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www.fdanews.com/articles/90910-roche-s-once-weekly-neorecormon-approved-in-europe

ROCHE'S ONCE-WEEKLY NEORECORMON APPROVED IN EUROPE

January 10, 2007

Roche announced it has received European marketing approval for a once-weekly dosage of NeoRecormon (epoetin beta) for subcutaneous injection for the treatment of anemia in patients with solid cancers receiving chemotherapy. NeoRecormon was previously approved for administering three times per week.

Once-weekly NeoRecormon is proven to effectively and rapidly correct anemia regardless of the type of chemotherapy patients receive, according to Roche. It also reduces the need for blood transfusions by at least 50 percent compared with standard care and has been shown to significantly increase the time until patients need a first transfusion.

Key supportive data for the new indication came from the BRAVE study, which was conducted in women with metastatic breast cancer receiving chemotherapy, and the NAUTICA study, which was conducted in patients with a wide range of cancer types also receiving chemotherapy.