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EU approves Roche's Mircera for anaemia

Roche wins approval from the EU Commission for its renal disease-associated anaemia treatment, Mircera

Swiss-headquartered Roche has won approval from the EU Commission for its renal disease-associated anaemia treatment, Mircera (continuous erythropoietin receptor activator).

Mircera, which is an erythropoiesis stimulating agent, increases red blood cell counts in anaemia patients and reduces the need for continuing blood transfusions.

According to Roche, the EU approval is valid for 27 countries and will be launched first in the UK and Germany before later launches in other EU member states in 2007.

Roche had already included the EU approval into its share price after officials indicated the decision would be positive for the company. Roche shares were trading 0.4 per cent higher in a positive Swiss market at CHF 216.30 (USD 180) as a result.

Roche's old anaemia product, NeoRecormon, was its fifth best-selling drug with FY06 sales of CHF 2.2bn (USD 1.8bn). Roche executive Dan Kemmel added that the company expected Mircera to maintain NeoRecormonís market lead in mainstay non-US markets.

Mircera (US brand name Cera) was awarded approvable status by US regulators in May 2007, but still has not won approval. The US filing was based on the largest initial registration programme consisting of 10 global studies involving more than 2,700 patients. The phase III programme consisted of two correction and four maintenance studies exploring intravenous (IV) and subcutaneous (SC) Mircera at extended administration intervals for patients on dialysis and not on dialysis.

If approved, Cera will join a market controlled by US-based competitor Amgen, whose best-selling anaemia drugs are Epogen and Aranesp. Epogen, which is sold for dialysis use in the US, racked up sales of USD 2.5bn in FY06. Medicare, which pays for most dialysis treatments, spends more than USD 2bn a year on the drug.

Amgen and Roche are currently locked in a patent battle over anaemia drugs.

Kemmel added in a conference call that he expected US approval to follow a meeting of an FDA advisory panel on 11 September to review EPO drugs after studies showed an increased risk of death in cancer patients not on chemotherapy. Mircera is in mid-stage clinical trials for use in cancer.

30th July 2007

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