WAYNE, N.J., Feb. 2, 2012 /PRNewswire/ -- Bayer HealthCare, LLC today announced that the U.S. Food and Drug Administration agreed that Bayer can proceed with its expanded access program to provide the investigational drug radium-223 chloride to patients diagnosed with castration-resistant prostate cancer (CRPC)/hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases. Radium-223 chloride will be made available to patients through qualified clinical sites participating in this program.
Expanded access refers to the use of an investigational drug, under certain circumstances, to treat patients with a serious disease or condition who cannot participate in a controlled clinical trial.[1]
For more information on this program, visit www.clinicaltrials.gov [NCT01516762].
About Radium-223 Chloride
In September 2009, Bayer signed an agreement with Algeta for the development and commercialization of radium-223 chloride. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for co-promotion and profit-sharing in the United States.
Radium-223 chloride is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA), or other health authorities.
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 (reg’d) and the Bayer Cross (reg’d) are trademarks of Bayer.
Forward-Looking Statements
This 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 conformthem to future events or developments.
[1] ClinicalTrials.gov. Understanding Clinical Trials. Available at: http://clinicaltrials.gov/ct2/info/understand#Q20. Accessed on January 30, 2012.
SOURCE Bayer HealthCare, LLC
