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Xofigo® (radium Ra 223 Dichloride) Injection Recommended For Approval In The European Union

WHIPPANY, N.J., Sept. 20, 2013 /PRNewswire/ --  Bayer HealthCare announced today that the the European Committee for Medicinal Products for Human Use (CHMP) recommended Xofigo ® (radium Ra 223 dichloride) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. The decision of the European Commission on the approval is expected in the second half of 2013. Xofigo was approved by the U.S. Food and Drug Administration in May for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. 1

"We are encouraged by the positive CHMP opinion issued today, and look forward to potentially providing radium 223 to more patients upon approval of the European Commission," explained Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

About Xofigo ® (radium Ra 223 dichloride) Injection Xofigo is indicated in the United States for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 1

Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue. 1

In September 2009, Bayer signed an agreement with Algeta ASA ( Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. Algeta US, LLC is co-promoting Xofigo with Bayer in the US.

Important Safety Information for Xofigo ® (radium Ra 223 dichloride) InjectionXofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.

In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression –notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia– has been reported in patients treated with Xofigo.

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