FDA Grants Fast Track Designation to Bayer’s Investigational Compound Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone
WAYNE, N.J., Aug. 23, 2011 /PRNewswire/ — Bayer HealthCare Pharmaceuticals, Inc. today announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) 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.
“We are pleased that the FDA has granted Fast Track designation to radium-223 chloride,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “This is an important milestone in the overall development of this compound.”
Fast Track Designation in the United States
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. Fast Track addresses a broad range of serious diseases. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug 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 drug development and review process. The frequency of communication assures that 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 of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains 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.
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, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, 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.
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.