Secondary hyperparathyroidism franchise
Amgen (AMGN) has filed an application with the FDA seeking approval for its oral calcimimetic, Sensipar, as a therapy for pediatric patients with secondary hyperparathyroidism. Already approved for adults in this indication, the drug is also sold under the brand name Mimpara in Europe.
In 2016, Sensipar earned ~$1.5 billion in revenues, which represents year-over-year (or YoY) growth of ~12%. Sensipar continues to pose strong competition to peers such as AbbVie’s (ABBV) Zemplar, Sanofi’s (SNY) Hectorol, and Teva Pharmaceutical’s (TEVA) generic Zemplar.
In 2017, Amgen is expected to advance its commercial strategy for Parsabiv by launching the drug in around ten markets in Europe. After securing regulatory approval from the FDA on February 7, 2017, Parsabiv is also scheduled to be launched in the US. Amgen expects to complete the reimbursement-related process for Parsabiv with Medicare Part B by mid-2017.
Parsabiv is indicated as a therapy for secondary hyperparathyroidism in adult patients already suffering with kidney disease and requiring dialysis. Currently, Parsabiv is the only calcimimetic agent that can be delivered intravenously coinciding with hemodialysis sessions. The prescribed dosage frequency is around three times a week.
If Parsabiv captures a significant portion of the secondary hyperparathyroidism market, it may have a positive effect on Amgen stock and on the Vanguard Total Stock Market ETF (VTI). Amgen makes up about 0.53% of VTI’s total portfolio holdings.
In the next article, we’ll study Amgen’s erythropoiesis-stimulating agents in greater detail.