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Mircera Effective in Stabilising Haemoglobin Levels in Elderly,Patients With Kidney Disease on Dialysis

Findings Illustrate Role of Innovative New Treatment in Population Most Affected by Chronic Kidney Disease

BASEL, Switzerland, April 23, 2007 /PRNewswire/ -- A new Roche Phase III analysis shows once-monthly MIRCERA, a continuous erythropoietin receptor activator, effectively treats renal anaemia in one of the fastest growing groups of patients with chronic kidney disease (CKD) -- elderly patients who are on dialysis. In this analysis, MIRCERA treatment kept Hb levels stable, deviating less than 0.5 g/dL from start of the trial in patients over age 65 with a simplified dosing schedule. The data were presented today at the World Congress of Nephrology (WCN) in Rio de Janeiro.

"These results show that MIRCERA safely and effectively treated a group of kidney disease patients who represent the 'face' of dialysis and also have the poorest prognosis," said Marializa Bernardo M.D., Southwest Nephrology Associates, Houston, Texas, who presented the data. "Elderly dialysis patients are fragile because they suffer from a range of coexisting diseases along renal anaemia that worsen their health, impact their quality of life and increase their risk of hospitalization and death. This analysis shows that those elderly patients on dialysis who were directly converted from treatment given up to three times a week to MIRCERA twice monthly or once monthly maintained stable haemoglobin levels."

The prevalence of CKD patients on dialysis is projected to grow 7 per cent per year and it is estimated that by 2010, there will be over 2 million people worldwide on dialysis.(i)

These results, based on a pooled analysis from two large MIRCERA Phase III maintenance studies, evaluated patients age 18 and older that are representative of the real world dialysis population. The mean age of patients included in the analysis was 60 years of age (however more than 40 per cent of patients were over age 65) and patients had a lready been on dialysis from 33 to 40 months. The study also found a higher transfusion requirement in elderly patients. A significant number of patients entering the study suffered from diabetes (more than 35 per cent) and arterial hypertension (more than 90 per cent) -- two of the main causes of CKD and among the most common co-morbid conditions in CKD patients.

The results showed that intravenous (IV) and subcutaneous (SC) MIRCERA maintained stable Hb levels in dialysis patients over and under 65 years of age who were successfully switched from the frequently administered agents, epoetin alfa and beta. The study investigators also noted:

-- Minimal changes from baseline to evaluation in mean Hb levels in patients less than or equal to 65 and >65 years (-0.18 vs -0.34 g/dL), meaning that the elderly can be treated with confidence.

-- Minimal mean Hb changes from baseline to evaluation in male and female patients treated with MIRCERA (-0.21 vs -0.30 g/dL).

MIRCERA treatment was well tolerated, with a safety profile characteristic of the patient population.

"With more elderly people needing dialysis treatment, doctors will need effective medications that can improve the way we manage renal anaemia. These findings underscore the value of MIRCERA in meeting a goal of anaemia management, namely haemoglobin stability," said Dr. Elias David Neto, Centro de Nefrologia e Transplante Renal, University of Sao Paulo, Sao Paulo, Brazil.

Bearing the Burden of Chronic Kidney Disease: The Prevalence of Dialysis in an Aging Population

Dialysis is the only treatment option for end stage renal disease patients who are either waiting for or not a candidate for a renal transplant. The number of people over the age of 65 with end stage renal disease is on the rise because of an aging population and the diabetes epidemic.(ii),(iii) In fact, more than 50 percent of the people on dialysis are over 60 years of age.(iv) Further, it is known t hat at the time patients reach ESRD, more than 50 per cent of patients have congestive heart failure, heart disease, and diabetes, and more than 80 per cent have hypertension.(v)

These patients bear a significant disease burden that impacts their long-term prognosis. The United States Renal Data System indicates that elderly dialysis patients are:

-- Expected to live ten years less than their healthy counterparts of the same age

    -- More likely to have heart disease than healthy patients

    -- More likely to have strokes than their healthy counterparts

    -- At increased risk for death from cardiovascular events

About the WCN Clinical Analysis

Today's analysis was based on data from two trials (MAXIMA and PROTOS) which were part of the largest clinical development program ever for the treatment of renal anaemia. In these two trials 1,245 dialysis patients were randomized to remain on their current epoetin treatment administered up to three times or week or to be switched (converted) directly to MIRCERA administered IV or SC once every two weeks or once every four weeks.

Initial findings from the MIRCERA Phase III program, which included four conversion/maintenance and two initiation/correction studies, were presented at the European Renal Association-European Dialysis and Transplant Association congress in June 2006 and at the American Society of Nephrology's Renal Week in November 2006. The maintenance study results showed that for the first time, patients with CKD on dialysis treated with short-acting and frequently administered epoetin anti-anaemia drugs can be switched successfully and directly to a once-monthly treatment. In the correction studies, the findings showed CKD patients on dialysis, as well as those not on dialysis who need correction of renal anaemia, can be successfully treated with MIRCERA on a simple twice-monthly dosing schedule.


MIRCERA, a continuous erythropo ietin receptor activator, is the first of a new class of long-acting chemically synthesized erythropoiesis-stimulating agents (ESAs) having reached regulatory review that could represent a significant advance in renal anaemia management. It is in development for the treatment of renal anaemia in chronic kidney disease (CKD) patients on dialysis or not on dialysis. The largest clinical program ever undertaken in renal anaemia has shown that MIRCERA provides predictable and stable haemoglobin management for all CKD patients with up to once-monthly dosing. This innovative agent is currently being reviewed by health authorities in the EU, USA, Switzerland, Canada and Australia.

Notes to Editors:

1. Renal anaemia is caused when the kidneys fail to stimulate the production of red blood cells, which transport the oxygen-carrying protein, haemoglobin, throughout the body. Renal anaemia is present in the early stages of CKD and becomes increasingly common and more severe and more common as the disease progresses. In fact, as patients reach end-stage renal disease, more than 90 per cent(vi)(vii), (viii), of them will be affected by renal anaemia.

2. Current European (EBPG) and US (NKF- K/DOQI) guidelines recommend doctors target specific ranges in treating renal anaemia.

About Roche

For more information, visit

(i) Lysaght MJ., Maintenance dialysis population dynamics: current trends and long-term implications. Journal of the American Society of Nephrology. 2002. 13: S37-S40.

(ii) Medscape Medical News "Care of ESRD Patients Could be Better: New Approaches Warranted" February 21, 2007

(iii) Collins et al, Excerpts from the Unites States Renal Data System 2004 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. American Journal of Kidney Diseases. Vol 45, No 1, Suppl 1, January 2005

    (iv) European Best Practice Guideline

    (v) United States Renal Data System, 2006

(vi) Obrador et al., Trends in anemia at initiation of dialysis in the United States. Kidney International. 60:1875-1884, 2001

(vii) Hsu C.Y., Epidemiology of anemia associated with chronic renal insufficiency. Current Opinion in Nephrology and Hypertension. 2002; 11:337-341

(viii) Hsu C.Y., et al Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: Results from the Third National Health and Nutrition Examination Survey. Journal of the American Society of Nephrology. 2002; 13:504-510

CONTACT: Sheila Gies of Roche, +1-973-687-0188; Abenaa (Abby) Hayes ofWeber Shandwick Worldwide, +1-212-445-8337, for Roche

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