News | August 27, 2011

FDA Grants Fast Track Designation to Bayer Compound

August 25, 2011 — Bayer HealthCare Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational compound, radium-223 chloride, exclusively licensed from Algeta ASA. The compound is for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases.

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

Fast Track Designation in the United States

Fast Track is a process designed to facilitate development and expedite review of drugs to treat a broad range of serious diseases and fill an unmet medical need. The designation must be requested by the drug company and can be initiated at any time during the development process. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire development and review process. The frequency of communication assures questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases. In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223 chloride. Under the terms, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally. Algeta will retain an option for up to 50/50 co-promotion and profit-sharing in the United States.

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in northern European countries and the United States. In 2008, an estimated 903,000 men had prostate cancer and 250,000 died from the disease worldwide.

Castration-resistant prostate cancer (CRPC) was formerly known as hormone-refractory prostate cancer (HRPC). The majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that can significantly impair a man's health. In fact, bone metastases are the main cause of disability and death in patients with CRPC.

For more information: www.pharma.bayer.com

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