Keryx's Auryxia and Vifor-FMC's Velphoro Slowly Gaining Share in the Phosphate Binder Market While Big Shifts in CKD-MBD Loom With the Pending Introduction of Amgen's Parsabiv

EXTON, Pa., May 10, 2017 /PRNewswire/ -- In a market long dominated by Sanofi-Genzyme's Renvela, there are signs that the newer non-calcium, iron-based binders (Keryx's Auryxia and Vifor-FMC's Velphoro) are beginning to make in-roads with future share projections offsetting Renvela.

About half of the nephrologists and RDs surveyed report use of both Auryxia and Velphoro, and 80% have incorporated at least one of these newer agents into their treatment regimens for patients on hemodialysis. The opportunity to drive patient switches from the most common first line binders – calcium agents and Renvela – is ever-present with respondents estimating that at any given time more than one-third of their patients are above the target level for phosphorus. Thus far, Velphoro is positioned as the "low pill burden binder," a message reinforced by sales representatives and a highly desirable trait in a phosphate binder. However, MDs and RDs both point to "patient preference for other binders" as one of the leading barriers to increased use of Velphoro. Auryxia is distinguished from the other binders by its dual-action effect on phosphorus and anemia parameters, which is largely viewed as positive, but can also be a barrier, particularly among users of the drug. Keryx recently filed a sNDA for Auryxia as a treatment for iron-deficiency anemia (IDA) in CKD non-dialysis patients which, if approved, could be a game changer for the brand. Both Auryxia and Velphoro are expected to see significant share increases in the next six months.

Recent launches in the renal market have typically been associated with slow uptake, largely hampered by limited market access. This is also true for Opko's Rayaldee, a vitamin D3 prohormone launched in November 2016. However, Opko also faces other challenges as well, including an inferior promotional rate (compared to phosphate binders and Sensipar), low familiarity among nephrologists, and a lack of a perceived unmet need for the product. Indeed, just 6% of the surveyed nephrologists reported any trial of Rayaldee at the four month mark and two-thirds have not had any contact with a sales representative since the product was launched.

By contrast, Amgen's Parsabiv, a recently approved IV calcimimetic, is expected to become available later this summer and could make a big impact. While nephrologists are still struggling to understand the reimbursement scenario for Parsabiv and its oral classmate Sensipar, there is excitement in the nephrology community about the ability to control drug delivery in order to achieve better outcomes in SHPT. The potential upside is massive for Amgen. Not only are patients currently treated with Sensipar candidates for Parsabiv, but nephrologists estimate that about 20% of calcimimetic-naïve patients – those who cannot tolerate, afford or remain compliant with Sensipar – could also potentially be treated. The importance of promotion and manufacturer support will also play to Parsabiv's advantage, as nephrologists and RDs identify Amgen as the most supportive company in the CKD-MBD space and representative contact rates are already high. According to Dr. Jay Wish, M.D., Professor of Clinical Medicine at Indiana University School of Medicine, “The availability of Parsabiv provides clinicians with the ability to improve SHPT outcomes in our hemodialysis patients.  By having a formulation that can be administered by our dialysis nursing staff, instead of relying on patient adherence to daily oral medication that is not well-tolerated, we can be more confident that patients are receiving an optimal calcimimetic dose.  In addition to improvements in SHPT, consistent dosing of Parsabiv may also improve phosphate control, enabling lower doses of phosphate binders.”

On the horizon is Ardelyx's tenapanor, a NHE3 transport inhibitor, being developed for hyperphosphatemia in ESRD. Among the nephrologists surveyed, three-quarters report high interest in tenapanor, drawn largely to its novel mechanistic approach and more favorable dosing requirements compared to phosphate binders. If ultimately approved, tenapanor will provide another option for tackling a highly prevalent and challenging condition faced by hundreds of thousands of dialysis patients.

RealTime Dynamix: Bone and Mineral Metabolism is an independent report series published each quarter. The series tracks the evolution of the CKD-MBD market, provides a deep dive on launch effectiveness and highlights opportunities for pipeline agents. The next update will be published in June 2017.

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