Development candidate SOMscan(R) against neuroendocrine tumors receives orphan drug status from the FDA

Press Release

Development candidate SOMscan^(R) against neuroendocrine tumors receives orphan drug status from the FDA

Berlin, October 16, 2014. OctreoPharm Sciences GmbH, in which Eckert & Ziegler Radiopharma GmbH holds an interest, has received the coveted and financially rewarding orphan drug status from the US Food and Drug Administration (FDA) for its new diagnostic agent SOMscan^(R). This status allows for a more cost effective approval procedure and provides the manufacturer with longer exclusivity. The European Medicines Agency EMA already awarded SOMscan^(R) orphan drug status at the beginning of 2014.

SOMscan^(R) is a gallium-68 labeled peptide for detecting neuroendocrine tumors using positron emission technology (PET). SOMscan^(R) is currently in clinical phase I/II and belongs to the class of somatostatin analogs with an antagonistic effect. The peptide can be used with the radioisotope for both the diagnosis and treatment of tumors. Based on the so-called theranostic approach, the same carrier molecule can be labeled first with gallium-68 and then yttrium-90.

The global market volume for the drug for the diagnosis and radiopharmaceutical treatment of neuroendocrine tumors is estimated at more than EUR 250 million p.a. Neuroendocrine tumors are generally malignant tumors of the gland cells in the lungs and the gastrointestinal tract that metastasize at an early stage.

About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700) is one of the world's largest providers of isotope technology for radiation therapy and nuclear medicine and has more than 700 employees worldwide.
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About Octreopharm Sciences
OctreoPharm Sciences GmbH is a nuclear medicine specialist focusing on the clinical development of radiopharmaceuticals for the diagnosis and therapeutic control of tumors. Octreopharm Sciences GmbH is held by Eckert & Ziegler AG, VC Funds Technology managed by IBB Berlin GmbH, KfW Mittelstandsbank, Eckert Life Science Accelerator GmbH, OctreoPharm GmbH and Chinese investor Shaanxi Xinyida Investment Co. Ltd.

About neuroendocrine tumors
Neuroendocrine tumors (NETs) represent a group of rare tumors. In Germany there are an estimated two to five cases per 100,000 people. NETs generally occur in the gastrointestinal tract and the pancreas. They are called neuroendocrine because their cells are similar to those of endocrine glands such as the pancreas. NETs grow slowly but spread very early. Most of the patients diagnosed already have metastases, usually of the liver, and can therefore often no longer be cured by surgery.

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Eckert & Ziegler AG
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