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Bayer to Present New Data Across Oncology Portfolio at ASCO 2013
Date:5/15/2013

tients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

For full prescribing information, including BOXED WARNING, visit www.stivarga-us.com.

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

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.

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.

Important Safety Information for Xofigo® (radium Ra 223 dichloride) Injection
Xofigo 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. Th
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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