Novel neuroendocrine tumor scan gets European orphan drug designation

OctreoPharm Sciences based in Berlin announced Jan. 29 that OPS202, an imaging agent for the detection of gastro-entero-pancreatic neuroendocrine tumors, received orphan drug designation from the European Medicines Agency (EMA).

OPS202 is conjugated with the radionuclide gallium-68 (Ga-68) for diagnostic tests and is differentiated from other agonist agents in the Ga-68 family that includes Ga-68 DOTATATE, DOTATOC and DOTANOC. A new compound with yttrium-90 is currently in preclinical testing for therapeutic use.

“This designation is an important step in the development of a new and potentially heavily improved diagnostic and staging tool for a seriously debilitating and potentially lethal disease,” said OctreoPharm Sciences managing director Hakim Bouterfa, PhD.

OPS202 is member of a family of antagonistic peptides, unlike agonists DOTATOC, DOTATATE or DOTANOC that have been gaining attention in recent years. Antagonistic peptides such as OPS202 are not involved in G protein phosphorylation and independent of somatostatin receptor two activation states. This could mean that OPS202 can home in on a variety of surface receptors.

The EMA designation provides market exclusivity throughout Europe for 10 years once OPS202 is approved for clinical use and it also could lead to regulatory fee exemption during the drug development phase, which might bring the scan to market faster.