The American Society of Nephrology (ASN) conference in Atlanta, GA is occurring this week. Chronic kidney disease (CKD) is a large market, and our recently published CKD Pharmacor estimates the G7 2012 market value at $11.1 billion dollars. For those of us following the market, there are few news items this week, which is particularly interesting and likely to be highlighted at the conference:
- Yesterday Keryx Biopharmaceuticals, who are developing Zerenex (ferric citrate), an iron-based phosphate binder, announced top line phase II results. In summary, Zerenex met all primary and key secondary endpoints in a phase 2 study of non-dialysis dependent CKD patients with elevated serum phosphorus and iron deficiency anemia.1 With these results, Keryx now has the potential to be approved for a non-dialysis indication, which would be first for any phosphate binder. In addition, according to Keryx, there will be one oral presentation, six clinical poster presentations at ASN.2
- The BioTrends' TreatmentTrends series has been following Zerenex for the past several years, covering aided familiarity, interest, and percent of patients likely to be candidates for Zerenex in both CKD non-dialysis and dialysis, after review of a product profile. As an example of our data, in the TreatmentTrends: Nephrology (US) Q3 2013 report, Zerenex's mean familiarity rating significantly increased over the same quarter last year likely because of the recent NDA submission and ongoing press and clinical activity. In addition, most surveyed nephrologists indicated they learn about the product via journals and medical meetings.
- FibroGen is expected to present data on ASN relating to roxadustat (FG 4592), an oral compound in late stage development for the treatment of anemia associated with CKD and end-stage renal disease (ESRD), with two oral presentations at ASN. One of oral presentation will be on the correction of anemia in Chinese patients and the other will evaluate the use of FG-4592 in peritoneal dialysis patients.3
- BioTrends has also been covering FG 4592 in the BioTrends' TreatmentTrends series. The TreatmentTrends: Renal Anemia 2013 (EU5) report indicates that while familiarity with FibroGen/Astellas/AstraZeneca's FG-4592/ASP1517 is low among surveyed nephrologists in the EU5 (France, Germany, Italy, Spain and the United Kingdom), close to one-half of EU5 nephrologists report a high interest in learning more about the product after reviewing a product profile. Surveyed EU5 nephrologists also indicate that 35 percent of their chronic kidney disease-non-dialysis patients and 28 percent of their dialysis patients are likely candidates for FG-4592/ASP1517.
I am sure there will be lots of other discussions around the use of ESAs under the U.S. Dialysis Bundle. On the bone and mineral metabolism side, there may be discussions relating to the upcoming potential launch of PA-21, Vifor Fresenius Medical Care Renal Pharma's iron-based binder, which has submitted an NDA and the PDUFA date is December 1, 2013.
Rob Dubman is a director on the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources Group.
1. Keryx Biopharmceuticals Press Release November 5, 2013
2. Keryx Biopharmceuticals Press Release October 17, 2013
Note: ASN full abstracts can be viewed online at www.asn-online.org/education/kidneyweek/archives/