Roche announced that a jury in the US 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 US patients with chronic kidney disease who lose. Amgen has had an extended monopoly for the last 20 years in the US blocking new therapeutic options to treat anaemia from being introduced," said William M. Burns, CEO, pharma division, Roche.

Mircera is currently awaiting FDA approval which is expected on November 14 . 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 haemoglobin levels as well as existing ESAs but with fewer injections than currently available erythropoiesis-stimulating agents (ESAs). One of the pivotal studies from its phase III programme was just published in The Lancet.

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.

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 anaemia 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 haemoglobin level sufficient to avoid the need for RBC transfusion and not to exceed 12 g/dL

The use of Aranesp in paediatrics CRF patients as the initial treatment to correct anaemia has not been studied. In the maintenance phase Aranesp dosage should be adjusted to maintain the lowest haemoglobin level sufficient to avoid the need for RBC transfusion and not to exceed 12 g/dL. Doses must be individualized to ensure that haemoglobin 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 randomised non-inferiority trial (Maxima).