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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

WAYNE, N.J., Feb. 13, 2013 /PRNewswire/ -- Bayer HealthCare announced today that the New Drug Application (NDA) for its investigational oncology compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA). The application is currently under review for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

"We are pleased the FDA has granted priority review of the radium-223 new drug application for the treatment of patients with castration-resistant prostate cancer that has metastasized to the bones. Receiving this designation marks another positive milestone for radium-223 and underscores Bayer's ongoing commitment in oncology," stated Pamela A. Cyrus , MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months of the 60-day filing receipt of the NDA submission (eight months total), rather than the standard 12-month review cycle. 

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize radium-223 globally. Algeta will co-promote radium-223 with Bayer in the U.S.

About Radium Ra 223 Dichloride

Radium Ra 223 dichloride (radium-223), formerly referred to as radium-223 chloride, is an investigational alpha particle-emitting pharmaceutical in development for CRPC patients with bone metastases.

Radium-223 is an investigational agent and is not approved by the FDA, the Europe
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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