Amgen’s (AMGN) Xgeva was launched commercially in 2010 and is marketed primarily in the US and Europe. The drug crossed the $1 billion annual revenue mark in 2013.
Xgeva has turned out to be a consistently high revenue-generating drug for the company. In 2016, Xgeva sales grew 9% year-over-year to reach ~$1.5 billion.
Xgeva (denosumab) is a receptor activator of nuclear kappa-B ligand (or RANKL) inhibitor monoclonal antibody utilized for inhibition of skeletal-related events (or SREs) in patients with bone metastases due to solid tumors, osteoporosis, and giant cell bone tumor.
Factors expected to drive growth in 2017
In April 2017, Amgen announced the submission of supplemental biologics license application to the FDA and another application to European Medical Agency (or EMA) for Xgeva after its Phase 3 clinical trials. These applications seek approval for expanding the indication of the drug to include multiple myeloma patients.
Xgeva showed superiority over zoledronic acid in preventing SREs in patients with multiple myeloma. According to American Cancer Society estimates, ~30,280 new cases of multiple myeloma are expected to be diagnosed in 2017.
Amgen implemented a strategic collaboration with Dr. Reddy’s Laboratory (RDY) to commercialize its oncology and osteoporosis therapies in India. Owing to this collaboration, Xgeva’s sales volumes are expected to rise modestly in 2017.
The approval of the drug in the US and Europe for multiple myeloma is expected to further push the sales volume and may have a favorable impact on Amgen’s stock price as well as the Vanguard Total Stock Market ETF (VTI). Amgen makes up about 0.48% of VTI’s total portfolio holdings.
In the next article, we’ll discuss Amgen’s biosimilar portfolio in detail.