Amgen Submits for Denosumab - Analyst Blog

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) recently submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for its key pipeline candidate, denosumab. The company is seeking approval for the use of denosumab in delaying skeletal related events in patients with advanced cancer.

The BLA includes data from several studies including three pivotal phase III studies that compared denosumab with

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) Zometa. Amgen has plans to seek approval for this indication in other territories as well including the European Union, Switzerland, Canada, Australia and Japan. Amgen has a collaboration and licensing agreement with Daiichi-Sankyo for Japan.

Denosumab is currently under FDA review for another indication. Amgen is currently seeking approval for the use of denosumab (proposed trade name: Prolia) for the treatment of postmenopausal osteoporosis (PMO). A response from the FDA should be out by July 25, 2010.

Denosumab is the future of Amgen. Based on encouraging phase III results, we believe the candidate 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.

With all its key products slated to lose patent protection in the next few years, Amgen has a lot riding on the timely approval of denosumab. As such, the drug’s failure to receive first-round FDA approval was a setback for the company. We are bullish on the drug, but any hiccup, either with respect to a further delay at the FDA or safety concerns post-launch, will weigh heavily on the shares.

Once approved for the PMO indication, denosumab will compete with

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) Fosamax,

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) Boniva,

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) Evista and Forteo among others. We are currently Neutral on Amgen.