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OctreoPharm Sciences Gets FDA Orphan Drug Designation for Management of Neuroendocrine TumorsBERLIN --(Business Wire)-- OctreoPharm Sciences GmbH, based in Berlin (Germany), announced today that the radiopharmaceutical company has received U.S. FDA orphan drug designation for its new radiotracer OPS202, based on a next generation antagonistic somatostatin analog for the management of neuroendocrine tumors. The FDA orphan drug designation is designed to promote drugs that demonstrate value for relatively rare diseases that affect fewer than 200,000 people in the U.S. "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," said OctreoPharm`s Managng Director, Dr. Hakim Bouterfa. Other advantages of this designation are certain waived filing fees and additional tax credits. This designation comes after the orphan drug designation granted by the European Medicines Agency (EMA (News - Alert)) for OPS202. About OPS202 OPS202, which is currently in phase I/II clinical trials, is based on a new next generation antagonistic somatostatin analog with improved receptor binding to sst2. It has the potential to improve the imaging of NET (News - Alert) patients, eventually leading to a change in disease management of those patients. Due to the fact that the peptide can deliver up to 5 times more dose to the tumor, compared to the currently used second-generation agonists like DOTA-TATE, DOTA-TOC or DOTA-NOC (News - Alert), OctreoPharm Sciences is also developing the same peptide as an therapeutic drug (OPS201) following a Theranostic approach. About OctreoPharm Sciences GmbH OctreoPharm Sciences GmbH (founded 2009) is a privately held clinical stage biopharmaceutical company, focusing on the clinical development and commercialization of innovative radioactively labeled compounds for molecular imaging and for corresponding therapeutic applications in a new Theranostics approach. |
