If approved, analysts predict that the drug could achieve sales of up to $2 billion per year.
However, Cera is currently the subject of a lawsuit being brought by the US biotech giant Amgen which alleges that the drug infringes patents covering erythropoietin which forms the basis of its own anti-anemia drug, Epogen.
Roche, however, insists that Cera does not infringe the Amgen patents. “The activity of Cera at the receptor sites involved in stimulating red blood cell production is different from what has been observed for erythropoietin, and this distinct molecular interaction is believed to have a role in providing targeted, stable and sustained control of anemia,” said the company in a statement.
The biological license application (BLA) submission is based on the largest clinical program ever undertaken for a drug treating renal anemia, with 10 clinical trials involving more than 2,700 patients from 29 countries. It included results from six phase III trials of both intravenous and subcutaneous Cera administered up to once every four weeks.
Roche recently successfully completed the last two pivotal phase III clinical trials for Cera that examined correction of anemia in untreated patients on dialysis and not on dialysis.
“The BLA filing for Cera brings us another step closer to making this important therapy available to the millions of CKD (chronic kidney disease) patients in the US who are at risk for the devastating effects of anemia,” said George Abercrombie, president and CEO, Hoffmann-La Roche. “We believe Cera will provide these CKD patients with sustained control of anemia and convenient extended dosing intervals.”