R-PHARM US announces the acquisition of IXEMPRA (ixabepilone) from Bristol-Myers Squibb (BMY). IXEMPRA received marketing approval from the U.S. Food and Drug Administration in 2007 and in 18 other markets globally. IXEMPRA is indicated as monotherapy or in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. With the acquisition, R-PHARM US has launched its U.S. commercial operations, and it is now responsible for all activities surrounding IXEMPRA’s manufacture, distribution, sales, and reimbursement.
On October 16, 2007, the U.S. Food and Drug Administration approved ixabepilone for the treatment of aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies. In November 2008, the EMEA has refused a marketing authorisation for Ixabepilone.