Spherix Global Insights

November 14, 2017

In the CKD-MBD Market, OPKO’s Rayaldee Continues to Struggle While Keryx’s Auryxia Gains Momentum, According to Latest Quarterly Update from Spherix Global Insights

Amgen’s Parsabiv, having finally received a J-code effective January 2018, is poised for rapid uptake in the dialysis market, not only off-setting Amgen’s own Sensipar but expanding the calcimimetic-treated population overall

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EXTON, Pa., Nov. 14, 2017 /PRNewswire/ — A survey of over 200 US nephrologists fielded in late September indicates that, while many changes are afoot in the bone and mineral metabolism space, the launch of Rayaldee appears to be at a standstill. Despite Q3 reports in OPKO’s earnings call about the growth in Rayaldee prescription volume, the survey results detected no notable expansion in the user base of Rayaldee, which remained at a meager 12%. Nephrologists continue to question the differentiation from generic vitamin D, although users of the drug have a favorable view of it as a hybrid of nutritional and active vitamin D. In addition to lacking clear clinical benefits compared to generic alternatives, after nearly a year post-launch, the leading barrier is still limited familiarity and OPKO faces a growing percent of nephrologists who do not see a role for Rayaldee in their practice. Market access issues are also plaguing uptake, particularly for current users, and less than 10% of the respondents indicate that this has improved over the past six months. Finally, the recent update to the KDIGO Clinical Practice Guideline for CKD-MBD left an ambivalent role for Rayaldee and according to one respondent “…the guidelines seem to indicate Rayaldee is a good choice – they did NOT, however, endorse it as a recommendation. The statement was a bit vague and left more questions than answers.”

In contrast to Rayaldee’s stagnant position, use of the iron-based phosphate binders (Velphoro from Vifor-Fresenius Medical Care Renal Pharma and Auryxia from Keryx) seems to be accelerating in the hyperphosphatemia market with more than 40% of the respondents reporting increased use of these brands in the past three months. Auryxia in particular saw a sharp uptick in its user base, surpassing that of Velphoro for the first time since launch. Indeed, heavy promotion is evident with both brands with close to half of the nephrologists reporting increased promotion in the past three months. By comparison, 40% report decreased promotion with Sanofi Renal’s Renvela, which is beginning to see erosion from generic challengers. And in this market, promotion matters. Nephrologists that have had a call with the Velphoro or Auryxia representative in the past month project more than double the brand share compared to those who have not been called on.

Looking forward, significant increases are expected to continue for Auryxia and Velphoro in the phosphate binder / dialysis market, while use of calcium-based agents is projected to decline. With the recent approval of Auryxia for iron-deficiency anemia in chronic kidney disease, the potential for this brand to move more “upstream” loom large. The other future change expected to disrupt the CKD-MBD market beginning in early 2018 is the official launch of Amgen’s IV calcimimetic, Parsabiv. The majority of respondents have been detailed on Parsabiv by the Amgen representative and 80% expect to convert at least some of their Sensipar patients to Parsabiv, though in the large dialysis organizations (DaVita and Fresenius) this will not happen until protocols are firmly in place. According to nephrologists, early messaging outlines the advantages of Parsabiv over Sensipar in terms of efficacy, tolerability and adherence. The uptake of Parsabiv will be closely followed in the 2018 quarterly report series.

On the development front, nephrologists are anticipating a wide range of new therapeutic options for diabetic nephropathy (AbbVie’s atrasentan, Bayer’s finerenone, Janssen’s canagliflozin), renal anemia (via HIF-PH inhibitors roxadustat from AstraZeneca/Fibrogen/Astellas, vadadustat from Akebia/Otsuka and daprodustat from GSK), hyperphosphatemia (Ardelyx’s tenapanor) and products to improve vascular access (vonapanitase from Proteon Therapeutics). While the highest percent of nephrologists desire one of the diabetic nephropathy assets, largely for the sheer prevalence of the condition and lack of options, more than half of the respondents report a high need for new agents to treat hyperphosphatemia in dialysis and tenapanor offers high appeal due to its novel mechanism of action.

RealTime Dynamix™: Bone and Mineral is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development.

About Spherix Global Insights
Spherix Global Insights is an independent market intelligence agency, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

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For more information contact:
Robbie McCarthy, Chief Strategy Officer
Email: [email protected]

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