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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 European 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 and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer® and the Bayer Cross® are registered trademarks of Bayer. 

Intended for U.S. Media Only

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

(1) American Cancer Society. Prostate Cancer: Detailed Guide. October 26, 2012. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf. Accessed May 17, 2012.

(2) National Cancer Institute, Surveillance Epidemiology and End Results (SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008.

(3) Saad, MD, et. al. "Guidelines for the management of castration-resistant prostate cancer." Can Urol Assoc J 2010;4(6):380-4.

(4) Bone and Cancer Foundation. Questions & Answers about Prostate Cancer Bone Metastases and Treatment-Related Osteoporosis. Available at: http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf. Accessed May 17, 2012.

(5) Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding prostate cancer metastatic to bone." Cancer & Metastasis Reviews.1999;17:331-336.


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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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