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Roche files CERA for renal anaemia in U.S.

Thu Apr 20, 2006 2:07 AM ET

ZURICH, April 20 (Reuters) - Swiss drugmaker Roche Holding AG has filed its CERA drug to the U.S. Food and Drug Administration for marketing approval in the United States as a treatment for renal anaemia, the firm said on Thursday. Roche said it had requested approval for the drug to treat anaemia associated with chronic kidney disease in patients who are on dialysis as well as those who were not.

Roche faces a lawsuit over the drug from Amgen < AMGN >, which claims that CERA infringes on patents it holds for its own anaemia treatment, Epogen.

Amgen, a California-based biotech firm, said earlier this month it was asking the U.S. government to ban imports of CERA, a version of the protein EPO or erythropoietin which increases the production of red-blood cells.

Analysts have said that, while Roche is running a risk by ploughing on with a filing at a time when legal action is ongoing, the move is understandable since CERA could garner up to $2 billion a year in additional revenues.

In addition to renal anaemia, Roche plans to file the drug for anaemia caused by kidney cancer.

CERA is being developed as a follow-up product to its NeoRecormon, Roche's second-best selling drug in 2005 with sales of 2.3 billion Swiss francs ($1.81 billion).

Last November, Amgen filed a patent infringement lawsuit against Roche seeking an injunction preventing the manufacture or sale of recombinant human erythropoietin, including pegylated versions.

Amgen also sells Aranesp, a longer-lasting version of Epogen, which is marketed in the United States as a treatment for kidney dialysis patients as well as for anaemia in cancer patients undergoing chemotherapy.

Amgen's combined sales of Epogen and Aranesp totalled nearly $6 billion last year
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