Amgen’s Date With The FDA

The US Food and Drug Administration (FDA) recently accepted Amgen, Inc.’s (AMGN: 56.38 0.00 0.00%) complete response submission for Prolia, the company’s lead pipeline candidate, and established an action date of Jul 25, 2010. Amgen is seeking approval for the use of Prolia (denosumab) for the treatment of postmenopausal osteoporosis (PMO). 

Amgen had initially submitted a Biologic License Application (BLA) for Prolia in Feb 2009. However, Amgen faced a setback in Oct 2009 when the FDA’s Division of Reproductive and Urologic Products issued a complete response letter asking the company to submit additional information. Amgen submitted its response to the FDA’s complete response letter in late Jan 2010. 

Among other things, Amgen was asked to submit further information on the design of its previously submitted post-marketing surveillance program. The agency also asked the company to provide all updated safety data related to Prolia. 

In addition to seeking approval for the treatment of PMO, Amgen is also looking to get Prolia approved for the prevention of PMO and the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients. 

We believe Prolia represents 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, which represents huge commercial potential. 

It is estimated that about 8 million women suffer from osteoporosis in the US . The clinical results on Prolia so far are positive for the company, and reinforce our belief that the drug could be a blockbuster. 

We currently have a Neutral recommendation on Amgen. We expect investor focus to remain on the approvability of Prolia. With all the key products expected to lose patent protection in the next few years, Amgen has a lot riding on the timely approval of Prolia. 

The FDA has established an action date of July 25 for Prolia. We are bullish on Prolia, but any hiccup, either with respect to a further delay at the FDA or safety concerns post-launch, will weigh heavily on the shares.