US FDA fast-tracks Bayer and Algeta's prostate drug Alpharadin

Germany’s Bayer (BAY: DE) said this morning that its investigational compound Alpharadin (radium-223 chloride), licensed from Norwegian cancer drug developer Algeta ASA (OSE: ALGETA) in 2009 under an up to $800 million deal (The Pharma Letter September 3, 2009), has been granted fast track designation by the US Food and Drug Administration for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases.

Saying that this is an important milestone for Alpharadin, Kemal Malik, head of global development and member of the Bayer HealthCare executive committee, noted that "prostate cancer is a leading cause of death among men all over the world. There is a significant unmet need for patients suffering from the advanced stages of the disease, especially in patients whose cancer has spread to the bone."

Andrew Kay, Algeta’s president and chief executive, who has previously projected sales of $1.3 billion to $1.9 billion for the drug, 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,” adding that the companies now expect to file for Alpharadin’s US marketing approval in mid 2012, which is ahead of previous expectations.