GE Healthcare has signed up to produce Blue Earth Diagnostics’ positron-emission tomography (PET) imaging product in the United Kingdom. The deal moves Blue Earth a step closer to making its recently approved prostate cancer agent available in its home country.
Oxford, U.K.-based Blue Earth won a European marketing authorization for its synthetic L-leucine analogue radiolabeled with fluorine 18 agent earlier this year. That regulatory nod recognized the scope for the imaging agent, branded Axumin, to make it easier for doctors to differentiate tumors from healthy tissues. This differentiation is particularly important when biomarker changes suggest the cancer has recurred but the tumor is invisible to older imaging techniques.
Blue Earth responded to the receipt of a European regulatory recommendation for Axumin in March by stepping up discussions with manufacturers and distributors. That led to an agreement with Axumin covering France, Germany, Ireland, Italy, Portugal and Spain. And now to the U.K. pact with GE, the company Blue Earth spun out of 2014.
“This agreement with GE Healthcare marks the first step towards full commercial availability of Axumin in the U.K.,” Blue Earth CEO Jonathan Allis said in a statement.
The U.K. is potentially a significant market for Blue Earth. Close to 50,000 cases of the disease are diagnosed in the country each year. The cancer will recur in about two-thirds of these people after successful initial treatment. In a subset of these recurring patients, a change in prostate specific antigen (PSA) levels will be the only evidence that the cancer is back. This is the population Blue Earth is targeting.
Blue Earth has set itself up to improve the treatment of these patients with the support of Syncona Partners, which owned 90% of the diagnostics startup as of the end of August. Syncona valued its 90% stake at about $153 million, suggesting Blue Earth is worth in the region of $170 million.
With the clearance of regulatory and commercial barriers to adoption of Axumin in Europe coming the year after the FDA approved the agent, Blue Earth is now positioned to generate sales to justify that valuation.