Currently, OPS202 is evaluated in Phase I/II clinical trials and is based on a new next generation antagonistic somatostatin analog with improved receptor binding to sst2.
The company said that OPS202 has the potential to improve the imaging of NET patients, eventually leading to a change in disease management of those patients.
Compared to the currently used second-generation agonists like DOTA-TATE, DOTA-TOC or DOTA-NOC, peptide can deliver up to five times more dose to the tumor and so the company is also developing the same peptide as an therapeutic drug (OPS201) after a Theranostic approach.
OctreoPharm managing director Hakim Bouterfa said: "This Orphan Drug designation provides further validation of OPS202, underscores the need for innovations in Nuclear Medicine, Radiopharmacy as well as the management of patients with neuroendocrine tumors, and, importantly strengthens OctreoPharm`s competitive position by providing seven years of market exclusivity in this indication."
The FDA orphan drug status is designed to promote drugs that show value for relatively rare diseases that affect fewer than 200,000 people in the US.
Other advantages of the orphan drug designation are certain waived filing fees and additional tax credits.