EXTON, Pa., June 25, 2019 /PRNewswire/ -- According to a survey of 202 nephrologists in late May, use of Parsabiv (etelcalcetide) flatlined between Q1 and Q2, the first quarter to not see significant gains since launch. Although use of Parsabiv showed continued quarter over quarter gains in small and medium sized dialysis chains (SDO/MDOs), strict protocols largely requiring failure on Amgen's own oral calcimimetic, Sensipar (cinacalcet), are preventing further uptake of the drug in LDOs (DaVita and Fresenius Medical Care). As a result, Parsabiv share in SDO/MDOs is nearly four times that of the LDOs. Adding to Amgen's renal woes, at-risk generic challengers to Sensipar are rapidly eroding use of the brand, with Sensipar revenue falling 63% in the US between Q4 2018 and Q1 2019 to the tune of $232 million according to remarks during Amgen's Q1 2019 earnings call1. Without quick and extensive loosening of protocols, Parsabiv simply cannot close the revenue gap in the secondary hyperparathyroidism (SHPT) market.
The phosphate binder market is also largely stable with iron-based phosphate binders such as Akebia's Auryxia (ferric citrate) and Vifor Fresenius Medical Care Renal Pharma's Velphoro (sucroferric oxyhydroxide) making slow but steady gains in market share. Indeed, since Q3 2015 when Spherix first began tracking the market on a quarterly basis, nephrologist-reported share of calcium-based phosphate binders in the hemodialysis setting has declined from an estimated 45% to 31%, while use of iron-based phosphate binders has steadily increased, boasting a collective current share in excess of 20%. Use of sevelamer (Renvela/sevelamer generics) has held steady during this time, although nephrologists do report projected offsets in favor of Auryxia and Velphoro in the near future.
A parallel study with 99 renal dietitians (RDs), who tend to be on the front line when it comes to the management of hyperphosphatemia, was conducted in May 2019 and reveals similar trends. Compared to nephrologists, RDs report even more robust use of the iron-based binders as well as more frequent interaction with Auryxia and Velphoro sales representatives. Nephrologists primarily affiliated with FMC units and RDs working in these units report significantly higher use of Velphoro compared to those primarily affiliated with or working in other chains. This is likely a reflection of increased "encouragement" reported by physicians and dietitians to use this binder in which the chain has an ownership stake.
One thing nephrologists and RDs do agree on is the high unmet need for new agents to treat hyperphosphatemia. With both groups reporting that nearly 40% of their binder-treated hemodialysis patients are above the target level for phosphorus at any given time, there is ample room for improvement. This unmet need is reflected by the majority of nephrologists and RDs reporting high interest in Ardelyx's tenapanor, an inhibitor of the sodium-proton exchanger NHE3, which is currently in Phase 3 clinical trials. According to one respondent who views tenapanor as the most promising among pipeline agents, "Current phosphate binders are inadequate, we need a new mechanism."
In the non-dialysis setting, Opko still struggles to make in-roads with Rayaldee (extended release calcifediol) with market access issues presenting the greatest barrier. Additionally, many physicians are still not convinced that Rayaldee offers any advantages over other nutritional or active vitamin D options, many of which are generic and inexpensive. As a result, despite a 52% year over year increase in the reported number of patients on drug, the user base has been flat over the past couple of quarters. On the plus side, it does appear that Rayaldee's positioning as a novel vitamin D treatment with benefits of both nutritional and active vitamin D has taken hold with those who have adopted the drug, but the naysayers outnumber the supporters, keeping big leaps in growth at bay for the foreseeable future.
The next wave of the CKD-MBD study will field in late July. Spherix quarterly updates for the renal anemia market are scheduled to be released this week.
1 Source: Amgen Earnings Conference Call, http://phx.corporate-ir.net/phoenix.zhtml?c=61656&p=SH30
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SOURCE Spherix Global Insights