Basel, March 5, 2008

MIRCERA® successfully corrects anaemia with a smooth and steady rise in haemoglobin levels in line with current guidelines

The results of a large-scale study of patients with chronic kidney disease (CKD) who are not on dialysis, and who have never received a treatment for anaemia before, has found that MIRCERA given at an extended dosing interval once every two weeks effectively corrects anaemia. The authors of the ARCTOS study, published in the current issue of the Clinical Journal of the American Society of Nephrology¹ , say MIRCERA provides a smooth and steady increase in haemoglobin levels in accordance with current guidelines. Haemoglobin is a protein in red blood cells that carries oxygen throughout the body.

In the ARCTOS (Administration of C.E.R.A. in CKD Patients to Treat Anaemia with a Twice-Monthly Schedule) study, patients who received MIRCERA every two weeks achieved a 97.5% response, compared to those patients who received darbepoetin alfa more frequently, every week, who achieved a haemoglobin response of 96.3%. The study was 28 weeks in duration.

The study found that significantly fewer patients on MIRCERA experienced a haemoglobin value exceeding the upper ceiling of 13 g/dL set for the trial during the first eight weeks, 12.4% versus 33.5% of patients taking darbepoetin alfa. Indeed, for the whole study it was significant that 67.7% of patients taking MIRCERA and 80.6% of patients taking darbepoetin alfa experienced at least one haemoglobin value greater than 13 g/dL.

In addition, the study found that fewer patients treated with MIRCERA (2.5%) required one or more blood transfusions during the correction and evaluation periods compared with darbepoetin alfa (6.8%).

“Safety is of paramount importance in this population of patients who are often quite ill despite the fact that they have not yet progressed to dialysis. We were pleased to see that the most adverse events were mild to moderate; and few were considered treatment-related,” said Dr Iain Macdougall, Department of Renal Medicine, King’s College Hospital, London, and the lead investigator and author of the ARCTOS study, noting that patients were on average in their early to mid-60s, male, and suffering from illnesses such as diabetes, high blood pressure, or heart disease. “Although patients in clinical trials are often quite different from those in an unselected renal unit population, there is no reason to suggest that similar efficacy and safety results would not be expected with MIRCERA in routine clinical practice,” Dr. Macdougall added.

About the study

• ARCTOS was an open-label, randomized, multicenter, darbepoetin alfa-controlled, parallel-group Phase III correction study. It was one of two Phase III studies examining the correction of anaemia.
• A total of 324 patients from 12 countries were randomized 1:1 to receive subcutaneous MIRCERA once every two weeks or subcutaneous darbepoetin alfa once-weekly for 28 weeks. Thereafter, patients receiving MIRCERA were randomized to continue on it once every two weeks or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once-weekly or once every two weeks for the 24-week extension period.
• In all treatment groups haemoglobin levels remained stable during the extension period confirming that MIRCERA administered once-monthly effectively maintains stable haemoglobin levels in patients with CKD not on dialysis following correction with once every two week administration.
• Dosage was adjusted to achieve a haemoglobin (Hb) response (defined as: Hb >11 g/dL and an increase >1.0 g/dL versus baseline). Following achievement of response, dosage was adjusted to maintain haemoglobin within ±1.0 g/dL of response level and between 11-13 g/dL.

MIRCERA is the first continuous erythropoietin receptor activator indicated for the treatment of renal anaemia. It is approved in the EU, US and Switzerland to provide correction of anaemia with once every two week dosing and maintenance of stable haemoglobin levels with once-monthly use in all CKD patient types.  MIRCERA has a different receptor interaction and longer half-life which allows for sustained and predictable anaemia management.^2,3,4

Anaemia is a common and debilitating complication of CKD and its prevalence is increasing. A recent study showed that the rate of CKD has jumped from one in every 10 adults to about one in every 7 to 8⁵. Experts believe that this figure is likely to rise even more since obesity, diabetes and high blood pressure are all risk factors for CKD.⁶

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Additional information about the Roche Group is available on the Internet at www.roche.com.

Additional information about renal anaemia is available on the Internet at www.AnaemiaWorld.com

References
1) Macdougall I, et al. C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis: Results of a Randomized Clinical Trial. CJASN Mar 1, 2008; 3 (2) 337-347.
2) MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007
3) Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol. 2007;2:637-646
4) Jarsch M, Brandt M, Haselbeck A. Consumption of C.E.R.A. and epoetin beta in a cellular assay: UT-7 consumption model. Presented at American Society of Hematology (ASH) 48th Meeting, December 9–12, 2006, Orlando, FL
5) http://www.kidney.org/news/newsroom/newsitem.cfm?id=415 (accessed 11.24am GMT 28/01/08).
6) Agnani S., Vachharajani V. T., Gupta R., Atray N.K. and Vachharajani. T.J. Does treating obesity stabilize chronic kidney disease? 2005. BMC Nephrology 6:7doi:10.1186/1471-2369-6-7.