Media Release

Basel, 23 October 2007

Roche Considering Legal Options In Patent Litigation Case

Roche announced today that a jury in the U.S. District Court in Massachusetts found in favour of Amgen in the patent infringement dispute relating to the Roche erythropoiesis-stimulating agent, MIRCERA. Roche is currently evaluating its legal options, including the possibility of an appeal.

Roche maintains its position that all of Amgen’s patents for epoetin asserted against Roche are invalid and not infringed, and believes the facts and the law support that position.

“The verdict is disappointing because in the end, it is U.S. patients with chronic kidney disease who lose. Amgen has had an extended monopoly for the last 20 years in the U.S. blocking new therapeutic options to treat anaemia from being introduced,” said William M. Burns, CEO of the Pharma Division at Roche.

MIRCERA is currently awaiting FDA approval which is expected on November 14th . MIRCERA was already approved in July in the European Union and in Switzerland and Norway in September. MIRCERA has been recently launched in Austria, Sweden, Germany and the UK. Studies with MIRCERA have shown that the treatment corrected and maintained haemogloblin levels as well as existing ESAs but with fewer injections than currently available erythropoiesis-stimulating agents (ESAs) ¹. One of the pivotal studies from its Phase III program was just published in The Lancet ².

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.

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1) In the EU, for patients not currently treated with an erythropoiesis stimulating agent (ESA), the recommended starting dose is 0.6 microgram/kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase the haemoglobin to greater than 11 g/dl (6.83 mmol/l). Patients currently treated with an ESA can be converted to MIRCERA administered once a month as a single intravenous or subcutaneous injection. The starting dose of methoxy polyethylene glycol-epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution. Summary of Product Characteristics for MIRCERA in the EU, www.emea.europa.eu. Darbepoetin alfa in the correction phase, the initial dose by subcutaneous or intravenous administration is 0.45 μg/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, an initial dose of 0.75 μg/kg may be administered subcutaneously as a single injection once every two weeks. In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks. In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. In the US, darbepoetin alfa The recommended starting dose of Aranesp® for the correction of anemia in adult CRF patients is 0.45 mcg/kg body weight, administered as a single IV or SC injection once weekly. Because of individual variability, doses should be titrated to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for RBC transfusion and not to exceed 12 g/dL
The use of Aranesp® in pediatric CRF patients as the initial treatment to correct anemia has not been studied. In the maintenance phase Aranesp® dosage should be adjusted to maintain the lowest hemoglobin level sufficient to avoid the need for RBC transfusion and not to exceed 12 g/dL. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient (see Dose Adjustment). For many patients, the appropriate maintenance dose will be lower than the starting dose. Predialysis patients, in particular, may require lower maintenance doses. Some patients have been treated successfully with a SC dose of Aranesp® administered once every 2 weeks.

2) Levin NW. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomized non-inferiority trial (MAXIMA). The Lancet; 370: 1415-1421.