First Study in Real-Life Setting Confirms That Once-Monthly Mircera Keeps Haemoglobin Levels Within a Tight Range

Basel, Switzerland, November 10 (ots/PRNewswire) -

- Results Demonstrate Effective and Simplified Approach to
Anaemia Management in Chronic Kidney Disease Patients on Dialysis

Interim study results from 90 renal centres in Germany confirm
for the first time that in a real-life setting Mircera(R) maintains
haemoglobin (Hb) levels within a narrow range when chronic kidney
disease (CKD) patients receiving dialysis are switched to
once-monthly Mircera from commonly used and frequently dosed
erythropoiesis-stimulating agents (ESAs)(1).

Multimedia News Release:
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The data, presented at the 41st Annual Meeting of the American
Society of Nephrology (ASN - http://www.asn-online.org/ ) in
Philadelphia, highlights Mircera's ability to keep Hb stable with
simple once-monthly dosing. Keeping Hb in a narrow target range has
become a hot issue for health authorities in the last year with
international guidelines recommending it be kept between 11-12 g/dL.
It is recognized that CKD patients are at a higher risk of death or
hospitalization when their Hb fluctuates outside the recommended
range (2). Keeping Hb within this narrow range however is a
challenge with many patients experiencing Hb fluctuations; a previous
study has shown that over a six month period only 6.5% of patients
(on dialysis) had Hb which stayed in a target range of 11-12.5g/dL
(3, 4).

Dr Danilo Fliser of the Saarland University Medical Centre,
Homburg, Germany and investigator for the MIRACEL study group who
presented the data said "Across the many centres involved in the
Miracel study physicians were administering four different ESAs with
different dosing schedules and it is gratifying to see that when we
simply switch to Mircera given once-a-month, we can effectively and
safely manage anaemia. I believe this may offer physicians and
nurses the opportunity to save time that can be redirected to
optimizing patient care."

About the study:

The MIRACEL study is a multi-centre single arm study involving
422 patients from 90 dialysis centres across Germany treated with
once-monthly Mircera. It is the first study using real-life data to
look at the impact of Hb stability following directly switching
dialysis patients from shorter-acting ESAs to once-monthly Mircera.

- The data presented were from the first 140 patients who had
been previously treated with either epoetin alfa, beta or delta or
darbepoetin alfa, administered three times a week (TIW) or once every
two weeks (Q2W) either intravenously or subcutaneously and who were
switched to once-monthly Mircera (QM) administered intravenously via
pre-filled syringes.

- During the study evaluation phase (month 7, 8 and 9) the
majority of patients (84%) had stable Hb levels (less than or equal
to, plus or minus 1 g/dL deviation from the individual mean).

- The median Mircera dose (125 micro g QM) was the same at the
start of the titration period and at the end of the evaluation
period.

- Mircera was generally well tolerated, with a safety profile
similar to that reported in all the Mircera Phase III studies. All
the patients had some underlying illnesses, with 30% having diabetes.

Managing CKD is very time consuming, with physicians handling
many other conditions in addition to anaemia, including high blood
pressure, high cholesterol, cardiovascular disease and diabetes. A
simplified approach to anaemia care could offer potential time saving
benefits for healthcare staff and more convenience for patients (5).
Modelling data presented at the ERA-EDTA conference in Barcelona last
year showed that it may be possible to cut nearly in half the annual
time spent on anaemia management in a dialysis centre by using a
once-monthly anaemia agent(6).

About Mircera:

Mircera, the first continuous erythropoietin receptor activator
indicated for the treatment of symptomatic anaemia in chronic kidney
disease, is now approved in 68 countries and launched in 49 including
the major EU markets Germany, the UK, Spain and France. It has a
different receptor interaction and longer half-life than other ESAs
which allows for sustained and predictable anaemia management(7, 8,
9). Mircera's method of administration is simple: it is the only ESA
approved in the EU to correct anaemia with an immediate
once-every-two-week treatment schedule in all CKD patient types
(those on or not on dialysis) with either an IV or SC dose. CKD
patients on dialysis or not, on any ESA, can then be directly
switched to a once-monthly maintenance schedule. This ability to
switch patients directly has the potential to simplify anaemia
management(6).

About Roche:

Information about the Roche Group is available on the Internet at
http://www.roche.com

Editor's Notes

For more information about the trial please go to:
http://www.roche-trials.com/patient/trials/trial110715.html

Additional information about renal anaemia is available on the
Internet at http://www.AnaemiaWorld.com and
http://www.lifeblood.anaemiaworld.com

The Mircera(R) logo and film clips about renal anaemia treatment
are available for media on the Internet at
http://www.thenewsmarket.com

References

(1) Fliser et al ASN 2008 abstract 553648. Once Monthly C.E.R.A.
Provides Stable Hb Levels in CKD Patients On Dialysis Following
Direct Switch From Short Acting ESAs.

(2) Gilbertson D. T. et al. Hemoglobin Level Variability:
Associations with Mortality. Clin J Am Soc Nephrol 3: 133-138, 2008

(3) Fishbane S. and Berns J. S. Kidney International. 2005;
68/3:1337.

(4) Ebben J. P, et al. J. Clin J Am Soc Nephrol. 2006; 1: 1205 -
1210.

(5) 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, 2008; 3 (2) 337-347

(6) Ulrich Saueressig, et al. Staff time and costs for anaemia
management with erythropoietic stimulating agents in patients on
haemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007

(7) MIRCERA(R) Summary of Product Characteristics. F. Hoffmann-La
Roche Ltd, 2007

(8) 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

(9) 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

For further information please contact:
Sheila Kolesaire at Roche Diane Lorton at Galliard
Tel: +973-235-4347 Tel: +44-(0)207-663-2265
Mobile: +973-687-0188 Mobile: +44-(0)7717-531-823

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Sheila Kolesaire at Roche,
Tel: +973-235-4347, Mobile: +973-687-0188; Diane Lorton at Galliard,
Tel: +44-(0)207-663-2265, Mobile: +44-(0)7717-531-823