BN003644  23 de abril de 2007  12:01 HORALOCAL


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

   BASEL, Switzerland, April 23 /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 already 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 
that 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.

    About MIRCERA
    MIRCERA, a continuous erythropoietin 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 www.roche.com .

    (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 Guidelines

    (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

SOURCE  Roche
                                04/23/2007
    CONTACT:  Sheila Gies of Roche, +1-973-687-0188; Abenaa (Abby) Hayes 
of Weber Shandwick Worldwide, +1-212-445-8337, for Roche 
Web site:  http://www.roche.com 





BNED: NG

FONTE:    PR NEWSWIRE LATIN AMERICA
          CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
          BRASIL-NÉLIA GARCIA
TELS:     USA:1-201-360-6540/BRASIL:55-21-2132-8461
FAXES:    USA:1-201-360-6593/BRASIL:55-21-2132-8469
E-MAILS:  nelia_garcia@prnewswire.com.br mary_dleon@prnewswire.com

PALAVRA-CHAVE:  RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: ROCHE