Amgen Inc. (AMGN) recently announced that the US Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) of Xgeva (denosumab). Amgen is seeking to get Xgeva approved for the reduction of the risk of developing bone metastases in men with castrate-resistant prostate cancer.
Amgen had filed the sBLA for the drug in June 2011. The application was based on data from a late-stage study ('147) that was conducted in 1,432 men with castrate-resistant prostate cancer. Results from the study showed that Xgeva improved median bone metastasis-free survival by 4.3 months compared to placebo.
We note that approval would make Xgeva the first therapy for the prevention or delay of spread of the cancer to the bone. Further, we believe that Xgeva sales should receive a major boost if Amgen succeeds in gaining approval for the prevention of bone metastases in prostate cancer patients. According to the company, up to 90% of men with advanced prostate cancer have their tumor spread to the bone.
Xgeva, which is already approved in the US (November 2010) and European Union (EU; July 2011) for the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors, is off to a strong start with second quarter 2011 sales coming in at $73 million, up from the $42 million reported in the first quarter.
Amgen is currently seeking approval of Xgeva in other countries including Australia, Mexico, Russia, Japan and Switzerland, for the prevention of SREs. While Daiichi Sankyo is Amgen’s licensing partner in Japan, Amgen has a collaboration agreement with GlaxoSmithKline plc (GSK) in countries where it does not have a commercial presence.
Denosumab is also marketed under the trade name Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of fractures or patients who have failed or are intolerant to other osteoporosis treatments.
Amgen launched Prolia in both the US and the EU in the second quarter of 2010. Second quarter 2011 sales for the drug came in at $44 million, significantly up from first quarter sales of $27 million.
Neutral on Amgen
We currently have a Neutral recommendation on Amgen. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We expect investor focus to remain on the successful commercialization of Prolia/Xgeva.
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