Pivotal MIRCERA Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Four Weeks

Geschrieben am 19-10-2007

Basel, Switzerland (ots/PRNewswire) -

- MAXIMA Findings in the Lancet Affirm Ability to Maintain
Haemoglobin Levels With Less Frequent Dosing

A pivotal study published today in the Lancet has shown that
dialysis patients can be effectively switched from frequently dosed
anaemia drugs to an innovative new anaemia treatment, MIRCERA, that
can be administered once a month.(1)

The MAXIMA (Maintenance of Haemoglobin Excels in Intravenous
Administration of C.E.R.A.) study is the first randomised,
comparative study to investigate the direct conversion of dialysis
patients with chronic kidney disease from treatment with
erythropoiesis-stimulating agents (ESA) given one to three times a
week to IV MIRCERA administered once every four weeks. The results
demonstrated that MIRCERA maintains haemoglobin (Hb) concentrations
within the target range as effectively as ESAs epoetin alfa or beta
which must be given on a much more frequent basis.

"Our findings demonstrate that MIRCERA can be administered once
every four weeks in haemodialysis patients without sacrificing
haemoglobin stability," said Nathan Levin, Medical and Research
Director, Renal Research Institute, New York, New York and the lead
author of the publication. "We note in The Lancet that these results
should be generalisable to the maintenance haemodialysis population
and that we believe this drug should be an option to epoetin for
simplified anaemia management."

Simplified Anaemia Management A Potential Strategy To Decrease
Rate Of Medication Errors

The publication notes that conventional ESAs having short
half-lives necessitate frequent administration to maintain stable Hb
concentrations. Frequent administration, dose changes, and close
monitoring of Hb concentrations complicate management of anaemia. The
authors comment that "errors with medication errors occur at an
unacceptably high rate of 45%. Extrapolation to about 246 000
haemodialysis patients in the USA, suggests that 111 000 dose errors
could happen every month." The authors add that treatment with
MIRCERA every four weeks would need only 13 doses per year, compared
with 52-156 doses with conventional epoetin and would therefore
"allow fewer opportunities for error."

MAXIMA Study Details

The MAXIMA study randomised 673 adult patients with stable chronic
renal anaemia on dialysis therapy and IV maintenance epoetin at 91
centres in eight countries. Most patients were from North America
(USA - 68%; Canada - 11%) and Europe (21%). The study compared two
administration intervals of IV MIRCERA (once every two weeks or once
every four weeks) with continued IV epoetin treatment (one to
three-times a week) in patients with chronic renal anaemia. After a
run-in period, patients were randomly assigned to either of the
MIRCERA arms or to continue epoetin alfa or beta at their current
dose and administration interval. Patients randomized to MIRCERA
received a starting dose based on the previous weekly dose of

In contrast to previous studies in which dialysis patients were
converted from IV epoetin using sequential increases in dosing
intervals, most patients in MAXIMA were converted directly from a
predominantly three-times-a-week regimen of epoetin (87% of patients)
to IV MIRCERA administered once every four weeks.

The MAXIMA results showed:

- Minute changes in Hb levels throughout the duration of the study
(mean changes from the baseline to the evaluation periods were -0.71,
-0.25, and -0.75 g/L in the MIRCERA once every two weeks; MIRCERA
once every four weeks and epoetin groups, respectively), illustrating
that the primary efficacy parameter (mean change in Hb level between
baseline and evaluation periods) was met.

- For the secondary analysis, the proportion of patients
maintaining a mean Hb within plus or minus 10 g/L of baseline was
68%, 68%, and 67% in the MIRCERA once every two weeks and MIRCERA
once every four weeks and epoetin groups, respectively.

- A similar incidence of adverse events across all treatment arms
with the most frequent adverse events mild to moderate and had a
distribution typical for this patient population.


MIRCERA, a continuous erythropoietin receptor activator, has a
different activity at the receptor level involved in stimulating red
blood cell production which more closely mimics the body's
physiologic processes. This is believed to be instrumental in
delivering predictable and stable haemoglobin levels with
once-monthly maintenance dosing.

MIRCERA was approved in the EU in July and is the first ESA that
offers a convenient dosing schedule of once every two weeks to
correct anaemia in all CKD patients types not previously treated.
MIRCERA is also the first ESA in the EU approved to directly convert
all CKD patients types previously treated with any ESA to
once-monthly dosing. The safety and efficacy of MIRCERA in other
indications has not been established. MIRCERA has now been launched
in Austria, Sweden, Germany and the UK, and was recently approved in
Switzerland and Norway.

About CKD and anaemia

Globally more than 500 million people, approximately one in 10 of
the general population, have some degree of chronic kidney disease
(CKD).(2) People with CKD experience a progressive deterioration in
kidney function, often over a period of years until renal replacement
therapy is needed. Patients whose kidneys are failing are unable to
secrete erythropoietin, a protein that is produced by the kidneys and
which stimulates the production of red blood cells in the bone
marrow. ESAs are given to replace what the body can no longer
produce. Renal anaemia is a common and significant complication of
CKD and is responsible for a significant proportion of the
distressing and disabling symptoms that affect the daily health and
quality of life of patients with CKD. Anaemia is also instrumental in
the development of potentially fatal cardiovascular disease in
patients with CKD; the prevalence of cardiovascular illness in all
populations with kidney disease (CKD not on dialysis, on dialysis and
post-transplant) is approximately 35-40 %.(3)

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.


(1) "Patients currently treated with an ESA can be converted to
MIRCERA administered once a month as a single intravenous or
subcutaneous injection" in the EU. See Summary of Product
Characteristics (SMPC) @ http://www.emeaeuropa.eu for EU label.

(2) International Federation of Kidney Foundations.

(3) Levin A. The role of anaemia in the genesis of cardiac
abnormalities in patients with chronic kidney disease. Nephrol Dial
Transplant 2002; 17:207-210.

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

For further information please contact: Sheila Gies, Roche, Mobile:
+1-973-687-0188. Diane Lorton, Galliard Healthcare, Mobile:


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