Analysts see positive future for Amgen's bone metastases drug denosumab following strong Ph III data

10 February 2010

US biotechnology major Amgen received a boost recently when the company announced positive results from a pivotal head-to-head Phase III study that was conducted with the firm's main pipeline candidate, denosumab. The study compared denosumab with Swiss drugmaker Novartis' Zometa (zoledronic acid) in the treatment of bone metastases in 1,901 patients with advanced prostate cancer.

The company recently said it expects to submit its response soon to the US Food and Drug Administration regarding a complete response letter it received for its denosumab in the treatment and prevention of postmenopausal osteoporosis (The Pharma Letter January 13). The proposed trade name for this indication is Prolia. Analysts at Zacks Equity Research believe approval for this indication could come in the second half of 2010.

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