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Lauren Dubinsky, Senior Reporter | October 12, 2017
For certain European countries
Blue Earth Diagnostics announced on Tuesday a manufacturing and distributing agreement with Seibersdorf Laboratories for the supply of its Axumin PET imaging agent in certain European countries.
"Seibersdorf Laboratories has decades of experience in the production of radiopharmaceuticals and are well located for distribution onward into central Europe, potentially expanding the footprint for Axumin to add seven additional countries in Europe," Jonathan Allis, CEO of Blue Earth Diagnostics, told HCB News.
The radiopharmaceutical company will be the exclusive distributor of Axumin in Austria. It will also manufacture the supply of the imaging agent in Austria, Czech Republic, Croatia, Germany, Hungary, Slovakia and Slovenia.
This is the second agreement reached by Blue Earth Diagnostics for Axumin this month, and the third in the past few months. Earlier this month the company announced that
GE Healthcare will manufacture Axumin in the U.K. and in July,
M2i was selected to manufacture and distribute it in Ireland.
These deals are getting Blue Earth Diagnostics closer to meeting its goal of making Axumin commercially available across Europe for the detection and localization of recurrent prostate cancer, according to Allis.
The company
scored European approval to market Axumin for that indication in May. It's the company's first approved product in the continent.
Axumin was also
approved for use in the U.S. in May 2016 after two studies demonstrated its safety and efficacy.
When asked why Blue Earth Diagnostics is partnering with companies instead of manufacturing and distributing Axumin itself, Allis said that there is a well-established network of manufacturers and distributors for F-18 labelled PET products in Europe.
"Working with established manufacturing companies enables Blue Earth to rapidly expand the availability of Axumin across Europe and benefit from local expertise and relationships," he added.