Velphoro(R) (PA21) receives US FDA approval GLATTBRUGG,

GLATTBRUGG, Switzerland, Nov. 28, 2013 (GLOBE NEWSWIRE) -- Velphoro ^® (PA21) receives US FDA approval for the treatment of hyperphosphatemia in Chronic Kidney Disease Patients on dialysis

Velphoro ^® (sucroferric oxyhydroxide) has received US Food and Drug Administration (FDA) approval for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Velphoro ^® will be launched in the US by Fresenius Medical Care North America in 2014.

Velphoro ^® (previously known as PA21) is an iron-based, calcium-free, chewable phosphate binder. US approval was based on a pivotal Phase III study, which met its primary and secondary endpoints. The study demonstrated that Velphoro ^® successfully controls hyperphosphatemia with fewer pills than sevelamer carbonate, the current standard of care in patients with CKD on dialysis ¹ . The average daily dose to control hyperphosphatemia was 3.3 pills per day after 52 weeks.

Velphoro ^® was developed by Vifor Pharma. In 2011, all rights were transferred to Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care. In the US, Velphoro ^® will be marketed by Fresenius Medical Care North America, a company with a strong marketing and sales organization, and expertise in dialysis care. The active ingredient of Velphoro ^® is produced by Vifor Pharma in Switzerland.

Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis. Most dialysis patients are treated with phosphate binders. However, despite the availability of a number of different phosphate binders, up to 50% of patients - depending on the region - are still unable to achieve and maintain their target serum phosphorus levels ² . In some patients, non-compliance due to the high pill burden and poor tolerability appear to be key factors in the lack of control of serum phosphorus levels ^3,4 . On average, dialysis patients take approximately 19 pills per day with phosphate binders ⁵ comprising approximately 50% of the total daily pill burden. The recommended starting dose of Velphoro ^® is 3 tablets per day (1 tablet per meal).

Full results from the pivotal Phase III study involving more than 1,000 patients were presented at both the 50 ^th ERA-EDTA (European Renal Association - European Dialysis and Transplant Association) Congress in Istanbul, Turkey, in May 2013, and the American Society of Nephrology (ASN) Kidney Week in Atlanta, Georgia, in November 2013. Velphoro ^® was shown to be a potent phosphate binder, with lower pill burden and a good safety profile.

Based on these data, Vifor Fresenius Medical Care Renal Pharma believes that Velphoro ^® offers a new and effective therapeutic option for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

The regulatory processes in Europe, Switzerland and Singapore are ongoing and decisions are expected in the first half 2014. Further submissions for approval are being prepared.

For further information, please contact:

Media Relations:
Beatrix Benz, Head of Global Communications
Tel.: +41 58 851 80 16
E-mail: communications@viforpharma.com

Vifor Fresenius Medical Care Renal Pharma Ltd. , a common company of Galenica and Fresenius Medical Care develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.

Velphoro ^® / PA21 is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches. Each tablet of Velphoro ^® contains the equivalent of 500mg of iron. When taken with meals, Velphoro ^® adsorbs the dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood. The adsorbed phosphate is subsequently eliminated through the faeces.

The Velphoro ^® Phase II clinical trial met both its primary and secondary endpoints. The serum phosphorus lowering efficacy of the two lowest active doses was numerically comparable to 4.8g/day sevelamer hydrochloride. Velphoro ^® was also well tolerated, with a comparable overall safety and tolerability profile.

The Phase III trial was an open-label, randomised, active controlled, parallel group study to investigate the safety and efficacy of Velphoro ^® compared to sevelamer carbonate , followed by a randomized comparison of Velphoro ^® maintenance dose versus Velphoro ^® inactive low-dose in dialysis patients with hyperphosphatemia.

During the Phase III study no clinically meaningful changes for vitamins (A, D, E and K) were observed on Velphoro ^® . A sub-analysis is being conducted on patients who received oral vitamin D analogues in the study, in an effort to modify the package insert statement that "Velphoro ^® should not be prescribed with oral vitamin D analogues" which was based on in-vitro data. Of the dialysis patients in the US receiving vitamin D for the management of bone and mineral disease, 82% are treated with intravenous formulation ⁶ , which is approved for use with Velphoro ^® .

Velphoro ^® is developed in collaboration with Fresenius Medical Care ( www.fmc-ag.com ). It is also currently undergoing Phase III clinical development in Japan by Kissei Pharmaceuticals Co., Ltd.

References

1. Floege J et al. Efficacy and safety of an iron-based phosphate binder, PA21, in hyperphosphatemic CKD patients on dialysis; Poster SA-PO1103, ASN congress 2012, San Diego.
2. US-DOPPS Practice Monitor, October 2013; http://www.dopps.org/DPM/
3. Tonelli M, et al. Oral Phosphate Binders in Patients with Kidney Failure; NEJM 2010;362:1312-1324.
4. Wang S et al. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis; Nephrol Dial Transplant 2013 Sep 5. [Epub ahead of print]
5. Chiu YW, et al. Pill Burden, Adherence, Hyperphosphatemia, and Quality of Life in Maintenance Dialysis Patients; Clin J Am Soc Nephrol 2009;4(6):1089-1096
6. BioTrends Research Group, Treatment Trends, Nephrology (US) Q3, 2013

Indication US FDA approval:

Velphoro ^® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Important safety information:

• Velphoro must be administered with meals. Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed.

• Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.
   
• In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).
   
• Velphoro can be administered concomitantly with ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metformin, metoprolol, nifedipine, omeprazole, quinidine and warfarin. Take alendronate and doxycycline at least 1 hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine and oral vitamin D analogs. 

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