Algeta ASA has announced that Xofigo® (radium Ra 223 dichloride) injection, recently approved by the US Food and Drug Administration (FDA) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease, has been launched in the United States and the first sale has been made.
The first commercial sale of Xofigo triggers a EUR 50 million milestone payment to Algeta from Bayer under the terms of the 2009 development and licensing agreement.
Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare are co-promoting the product in the US.
Algeta’s President & CEO, Andrew Kay, commented: “We are delighted to announce the first sale of Xofigo, following its approval by the FDA. The development of bone metastases is a frequent consequence in men with castration-resistant prostate cancer, and is a major cause of disability and death in this disease. These patients have limited therapeutic options and we anticipate that Xofigo will be an important and welcome new addition to the treatment paradigm.”