Thursday, July 27, 2017
Blue Earth Diagnostics, a molecular imaging diagnostics company and M2i, a manufacturer of Positron Emission Tomography (PET) imaging agents, today announced that they have entered into an exclusive manufacturing and distribution agreement for the supply of Blue Earth Diagnostics’ PET imaging product Axumin™ (fluciclovine (18F)) in Ireland. M2i, through their Dublin PET manufacturing site, will bring Axumin to market in the Republic of Ireland and in Northern Ireland.
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*. Prostate cancer is the second most common cancer in Ireland for men, with around 3,200 new cases diagnosed each year1. While most primary prostate cancer 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 location of the recurrence cannot consistently be located 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. In June 2017, Blue Earth Diagnostics announced it had appointed AAA as a manufacturer and exclusive distributor for Axumin in France, Germany, Italy, Portugal and Spain.
Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “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 across Europe. This agreement is a key milestone in building our European manufacturing and distribution network for Axumin, and we look forward to working with the team at M2i.”
Ruairi O’Donnell, Managing Director of M2i said, “This is a very exciting development for the management of prostate cancer patients in Ireland and we look forward to growing the utilisation of PET in the Irish healthcare system.”
