Blue Earth Diagnostics announced today that GE Healthcare will manufacture its Axumin (fluciclovine (F-18)) PET imaging agent in the U.K.

After scoring CE mark in May, this agreement is the first step toward full commercial availability of Axumin in the region.

"Blue Earth Diagnostics chose GE Healthcare for its significant expertise in the production of radiopharmaceuticals, and for its considerable experience in manufacturing fluciclovine (18F) for Blue Earth Diagnostics' FALCON trial, the initial results of which were announced last week at ASTRO," Ted Broadbent, global brand director for Blue Earth Diagnostics, told HCB News.
Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe. In July, the company appointed M2i to manufacture and distribute Axumin in Ireland.

Manufacturing and distribution agreements have also recently been made in France, Germany, Italy, Portugal and Spain.

The European Commission approved Axumin for detecting prostate cancer recurrence in men with elevated prostate-specific antigen levels after primary curative treatment. Most primary prostate cancer can be effectively treated, but up to one-third of patients experience reoccurrence.

Prostate cancer is the second most common cancer in the U.K., according to Cancer Research UK. In 2014, there were 46,690 new cases of prostate cancer and 11,287 deaths as a result of the disease.

Disease reoccurrence can sometimes only be detected via elevated PSA levels, but conventional imaging is unable to consistently pinpoint the exact location of the reoccurrence. However, PET imaging with Axumin is capable of that because it targets the increase in amino acid transport.

Axumin received FDA approval in May 2016 after two studies confirmed its safety and efficacy.

The first study compared 105 Axium scans in men with suspected prostate cancer reoccurrence to histopathology obtained by prostate biopsy and biopsies of suspicious imaged lesions. Initially, radiologists onsite read the scans and then three independent radiologists read the same scans in a blinded study.

The second study assessed the agreement between 96 Axumin and C11 choline scans in patients with a 1.44 ng/mL median PSA value. Radiologists onsite read the scans and the same three radiologists from the first study read the Axumin scans in this second blinded study.

"Detection and localization of recurrent prostate cancer is a significant unmet medical need," said Broadbent. "As with any new molecular imaging technology for cancer, adoption is subject to appraisal and evaluation by the NHS and NICE, which is the next step toward full availability of Axumin in the U.K."

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