Ilumira authorization opens EU route for SHINE Lu-177

SHINE Technologies has received centralized European marketing authorization for Ilumira, its non-carrier-added lutetium-177 chloride radiopharmaceutical precursor. The authorization allows the company to sell Lu-177 into the European Union, according to SHINE.

EMA lists Ilumira as authorized for use in the European Union. The agency describes the product as a radioactive form of lutetium used to radiolabel other medicines and states that it is never given directly to a patient.

The product is used in a laboratory setting by specialists with experience in radiolabelling. EMA said the radiolabelled medicine is then administered according to that medicine’s own product instructions.

Ilumira carries lutetium-177 to the target site through the medicine it labels. EMA said Lu-177 emits beta-minus radiation for treatment and a small amount of gamma radiation that can be used for imaging.

The European approval covers a precursor, not a standalone patient-administered therapy. EMA said benefits and risks are assessed independently when Ilumira is added to a specific medicine.

Production takes place at SHINE’s Cassiopeia facility in Janesville, WI. The company described the site as one of North America’s largest non-carrier-added Lu-177 production facilities and said Ilumira is produced under cGMP and European Pharmacopeia standards.

Recent financing and infrastructure moves are part of the same nuclear medicine buildout. In February, SHINE said it raised $240M in equity funding led by NantWorks, with participation from Fidelity Management & Research Company, Sumitomo Corporation of Americas, Pelican Energy Partners, Deerfield Management, Oaktree Capital Management, and existing investors.

A DOE conditional loan commitment followed in April. The U.S. Department of Energy said it issued a conditional commitment for up to $263M to SHINE Chrysalis to support construction of the Chrysalis medical isotope production facility in Janesville.

SHINE also acquired Lantheus’ SPECT business in January. That acquisition included the North Billerica, MA, SPECT manufacturing facility and products including TechneLite, Cardiolite, NEUROLITE, and Xenon Xe-133 Gas.