BERLIN, October 12, 2011 /PRNewswire/ --
OctreoPharm Sciences GmbH, a Berlin based specialist for radiopharmaceuticals, announced today that the European Medicines Agency has granted Orphan Drug status to OctreoPharm Sciences product SOMscan® for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours.
The Orphan Drug status entitles OctreoPharm Sciences to ten year market exclusivity in Europe following marketing approval for SOMscan®. The designation also provides for special benefits, including possible exemptions in certain regulatory fees during development.
"We are proud to have received this Orphan Drug Designation for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours" said Dr. Hakim Bouterfa, Managing Director and Head of R&D. Udo Blaseg, Managing Director and Head of Operations added: "This designation is an important step for a new and heavily improved diagnostic and staging tool for a seriously debilitating and potentially lethal disease."
SOMscan is a new Gallium-68-labeled radioactive contrast agent for positron emission tomography with the potential to detect neuroendocrine tumors currently in Phase I. It binds to four out of five specific tumor receptor subtypes on the surface of neuroendocrine tumors. This may allow detection of neuroendocrine tumors which previously escaped discovery in imaging. The diagnosis of neuroendocrine tumors with SOMscan has the potential to be faster, more accurate, more reliable and more specific.
About OctreoPharm Sciences GmbH
OctreoPharm Sciences GmbH is a privately held clinical development company focusing on radiopharmaceuticals for the diagnosis and therapeutic control of tumors. The company intends to acquire licenses for other product candidates as well. OctreoPharm Sciences is in particular on the lookout for collaborations with pharmaceutical companies which focus on products for personalized medicine and new therapeutic agents.
OctreoPharm Sciences GmbH