Positive Results on Amgen Drug

Amgen Inc. (AMGN - Analyst Report) received a boost recently when the company announced positive results from a pivotal head-to-head phase III study that was conducted with Amgen’s main pipeline candidate, denosumab. The study compared denosumab with Novartis’ (NVS - Snapshot Report) Zometa in the treatment of bone metastases in 1,901 patients with advanced prostate cancer. 

Amgen announced that denosumab met the primary and secondary endpoints of the study. Denosumab demonstrated superiority over Zometa in delaying the time to the first on-study skeletal related event (SRE) and reducing the rate of multiple SREs. Both results were statistically significant. Amgen’s shares were up about 2.7% in after-hours trading on the news. 

Amgen reported that overall rates of adverse events and serious adverse events, including infections, were similar in the two treatment arms. While the rate of incidence of osteonecrosis of the jaw was higher in the denosumab arm (22 patients versus 12 in the Zometa arm), the difference was not statistically significant. Amgen intends to present full results at the American Society for Clinical Oncology meeting in early June. 

The company had earlier presented results from two other phase III studies that were conducted with denosumab for the treatment of bone metastases. Amgen intends to include data from these studies and the head-to-head Zometa study when it applies for regulatory approval of the candidate in advanced cancer later this year. 

Meanwhile, results from another study investigating denosumab’s efficacy in prolonging bone metastasis-free survival in prostate cancer patients are expected in the second half of the year. Denosumab, Amgen’s key pipeline candidate, is the future of the company. 

Denosumab is currently under US Food and Drug Administration (FDA) review for the treatment of postmenopausal osteoporosis (PMO). We believe approval for this indication could come in the second half of 2010. 

In our view, denosumab has the potential to capture a major share of the osteoporosis market once launched. The osteoporosis market represents huge commercial potential. The clinical results on denosumab so far are positive for the company, and reinforce our belief that the drug could be a blockbuster. 

While we are bullish on denosumab, any hiccup, either with respect to a further delay at the FDA, a miss in any of the other ongoing phase III programs, or safety concerns post-launch, will weigh heavily on the shares. We currently have a Neutral recommendation on Amgen.

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