Syncona Limited - Blue Earth Diagnostics achieves EMA approval on Axumin

Syncona

Blue Earth Diagnostics achieves EMA approval on Axumin

23 May 2017

Syncona Ltd (“Syncona”), a leading healthcare company focused on investing in and building global leaders in life science, is pleased to note that its portfolio company Blue Earth Diagnostics has received confirmation of approval of its product Axumin™ (fluciclovine (¹⁸F)) (“Axumin”) by the European Commission. This follows the announcement on 24 March 2017 that the Committee for Medicinal Products for Human Use had made a positive recommendation for Axumin to be granted marketing authorisation  

The approval means that Axumin is now authorised to 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 per cent interest in the share capital of Blue Earth Diagnostics.

[ENDS]

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Copies of this press release and other corporate information can be found on the company website at: www.synconaltd.com  

Forward-looking statements – this announcement contains certain forward-looking statements with respect to the portfolio of investments of Syncona Ltd. These statements and forecasts involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements and forecasts. Nothing in this announcement should be construed as a profit forecast. 

About Syncona:

Syncona is a leading FTSE250 healthcare company focussed on investing in and building global leaders in life science. Our vision is to deliver transformational treatments to patients in truly innovative areas of healthcare while generating superior returns for shareholders. Our current investment portfolio consists of seven high quality companies in life science and a leading range of fund investments. 

We seek to partner with the best, brightest and most ambitious minds in science to build globally competitive businesses. We are established leaders in gene therapy, cell therapy and advanced diagnostics, and focus on delivering dramatic efficacy for patients in areas of high unmet need.

Our market leading funds portfolio seeks to generate superior returns by investing in long only and alternative investment funds. This represents a productively deployed evergreen funding base which enables us to take a long term approach to investing in life sciences as we target the best new opportunities and support our existing portfolio companies to grow and succeed.

Syncona is aligned with two of the premium charitable funders in UK science, the Wellcome Trust, original founder of Syncona, and Cancer Research UK, both of which are significant shareholders in our business.  We make a donation of 0.3% of Net Asset Value to a range of charities each year.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a molecular imaging diagnostics company focused on the development and commercialisation of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognised experts in the clinical development and commercialisation of innovative nuclear medicine products.

Blue Earth Diagnostics’ first approved and commercially available product is Axumin™ (fluciclovine ¹⁸F), a novel molecular imaging agent approved in the United States for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. Blue Earth Diagnostics is funded by Syncona Limited, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdx.com.

About Axumin^TM (FLUCICLOVINE ¹⁸F)

Axumin (fluciclovine ¹⁸F) injection is a novel 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.

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.

Fluciclovine ¹⁸F was invented at Emory University in Atlanta, Ga. USA, with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

Axumin is the first product commercialised by Blue Earth Diagnostics. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

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