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Blue Earth Diagnostics Celebrates Five Year Anniversary

OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a leading molecular imaging diagnostics company, recently celebrated the company’s five year anniversary. During this time, Blue Earth Diagnostics has delivered five years of innovation and continued growth with a proven track record and depth of expertise in the rapid development and global commercialization of radiopharmaceuticals for cancer management. Blue Earth Diagnostics employs over 100 people in Europe and in the USA.

“We’re excited to celebrate our five year anniversary. When we set out in 2014, the goal was to develop and commercialize positron emission tomography (“PET”

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Blue Earth Diagnostics was formed in March 2014, to develop and commercialize molecular imaging agents addressing areas of high unmet medical need. The company’s first commercially available product, Axumin® (fluciclovine F 18), received U.S. Food and Drug Administration (FDA) approval in May 2016 and European Medicines Agency (EMA) marketing authorization in May 2017. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon. Since commercial launch in late 2016 in the USA, Blue Earth Diagnostics has delivered a strong performance of Axumin, with over 28,000 patients dosed. The company has also seen robust organic growth and reordering rates, has reached profitability and reports revenues of £35M for the period April to September 2018.

In April 2018, Blue Earth Diagnostics opened its new expanded global headquarters at The Oxford Science Park, Oxford, UK. The offices were officially opened by Baroness Manningham-Buller, Chair of the Wellcome Trust, in the presence of Professor Sir John Bell, Regius Professor of Medicine at the University of Oxford and Sir William Castell, former chairman of the Wellcome Trust, with guests from the UK’s life science and medical imaging community joining the occasion in celebrating the company’s continued growth and commitment to innovation in molecular imaging.

May 2018 saw Blue Earth Diagnostics expand its Oncology Portfolio with exclusive, worldwide licensing of Investigational Radiohybrid PSMA-targeted Agents for Prostate Cancer from Scintomics GmbH, Germany, a specialist in radiopharmaceuticals and radiopharmaceutical technologies. The agreement supports the company’s strategic focus and advancement in its mission to develop and deliver products that address unmet medical needs in prostate cancer.

In December 2018, Blue Earth Diagnostics announced that the FDA had accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin® (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.

Dr. Jonathan Allis, founding Chief Executive Officer of Blue Earth Diagnostics said, “We’re excited to celebrate our five year anniversary. When we set out in 2014, the goal was to develop and commercialize positron emission tomography (“PET”) agents. With the expertise of our team in the areas of clinical development and commercialization of innovative nuclear medicine products, Blue Earth Diagnostics was able to launch Axumin, our first approved and commercially available product in the United States and European Union. As a result, we have experienced dynamic growth throughout the entire company, particularly in the USA, a testimony to the passion and dedication of our employees in delivering upon our corporate mission. Our investment in new compounds and new indications demonstrates our passion and belief in the power of radiopharmaceuticals. We are committed to continuing research in new technologies for the development of innovative products to guide clinicians and provide better outcomes for patients, and our work so far positions us well for the future. I’m extremely proud of this organization, of the talent and collective expertise. Thank you to all of our supporters and our employees worldwide.”

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization 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 recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially available product is Axumin® (fluciclovine F 18), a novel molecular imaging agent approved in the United States and European Union for use in PET imaging to detect and localize prostate cancer in men with a diagnosis of biochemical recurrence. The company’s pipeline includes Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid (“rh”) agents. rhPSMA is a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer. Blue Earth Diagnostics is backed by Syncona, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdiagnostics.com.

This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe. The approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label at www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004197/human_med_002100.jsp&mid=WC0b01ac058001d124 for complete information or contact Blue Earth Diagnostics.



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