Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is a strategic partnership between Vifor Pharma and Fresenius Medical Care (FMC), specializing in therapies to treat renal disorders. VFMCRP is rapidly growing its renal portfolio, combining the strengths of its two key shareholders, Vifor Pharma, a pharmaceutical company with a long-standing history in iron deficiency therapy, and FMC, one of the world’s leading dialysis service providers. Iron replacement products such as Venofer, and Ferinject/Injectafer, cemented Vifor Pharma as the leader in iron deficiency treatment. These products are often prescribed as first- or second-line treatment for renal anemia, a common complication of chronic kidney disease (CKD) managed through the use of iron supplements and premium priced erythropoietin stimulating agents (ESAs). Historically, Venofer has dominated the dialysis market in Europe and the United States because FMC gained the distribution rights to this agent and granted Venofer preferred status in many of its centers. VFMCRP’s CKD portfolio was further expanded in 2013 with the inclusion of Velphoro, an iron-based phosphate binder to treat hyperphosphatemia in patients with CKD on dialysis. The company is also expected to acquire other renal medications commercialized by FMC, including the phosphate binders Osvaren and Phosphosorb1. Recently we have seen VFMCRP broaden its position as a leading player in renal disorders with the help of its own sales affiliates and Galenica, the parent company of Vifor Pharma. A few such activities are listed below.
Galenica to acquire Relypsa and its hyperkalemia agent Veltassa2: On July 21 2016, Galenica announced their intent to acquire Relypsa. Kidneys play a major role in maintaining serum potassium levels and hyperkalemia occurs when there is a defect in at least one of the mechanisms that maintain this balance, most commonly when excretion of potassium by the kidneys is decreased. Due to ZS-9’s recent setback3, as of now, Veltassa has sole control of the U.S. hyperkalemia market and has more time than initially anticipated to take advantage of its first-to-market status. Relypsa’s operations are expected to fold into Galenica’s VFMCRP unit4.
Vifor Pharma win rights to commercialize Retacrit5: On May 24 2016, Vifor Pharma expanded its ESA portfolio with the licensing of commercialization rights to Pfizer’s Retacrit. Retacrit, a proposed epoetin zeta biosimilar, is under review for the treatment of anemia associated with CKD and renal failure. Once approved, Vifor Pharma will be positioned to offer this short-acting ESA to the U.S. dialysis market.
VFMCRP and OPKO Health enter into agreement for OPKO’s Rayaldee6: On May 9 2016, VFMCRP obtained rights to commercialize Rayaldee in Europe, Canada and other international markets for the treatment of secondary hyperparathyroidism (SHPT) in patients with CKD and vitamin D insufficiency. Both parties will collaborate to develop and commercialize Rayaldee for the treatment of SHPT in dialysis patients, and OPKO has granted VFMCRP an option to acquire rights to the U.S. market for treatment of dialysis patients.
Galenica teams up with FMC for Mircera7: On May 28, 2015 Roche entered into an exclusive license agreement with Galenica for the commercialization of Mircera in the U.S. In addition, Galenica entered into an exclusive supply agreement with Fresenius Medical Care North America (FMCNA) under which, Galenica would supply Mircera to FMCNA for use within its dialysis facilities. Mircera, a long-acting ESA, generated sales of $441M for Roche outside the U.S. last year.
So, is VFMCRP setting itself up as the leading care provider in renal disorders? Given the flurry of VFMCRP’s recent collaborations focused on renal disorders to put together a comprehensive portfolio covering essential renal therapeutic areas such as renal anemia management, hyperkalemia, hyperphosphatemia, and SHPT, it sure looks that way.