Denosumab was superior to Zometa by about 18 percent in delaying the time to the first bone fracture, radiation or surgery, or spinal cord compression in patients with breast cancer in which the disease has spread to the bone. Denosumab also delayed the time to the first and subsequent such skeletal-related events by 22 percent, among more than 2,000 patients involved in the late-stage study.

The strong trial results appear to be raising hopes that Denosumab also will perform well in two upcoming Phase III trials. One is for solid tumor/multiple myeloma in which results could be available later this year. The other is a trial of prostate cancer patients in which the disease has spread to the bone.

Among the various classes of breast cancer patients, it’s possible that swapping out Zometa for Denosumab could result in more than $1 billion of incremental revenue for Amgen over the next three to five years.

As far as safety data goes, the company said the overall incidence of adverse events was consistent with what has previously been reported. But osteonecrosis of the jaw, which had not been observed in previously reported Phase III studies of the drug, was seen in about 1 percent of cases — roughly the same as in Zometa.

Overall, the data appears to open up a large potential market share opportunity for Amgen at the expense of Novartis. – Mike Tarsala.

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