ITC ENDS PROBE OF ROCHE'S IMPORTATION OF C.E.R.A.

The International Trade Commission (ITC) decided not to review its administrative law judge's decision to terminate the investigation of the importation of C.E.R.A. (Continuous Erythropoietin Receptor Activator) into the United States, Roche announced. Therefore, the investigation is ended.

Roche maintains its position that its investigational anti-anemia drug does not infringe on any of Amgen's U.S. patents for epoetin. The Swiss company will continue to focus its efforts on obtaining regulatory approval from the FDA for C.E.R.A., which is being developed for the treatment of renal anemia in chronic kidney disease patients. The U.S. has approximately 20 million patients suffering from chronic kidney disease, the ITC ENDS PROBE OF ROCHE'S IMPORTATION OF C.E.R.A. The International Trade Commission (ITC) decided not to review its administrative law judge's decision to terminate the investigation of the importation of C.E.R.A. (Continuous Erythropoietin Receptor Activator) into the United States, Roche announced. Therefore, the investigation is ended.

Roche maintains its position that its investigational anti-anemia drug does not infringe on any of Amgen's U.S. patents for epoetin. The Swiss company will continue to focus its efforts on obtaining regulatory approval from the FDA for C.E.R.A., which is being developed for the treatment of renal anemia in chronic kidney disease patients. The U.S. has approximately 20 million patients suffering from chronic kidney disease, the largest such population in the world.

"The ITC's decision supports our long-term efforts to develop C.E.R.A. We want to offer doctors and patients in the United States the choice of a novel medicine that has been created to allow longer dosing intervals of up to every four weeks -- something that currently does not exist in the United States," William Burns, CEO of Roche Pharma Division, said.

C.E.R.A. is the first continuous erythropoietin receptor activator. Its activity at receptor sites that stimulates red blood cell production is different from that of traditional epoetin drugs. largest such population in the world.

"The ITC's decision supports our long-term efforts to develop C.E.R.A. We want to offer doctors and patients in the United States the choice of a novel medicine that has been created to allow longer dosing intervals of up to every four weeks -- something that currently does not exist in the United States," William Burns, CEO of Roche Pharma Division, said.

C.E.R.A. is the first continuous erythropoietin receptor activator. Its activity at receptor sites that stimulates red blood cell production is different from that of traditional epoetin drugs.