OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a leading molecular imaging diagnostics company, and IASON Sp. z o.o., a leading supplier of radiopharmaceuticals, today announced that they have entered into exclusive manufacturing and distribution agreements for the supply of Blue Earth Diagnostics’ Positron Emission Tomography (PET) imaging product Axumin® (fluciclovine (18F)) in Poland. Under the terms of the agreements, IASON sp. z o.o., through their manufacturing site in Mszczonów, will bring Axumin to market in Poland. Axumin is indicated in Europe for use in PET imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Blue Earth Diagnostics now has six manufacturing and distribution agreements for Axumin in place covering seventeen European countries.
Prostate cancer is the second most common cancer in Poland for men. The incidence of malignant prostate cancer has increased rapidly over the past three decades; about 14 000 new cases are diagnosed each year1. While most primary prostate cancers can be successfully treated, the disease recurs in up to one-third of patients. In some patients, recurrent disease is detectable only by a rise in PSA levels, but often the anatomical location of the recurrence cannot consistently be identified by conventional imaging, limiting treatment guidance. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.
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. Following receipt of marketing authorization for Axumin from the European Commission on May 22, 2017, Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe.
Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “We’re delighted to announce these agreements, which mark another significant step towards our goal of making Axumin commercially available across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin for clinicians and their patients. The agreements with IASON Sp. z o.o. will enable us to serve imaging centres and hospitals across Poland, where prostate cancer is a major concern for men and their families. We look forward to working with the team at IASON Sp. z o.o..”
Przemysław Kozanecki, President of IASON Sp. z o.o. said, “We are excited that IASON Sp. z.o.o has become a partner in Blue Earth Diagnostics’ European network for the production and distribution of Axumin, which promises to help improve the care of prostate cancer patients in Poland. We look forward to bringing our expertise, capabilities and reliability to support the launch of this new PET imaging agent in Poland.”
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 experiencing suspected biochemical recurrence. 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.
About IASON Sp. z o.o.
IASON Sp. z o.o. is the first commercial manufacturer and distributor of radiopharmaceuticals for Positron Emission Tomography (PET) in Poland, used in oncological, cardiological and neurological diagnostics. IASON manufactures and delivers to PET sites on a routine basis 18F- based radio-pharmaceuticals under EU permits both in Poland and abroad. Manufacturing facilities are located in Warsaw, Kielce and Mszczonów and fully meet GMP and national standards. IASON’s employees are one of the most experienced in the sector. IASON is a member of the Synektik Capital Group, listed on the Warsaw Stock Exchange. For more information please go to: www.synektik.com.pl
1. Data from: http://onkologia.org.pl/raporty downloaded 4 June 2018
This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.