Amgen (AMGN) is looking to gain approval for additional indications of Xgeva. The company recently submitted a supplemental Biologics License Application (sBLA) seeking US Food and Drug Administration (FDA) approval for Xgeva (denosumab) for the reduction of the risk of developing bone metastases in men with castrate-resistant prostate cancer. Approval would make Xgeva the first therapy for the prevention or delay of the spread of cancer to the bone.
Amgen’s application is based on data from a pivotal phase III study ('147) that was conducted in 1,432 men with castrate-resistant prostate cancer. Results from the ‘147 study showed that Xgeva improved median bone metastasis-free survival by 4.3 months compared to placebo.
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 will have their tumor spread to the bone.
Xgeva was approved by the FDA in Nov 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva is off to a strong start with first quarter 2011 sales coming in at $42 million, up from the $8 million reported in the fourth quarter of 2010.
Amgen is currently seeking approval in other territories including the EU, Australia, Mexico, Russia, Japan and Switzerland. While Daiichi Sankyo is Amgen’s licensing partner in Japan, Amgen has a collaboration agreement with GlaxoSmithKline (GSK) in countries where it does not have a commercial presence.
Denosumab is also available 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.
Neutral on Amgen
We currently have a Neutral recommendation on Amgen. We expect investor focus to remain on the successful commercialization of Prolia/Xgeva.
AMGEN INC (AMGN): Free Stock Analysis Report
Be the first to comment