Bayer Submits New Drug Application for Radium Ra 223 Dichloride for the
Treatment of Castration-Resistant Prostate Cancer (CRPC) with Bone Metastases
WAYNE, N.J., Dec. 14, 2012
WAYNE, N.J., Dec. 14, 2012 /PRNewswire/ --Bayer HealthCare today announced
that the company has submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) seeking approval for radium Ra 223 dichloride
(radium-223), an investigational compound for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone metastases.
"If approved, radium-223 has the potential to play a key role in the treatment
of men with CRPC that has metastasized to the bone," said Pamela A. Cyrus, MD,
Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "The development of a compound like radium-223 is an example
of Bayer's commitment to investing in approaches to treat hard-to-treat
Radium-223 was granted fast track designation by the FDA. The fast track
process is designed to facilitate the development and expedited review of
drugs to treat serious diseases and fill an unmet medical need. Fast track
designation must be requested by the drug company and can be initiated at any
time during the drug development process.
About the ALSYMPCA Trial
The submission was based on data from the ALSYMPCA (ALpharadin in SYMptomatic
Prostate CAncer) trial, a Phase III, randomized, double-blind,
placebo-controlled international study of radium-223 with BSC vs. placebo with
BSC in symptomatic CRPC patients with bone metastases. The trial enrolled 921
patients in more than 100 centers in 19 countries. The study treatment
consisted of up to six intravenous administrations of radium-223 or placebo
each separated by an interval of four weeks.
The primary endpoint of the study was overall survival. Secondary endpoints
included time to occurrence of skeletal-related events (SRE), time to total
alkaline phosphatase (ALP) and prostate-specific antigen (PSA) progression,
total ALP response and normalization, safety, and quality of life.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States
(other than skin cancer). ^ 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).
A majority of men with CRPC have radiological evidence of bone metastases.
Bone metastases secondary to prostate cancer typically target the lumbar
spine, vertebrae and pelvis. ^ In fact, bone metastases are the main cause
of morbidity and death in patients with CRPC.
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.
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 US.
Radium-223 is an investigational agent and is not approved by the FDA, the
European Medicines Agency (EMA), or other health authorities.
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
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.
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This news release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various
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whatsoever to update these forward-looking statements or to conform them to
future events or developments.
 American Cancer Society. Prostate Cancer: Detailed Guide. October 26,
2012. Available at:
Accessed May 17, 2012.
 National Cancer Institute, Surveillance Epidemiology and End Results
(SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008.
 Sartor, O. "Radiopharmaceutical and chemotherapy combinations in
metastatic castrate-resistant prostate cancer: a new beginning." JCO.
 Bone and Cancer Foundation. Questions & Answers about Prostate Cancer Bone
Metastases and Treatment-Related Osteoporosis. Available at:
May 17, 2012.
 Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding
prostate cancer metastatic to bone." Cancer & Metastasis
SOURCE Bayer HealthCare Pharmaceuticals Inc.
Contact: Rose Talarico, Bayer HealthCare Pharmaceuticals, +1-973-305-5302,
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