Zacks_Analysts' Blog : FDA Panel to Review Amgen's Xgeva - Analyst Blog

Amgen’s (AMGN) Xgeva (denosumab) will be coming up for review before the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012. Amgen is looking to get Xgeva approved for the treatment of men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

FDA Action Date: April 26, 2012

The company had submitted a supplemental Biologics License Application (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 more than 4 months compared to placebo. A final response from the FDA should be out by April 26, 2012.

We note that approval would make Xgeva the first therapy for the prevention or delay of spread of cancer to the bone in men with non-metastatic CRPC. Xgeva sales would receive a major boost if Amgen succeeds in gaining approval for the delay or prevention of bone metastases in prostate cancer patients.

Xgeva, which is already approved in the US (November 2010), European Union (July 2011) and a few other countries for the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors, is off to a strong start with sales coming in at $217 million in the first nine months of 2011.

Amgen is currently seeking approval of Xgeva in other countries for the prevention of SREs. 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 marketed under the trade name Prolia. Prolia is approved in the EU and the US 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. Prolia is also approved in the EU for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Meanwhile, the FDA also granted approval to Prolia for increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

Amgen launched Prolia in both the US and the EU in the second quarter of 2010. Prolia sales in the first nine months of 2011 were $122 million.

Neutral on Amgen

We currently have a Neutral recommendation on Amgen, which carries a Zacks #3 Rank (short-term Hold rating). With several key products expected to lose patent protection in the next few years, Prolia/Xgeva’s successful commercialization and approval for additional indications are important events for the company.