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U.S. FDA Grants Priority Review to Bayer's Radium Ra 223 Dichloride NDA for Castration-Resistant Prostate Cancer with Bone Metastases
Date:2/12/2013

an Medicines Agency (EMA), or other health authorities. Bayer has submitted a Marketing Authorization Application to the EMA for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.

In January 2013, the U.S. Nuclear Regulatory Commission (NRC) issued a licensing decision on the medical use of radium-223. The decision states that U.S. medical sites will be able to procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR section 35.300.

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in the United States (other than skin cancer).(1) Approximately 16% of prostate cancer cases are considered regional or distant, which means that the cancer has spread beyond the prostate to nearby or distant areas of the body (metastasis).(2)

A majority of men with CRPC have radiological evidence of bone metastases.(3)  Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis.(4)  In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.(5)

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer's oncology franchise now includes two oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes novel targets and pathways with the potential to transform the way that cancer is treated across tumor types and stages of disease.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare a
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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