January 10, 2013 — Bayer HealthCare 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, M.D., 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 cancers."

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.

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).[1] Approximately 16 percent 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 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 United States.

Radium-223 is an investigational agent and not approved by the FDA, the European Medicines Agency (EMA) or other health authorities.

For more information: www.bayer.com

References:
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. Sartor, O. "Radiopharmaceutical and chemotherapy combinations in metastatic castrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-2418.

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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