Innovative New Anaemia Drug MIRCERA Demonstrates Ability to Maintain Tight Haemoglobin Levels at Once Monthly Dosing in Dialysis Patients With Chronic Kidney Disease

Geschrieben am 07-06-2007

Basel, Switzerland (ots/PRNewswire) -

- First Publication of Phase III Data in the Clinical Journal of
the American Society of Nephrology

Results from a multi-centre renal anaemia study show that
switching patients directly from frequent doses of epoetin therapies
(epoetin alfa or beta administered one to three times weekly) to
extended dosing intervals of MIRCERA (up to once a month) is
effective for maintaining tight, sustained, and predictable control
of haemoglobin levels within a target range in dialysis patients with
chronic kidney disease (CKD).

The results of the first large-scale study to demonstrate direct
conversion of dialysis patients to monthly subcutaneous MIRCERA, will
be published in the July edition of the Clinical Journal of the
American Society of Nephrology (CJASN).(1) This is the first time a
study has shown direct conversion to a monthly administration; a
previous attempt with another erythropoiesis stimulating agent (ESA)
showed that it requires a stepwise approach to extended dosing
depending on the patient's response each time the dosing interval is

"In an environment where government bodies and guidelines are
increasingly requiring physicians to maintain patients in a narrow
haemoglobin target range, it's encouraging to see that MIRCERA, the
first continuous erythropoietin receptor activator, can provide
stable haemoglobin levels with the added benefit of once-monthly
dosing," said Prof. Wladyslaw Sulowicz, Collegium Medicum,
Jagiellonian University, Krakow, Poland, the lead investigator of the

The PROTOS (Patients Receiving C.E.R.A. Once a month for the
maintenance Of Stable haemoglobin) study included 572 dialysis
patients from the EU, US, Asia Pacific and South America. PROTOS was
a three-arm, controlled, open-label, randomized, Phase III study
designed to compare the efficacy and tolerability of two dosing
intervals (one and twice a month) of subcutaneous MIRCERA with that
of patients continuing their subcutaneous epoetin therapy one to
three times a week for the maintenance treatment of anaemia.

The study results showed:

- Minute changes in patients' haemoglobin (Hb) levels from
baseline to evaluation (-0.131g/dL for MIRCERA once monthly,
0.032g/dL for MIRCERA twice monthly and -0.109g/dL for epoetin)
showing that patients can be converted directly to therapy given up
to once a month without compromising stability.

- The proportion of patients maintaining stable Hb within the
range 10-13.5 g/dL during the evaluation period was similarly high in
all groups (88.1% for MIRCERA once monthly, 91.5% for MIRCERA twice
monthly and 88.1% for epoetin).

- The proportions of patients with mean Hb within plus or minus
1.0 g/dL of baseline values during the evaluation period were 66.1%,
75.6%, and 72.2% respectively in the MIRCERA once monthly, MIRCERA
twice monthly and epoetin groups.

- MIRCERA is well tolerated with a safety profile that is
characteristic of the patient population under study. The most
commonly reported adverse events (AEs) were hypertension, procedural
hypotension (induced by dialysis), nasopharyngitis, headache, and
diarrhoea. Most events were mild or moderate in intensity and
distributed evenly across the three treatment groups.

The authors noted that mean Hb levels during the evaluation period
for patients receiving MIRCERA were within current guideline ranges
and the difference in Hb level between baseline and evaluation was
within plus or minus0.15 g/dL in both MIRCERA groups. "Hence, the
results of this study show that switching directly from one to three
times weekly administration of epoetin alfa or beta to C.E.R.A. at
extended dosing intervals is effective for maintaining tight,
sustained, and predictable control of Hb levels within target range
in this patient population. Moreover, mean Hb values remained stable
during the evaluation and long- term safety periods, demonstrating
maintenance of Hb control over time."

"We proposed in the publication that the ability of MIRCERA to
maintain tight haemoglobin levels with once-monthly administration
should improve anaemia management in CKD by alleviating the
increasing workload of healthcare professionals," said Prof.
Sulowicz, adding "Once-monthly administration will also save up to
144 injections per patient per year compared with three-times weekly


MIRCERA, is a continuous erythropoietin receptor activator that
shows a different activity at the receptor level characterized by a
slower association to and faster dissociation from the receptor, a
reduced specific activity in vitro with an increased activity in
vivo, as well as an increased half-life, in contrast to
erythropoietin. MIRCERA is the only drug to have compared itself in
its registration program to three ESAs: epoetin alfa, beta and
darbepoetin alfa. In May, MIRCERA received an approvable letter from
the US FDA and a positive opinion from the European Committee for
Medicinal Products for Human Use (CHMP) recommending a marketing
authorisation be granted in the EU.

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. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet at www.roche.com.

Note to Editor on Study:

After a 4-week baseline period, when patients continued to receive
epoetin, those eligible were randomized (1:1:1) to receive
subcutaneous MIRCERA once monthly, subcutaneous MIRCERA twice monthly
or to continue receiving subcutaneous epoetin at their current dose
and administration interval. Patients were randomly assigned to study
treatment via a central randomization centre with stratification by
geographical region.

Starting doses of MIRCERA were based on the epoetin dose received
during the week preceding randomization. The study consisted of a
dose titration period during the first 28 weeks after the initial
dose of study drug (week 1-28), followed by an 8-week efficacy
evaluation period (week 29-36), and a 16-week long-term safety follow
up (week 37-52). In the titration and evaluation periods, the dose of
MIRCERA was adjusted to maintain patients' Hb within a range of plus
or minus1.0 g/dL of their baseline Hb and between 10 and 13.5 g/dL.
During the long-term safety observation period, the dose of MIRCERA
was adjusted to maintain Hb levels within a range of 11 to 13 g/dL.

(1)This publication is now available through the on-line E-Press
version at www.cjasn.asnjournals.org

Additional information about renal anaemia is available on the
Internet at www.AnaemiaWorld.com.

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

For further information, please contact: Sheila Gies, Roche, Phone:
+1-973-235-4347; Nicole Symon, Weber Shandwick Worldwide, Phone:


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