Mircera approved in European Union for treatment of anaemia related to chronic kidney disease

First anti-anaemia product offering simple once monthly maintenance treatment

BASEL, Switzerland | July 26, 2007 |
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 labeling 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
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.

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: www.AnaemiaWorld.com.

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

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.


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