MIRCERA Approved in European Union for Treatment of Anaemia Related to Chronic Kidney Disease

26.07.07 | 08:22 Uhr

Basel, Switzerland (ots/PRNewswire) -

- First Anti-Anaemia Product Offering Simple Once-Monthly
Maintenance Treatment

Roche announced today that the European Commission has approved
its innovative drug MIRCERA to treat anaemia associated with chronic
kidney disease (CKD). The approval of MIRCERA results in a single
marketing authorisation with unified labelling for EU countries which
is valid in all 27 EU member states. The Commission's decision
follows a Positive Opinion by the Committee for Medicinal Products
for Human Use (CHMP) in May 2007, recommending granting marketing
authorisation.

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 dosing.

"We have been a leader in anaemia management for nearly 20 years
and the approval of MIRCERA is a testament to the dedication of our
scientists to create a novel compound, as well as to the physicians
around the world who have participated in the largest clinical trial
program ever for a drug treating renal anaemia," said William M.
Burns, CEO of the Pharma Division at Roche. "MIRCERA has the
potential to deliver real clinical benefits in the management of
renal anaemia and provide the right frequency of treatment for all
CKD patients."

MIRCERA is the first ESA approved in the EU that offers a
convenient dosing schedule of once every two weeks to correct anaemia
in patients not previously treated. MIRCERA is also the first ESA to
directly convert all patients previously treated with any ESA to
once-monthly dosing. The safety and efficacy of MIRCERA in other
indications has not been established.

Once-monthly MIRCERA may enable health care professionals to spend
more time on other aspects of CKD patient care. In fact, data from a
study recently presented found that converting dialysis patients from
more frequently administered ESAs to once-monthly MIRCERA, could cut
nearly in half the annual time spent on anaemia management in a
dialysis centre(1).

Today's approval is based on efficacy and safety data from the
largest clinical program ever carried out for a drug treating anaemia
associated with CKD comprising 10 global studies involving more than
2,700 patients from 29 countries. MIRCERA is the only drug to have
compared itself in its registration program to three ESAs: epoetin
alfa, beta and darbepoetin alfa. Two correction and four maintenance
trials were conducted in Phase III. The aim of anaemia management is
to safely and smoothly increase low haemoglobin (Hb) levels to a
desired target range and then to maintain patients in this range to
avoid health complications.

The safety data base from clinical trials comprised 2,737 CKD
patients, including 1,789 patients treated with MIRCERA and 948 with
another ESA. Approximately 6% of patients treated with MIRCERA are
expected to experience adverse reactions. The most frequent reported
adverse reaction was hypertension. (2)

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).(3) 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. 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 %.(4)

About Roche

For more information please visit www.roche.com

For video content from Roche related to anaemia please log on to
www.thenewsmarket.com/roche, where you can order broadcast-standard
video to be received digitally or by tape. Registration and video is
free to the media.

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

All trademarks used or mentioned in this release are protected by
law.

References

(1) Saueressig U, Staff Time and Costs for Anaemia Management with
Erythropoietic Stimulating Agents in Patients on Haemodialysis,
ERA-EDTA 2007.

(2) European Public Assessment Report (EPAR), Scientific
Discussion. http://www.emea.europa.eu

(3) International Federation of Kidney Foundations.
http://www.ifkf.net/resources.php

(4) 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

Contact:
For further information please contact: Sheila Gies, Roche, Tel:
+1-973-235-4347, Mobile: +1-973-687-0188. Diane Lorton, Galliard
Healthcare, Tel: +44-207-663-2265, Mobile: +44-7717-531-823