Investor Update

Basel, 6 June 2005

New CERA year-long data show sustained and stable control of anemia in dialysis patients

Results achieved with once-monthly dosing

New data from a year-long study have shown that CERA, the first Continuous Erythropoietin Receptor Activator from Roche, provided sustained and stable control of hemoglobin levels with dosing intervals up to four weeks in dialysis patients who suffer from anemia.

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A combined analysis of this study and another, found that hemoglobin levels were maintained within the target range recommended by international treatment guidelines

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and were achieved irrespective of patients’ gender, race, age or diabetic status.

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These data were presented during the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) congress in Istanbul.

Increasing the numbers of patients who are maintained within target hemoglobin levels set by treatment guidelines is a major challenge and sometimes difficult for physicians to achieve in the treatment of anemia associated with chronic kidney disease (CKD). This control is important as hemoglobin levels are associated with lower mortality risk and reduced hospitalization as well as increases in patient quality of life and physical functioning

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Professor Francesco Locatelli, Scientific Director of A. Manzoni Hospital and Head of the Department of Nephrology in Lecco, Italy, who presented the data said “These data suggest that subcutaneous administration of CERA may achieve sustained and stable control of hemoglobin within guideline ranges and this is promising news for nephrologists since the most recent results of the European Survey on Anemia Management noted that a third of patients are not yet achieving a hemogloblin level greater than or equal to 11g/dL.”

Study Details
The data from this randomized, multicenter, dose-ranging phase II trial showed that administration of subcutaneous CERA provided a consistent haemoglobin response regardless of how frequently it was administered. Mean hemoglobin levels of 11.15 g/dL were achieved when CERA was administration once every four weeks; administration once every three weeks achieved a haemoglobin level of 11.18 g/dL; once a week dosing achieved a haemoglobin level of 11.33g/dL.

The analysis, which involved 61 patients, is the first to be presented from a 12-month extension period which continued from a phase II CERA study in dialysis patients with chronic renal anemia who were previously treated with subcutaneous epoetin.

About CERA
CERA is an innovative anti-anemia agent which stimulates red blood cell production at the receptors involved in a novel and continuous fashion. Roche has undertaken the largest phase II – III program ever for a drug treating renal anemia with 10 trials involving more than 2,700 patients. It is currently in phase III of its development in CKD and Roche aims to file it worldwide with health authorities in 2006.

About Anemia
Anemia affects up to 90% of patients with renal disease from patients with early stage CKD to patients with kidney failure requiring dialysis.  Anemia refers to when patients experience a lower than normal level of red blood cells or the hemoglobin in them.  Hemoglobin enables red blood cells to carry oxygen throughout the body and therefore, when the body is starved of the oxygen it requires, extreme fatigue sets in along with dizziness, pale skin and other serious clinical complications as the body works harder to carry the oxygen that remains.

Normally, when the body senses a decrease in red blood cells or a decrease in oxygen, more erythropoietin (a protein produced by the kidneys) is created. This protein stimulates the production of oxygen-carrying red blood cells in the bone marrow which raises the red blood cell count. When this natural mechanism is hindered (as in kidney disease patients), it is necessary to stimulate the receptors to produce red blood cells with agents such as CERA, which will be the first continuous erythropoietin receptor activator, which closely mimicks the body’s natural control of red blood cell production.

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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries 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 (www.roche.com).

Note to the editor:
A second CERA poster presented at the ERA-EDTA analysed the 12-month extension periods from two Phase II studies investigating intravenous (IV) or subcutaneous (SC) administration of CERA in dialysis patients previously treated with epoetin (and included the study reported on above by Prof. Locatelli).  It examined the impact of gender, age, race and diabetic status on mean haemoglobin levels over time and found no significant differences were observed between males or females, younger or older patients, Caucasians versus non-Caucasians or diabetic versus non-diabetic patients. The poster concluded that “these data indicate that CERA administered IV or SC maintains control of Hb levels within guideline ranges in dialysis patients.”

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1 Locatelli, Francesco et al. Subcutaneous CERA (Continuous Erythropoietin Receptor Activator) Maintains Hemoglobin Concentrations With Dosing Intervals Up To 4 Weeks In Dialysis Patients. ERA-EDTA 2005
2 Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Horl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S; European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 2004 May;19 Suppl 2:ii1-47
3 Dougherty Frank C et al. Adequate Hemoglobin Levels Are Maintained With Continuous Erythropoietin Receptor Activator (CERA) In Dialysis Patients Regardless of Gender, Age, Race, And Diabetic Status. ERA-EDTA, 2005.
4 Pisoni et al. Anemia Management and Outcomes From 12 Countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). AmJ Kidney Dis 44:94-111.