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OctreoPharm Sciences gets orphan drug status for SOMscan for diagnosis of neuroendocrine tumours
Berlin, Germany | Thursday, October 13, 2011, 11:00 Hrs  [IST]

OctreoPharm Sciences GmbH, a Berlin based specialist for radiopharmaceuticals, announced 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-labelled radioactive contrast agent for positron emission tomography with the potential to detect neuroendocrine tumours currently in phase I. It binds to four out of five specific tumour receptor subtypes on the surface of neuroendocrine tumours. This may allow detection of neuroendocrine tumours which previously escaped discovery in imaging. The diagnosis of neuroendocrine tumours with SOMscan has the potential to be faster, more accurate, more reliable and more specific.

OctreoPharm Sciences GmbH is a privately held clinical development company focusing on radiopharmaceuticals for the diagnosis and therapeutic control of tumours.

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