Oslo, Norway, 23 August 2011 - Algeta ASA (OSE: ALGETA) today announced that Alpharadin (radium-223 chloride) 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 bonemetastases
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 so that important new drugs are available earlier. 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.
Andrew Kay, Algeta's President and CEO, said: "The positive results at the pre-planned interim analysis of the pivotal phase III study, ALSYMPCA, (ALpharadin in SYMptomatic Prostate Cancer) was a great achievement for Algeta and for Bayer, reinforcing the common belief of Alpharadin's potential to become an important treatment for bone metastases initially with prostate cancer. We are pleased that Alpharadin now has been granted Fast Track designation by the FDA, as this represents an important step towards Alpharadin filing which we anticipate mid 2012 ahead of previous expectations."