MIRCERA(R) Successfully Corrects Anaemia With a Smooth and Steady Rise in Haemoglobin Levels in Line With Current Guidelines

Basel, Switzerland (ots/PRNewswire) - 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 Nephrology(1), 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(greater than or equal to)11 g/dL and an increase
(greater than or equal to)1.0 g/dL versus baseline). Following
achievement of response, dosage was adjusted to maintain haemoglobin
within (plus or minus)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
8(5). 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 http://www.roche.com.

Additional information about renal anaemia is available on the
Internet at http://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.

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

Contact:
For further information please contact: Sheila Kolesaire at Roche,
Tel: +1-973-235-4347, Mobile: +1-973-687-0188; Diane Lorton at
Galliard, Tel: +44(0)207-663-2265, Mobile: +44(0)7717-531-823; Dr.
Iain Macdougall, Tel: +44-207-346-6234.


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