Roche's long-acting anemia agent CERA has a distinct molecular interaction from that of other erythropoietin agents, the firm said April 20.

Roche announced that it has submitted a BLA for the continuous erythropoietin receptor activator to treat anemia associated with chronic kidney disease, including patients on dialysis. A standard 10-month review would give CERA an estimated user fee date in mid February.

If approved, CERA would be the only continuous EPO product in the U.S., the firm said.

"The activity of CERA at the receptor sites involved in stimulating red blood cell production is different from what has been observed" for erythropoietin, Roche said. "This distinct molecular interaction is believed to have a role in providing targeted, stable and sustained control of anemia."

Roche's position could be used by the Swiss drug maker to defend a lawsuit filed against the company in November by Aranesp (darbepoetin alfa) manufacturer Amgen. The suit claims that CERA infringes six Amgen patents regarding "pioneering inventions" related to erythropoietin (¹ Also see "Roche Delays CERA Oncology Filing Until 2009" - Pink Sheet, 1 February, 2006.).

Roche previously said it is confident in its intellectual property profile for CERA, claiming that the product's longer half-life allows less-frequent dosing (² Also see "Roche Has “Reasonable” Chance Of Launching Its Long-Acting EPO In U.S." - Pink Sheet, 16 September, 2004.).

According to Roche, the BLA for CERA is supported by six Phase III trials of patients treated every four weeks. The trials met their primary endpoints of hemoglobin level maintenance.

Aranesp is approved for both weekly dosing and administration every three weeks, while Johnson & Johnson's Procrit (epoetin) is administered once a week.

In addition to the ongoing suit, Amgen recently moved to prevent CERA's arrival on the market by filing a complaint against Roche with the U.S. International Trade Commission (³ Also see "Amgen Seeks Order Against Roche Peg-EPO Importation" - Pink Sheet, 12 April, 2006.).

Roche is also planning to submit a chemotherapy-related anemia indication for CERA in 2009.

-Kathleen Michael

Roche Continuous Epoetin CERA BLA Submitted For Dosing Every Four Weeks

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