Algeta announces that Xofigo® (radium-223 dichloride) has been approved by the US FDA - Seite 3

The ALSYMPCA trial was a phase III, randomized, double-blind, placebo-controlled international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC patients with bone metastases treated with best standard of care compared with placebo plus best standard of care. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of radium-223 or placebo each separated by an interval of four weeks.

The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases

Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

A 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 pain, fracture and other complications that can significantly impair a man's health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

About the Patient Assistance Program

Bayer and Algeta offer patient assistance through Xofigo Access Services^SM which will assist with obtaining coverage and patient support of Xofigo. Patients and providers may contact the program at 1-855-6XOFIGO (1-855-696-3446) for additional information.

Details of international conference call

A conference call for investors, analysts and the press, and hosted by Algeta's senior management team, will take place tomorrow at 08:00 CET. To participate in the conference call, please dial the appropriate number below five minutes prior to the call:

US: [phone]
UK: [phone] (toll free 0808 109 0700)
Norway: [phone] (toll free 800 19 457)

Password: Algeta

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To access the replay (available for seven days), please dial:

US: [phone]
UK: [phone]
Norway: toll free 800 19 101

Participant pin code: 9227182

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For further information, please contact: