Syncona says Blue Earth's Axumin gets EU approval

Heathcare investor Syncona said its portfolio company Blue Earth Diagnostics had received confirmation of approval of its Axumin prostate cancer diagnostic agent by the European Commission.

The approval means that Axumin can be sold in all European Union member states as well as Iceland, Liechtenstein and Norway. Axumin will initially be commercially available in Norway, with roll-out to additional countries planned in 2018.

Syncona holds a 90% interest in the share capital of Blue Earth Diagnostics.

Axumin is an injectable product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following initial therapy. PET imaging with Axumin may identify the location and extent of such recurrence, Syncona said in a statement.

Axumin was developed to enable visualisation of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope 18F for PET imaging.