Investor Update
Basel, 25 June 2007
Once-monthly
Mircera keeps haemoglobin stable
in high-risk kidney disease patients with diabetes
or heart disease
An analysis of two large-scale Phase
III maintenance studies on Mircera has highlighted that two high risk patient populations - dialysis
patients with diabetes and/or coronary artery disease - consistently and safely maintained their haemoglobin
(Hb) levels at target levels after direct conversion from more frequently administered epoetin to once-monthly
Mircera, a continuous erythropoietin receptor activator. This is significant outcome as erratic Hb levels
have a serious negative impact in these high risk patients. In addition, being able to effectively control
Hb levels with a convenient once-monthly treatment is a further positive outcome.
"Mircera
was effective in maintaining haemoglobin levels irrespective of the presence or absence of diabetes
or coronary artery disease," said Dr Johannes Mann from the KfH Nierenzentrum in Munich, German
who presented the new data to delegates at the congress. "This is important news for us since we
often see dialysis patients with multiple health conditions where it is critical not to expose them
to unnecessary or additional health risks associated with fluctuating haemoglobin levels."
These
award-winning data* were presented for the first time today at the 44th European Renal Association-European
Dialysis and Transplant Association (ERA-EDTA) Congress in Barcelona.1 The
investigators set out to examine Hb stability with Mircera administered once monthly in patients with
or without diabetes and coronary artery disease (CAD) (history of angina, myocardial infarction, coronary
angioplasty or coronary artery bypass grafting), which represents populations with a poor prognosis.
Thirty-five per cent of Mircera patients in the study had diabetes and 31% had CAD.
Diabetes
is the leading cause of end stage renal disease in the western world2,3 and
cardiovascular disease is the major cause of death in patients with diabetes4;
both are frequently present in CKD patients on dialysis either individually or together.
The
Analysis
Adult patients (832) with stable baseline Hb were randomised in two 52-week,
Phase III multi-centre studies (MAXIMA and PROTOS) to receive either IV or SC Mircera once monthly (415
patients) or to continue with IV or SC epoetin (417 patients) administered once to three times a week.
The dose was adjusted no more frequently than once every four weeks to maintain Hb within +/- 1 g/dL
of their original baseline value and within a range of 10 - 13.5 g/dL. The change in Hb was investigated
in the presence and absence of CAD or diabetes.
Results
- Mean baseline haemoglobin levels in the Mircera group with and without diabetes were 11.8 and 11.7 g/dL and with and without coronary artery disease were 11.7 and 11.8 g/dL.
- During the evaluation period, stable Hb levels were maintained irrespective of the presence or absence of CAD or diabetes.
- Mircera had a similar adverse event profile in patients with and without diabetes or coronary artery disease; adverse events were typical of the patient populations.
About Mircera
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. Mircera is not marketed yet, but in May it 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 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.
Additional
information about renal anaemia is available on the Internet at www.AnaemiaWorld.com.
*This
abstract, which was granted an oral presentation, was one of three Mircera abstracts that received the
honour of being among the top eight best abstracts received by the congress this year.
All
trademarks used or mentioned in this release are legally protected.
1)
Johannes Mann et al. C.E.R.A. provides stable haemoglobin (Hb) levels in CKD patients
on dialysis with and without coronary artery disease (CAD) or diabetes mellitus (DM) when administered
once monthly .44th ERA-EDTA Barcelona 2007
2) National Kidney Foundation website: Diabetes
and Kidney Disease, www.kidney.org
3) Stevens PE, et al Anaemia in patients with diabetes:
unrecognised, undetected and untreated? Cur Med Res Opin 2003; 19 (5) 395-401.
4) Levin
A. et al. Cardiovascular disease and the kidney; tracking a killer in chronic kidney disease. Postgrad
Medicine 2002; 111: 453-60.