OctreoPharm Sciences GmbH, a Berlin-based specialist in nuclear medical pharmaceuticals (radiopharmaceuticals), announced that it has received the worldwide exclusive license for the development and commercialization of SOMscan, from Novartis Pharma AG.

The new Gallium-68-labelled radioactive contrast agent for positron emission tomography (PET) used by SOMscan has the potential to selectively detect and monitor neuroendocrine tumours. Following its potential registration, it could be, amongst other applications, used for this indication in conjunction with a new therapeutic drug.

SOMscan binds to four out of five specific receptor subtypes for the naturally-occurring hormone, somatostatin, on the cell surface of neuroendocrine tumours and uses high-resolution combined positron emission tomography and computed tomography (PET/CT) technique. This may allow detection of neuroendocrine tumours and metastases which previously escaped discovery in imaging diagnoses. The only agent registered to date for the diagnosis of these tumours binds to only one of these receptor subtypes and uses the less sensitive gamma camera technique.

By leveraging high-resolution PET/CT imaging technique, the diagnosis of neuroendocrine tumours with SOMscan has the potential to be faster, more accurate, more reliable and more specific – with a marked reduction of radiation exposure for the patient. The expectation is that tumours and metastases down to a size of approximately four millimeters can be detected in accurate anatomical correlation with SOMscan. Since both the SOMscan diagnostic and therapeutic agent bind to the same tumour receptors, this makes individual monitoring and management of the course of the disease possible – another step towards personalized medicine. Also, unlike conventional PET contrast agents, Gallium-68 can be delivered in small, metal containers, enabling diagnostics to be performed locally and eliminating the need for expensive and sophisticated radiochemical infrastructure.

“SOMscan is exactly the license candidate OctreoPharm Sciences has been looking for: a product with the capacity to help define future diagnostic standards and the potential to meet a clinical need for a large group of patients,” said Dr Hakim Bouterfa, managing director of OctreoPharm Sciences for the medical science sector. “Neuroendocrine tumours are difficult to diagnose, and we will make every effort to take SOMscan speedily through the clinical trials and make it available for patients. It is my belief that the active ingredient, pasireotide, in SOMscan is a highly promising product candidate with the potential to become the first officially registered Gallium-68-labeled diagnostic using positron emission tomography for patient selection, diagnosis and monitoring of neuroendocrine tumours.”

“We are experts in the development of radioactive pharmaceuticals with streamlined project management capabilities and great organization,” added Udo Blaseg, managing director of OctreoPharm Sciences for the commercial and technical sector. “We consider ourselves the ideal partner for the speedy, effective and successful implementation of such clinical development programs. We have the necessary medical, scientific, radiopharmaceutical and organizational competencies.”

Under the terms of the agreement, Novartis will receive an upfront payment and milestone payments upon regulatory approvals, as well as royalties. Novartis also has the right to re-acquire the rights to SOMscan on pre-agreed financial terms.

Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions or to treat various diseases, like cancer. The technique works by injecting into the patient’s body targeted radiopharmaceuticals that accumulate in the organs or lesions that reveal specific biochemical processes. Molecular Nuclear Diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET-CT (combined Positron Emission Tomography and Computertomography) is a highly sensitive imaging technology that enables physicians to diagnose different types of cancer and other diseases in their early stages.

OctreoPharm Sciences GmbH is a biopharmaceutical company in the field of radioactive labeled substances. The Berlin-based company is located on the campus of Berlin-Buch and focuses specifically on the development of radiopharmaceuticals to be used in nuclear medicine and oncology for diagnosis and therapeutic control of neuroendocrine tumours. Stockholders of OctreoPharm Sciences GmbH are Eckert Wagniskapital und Frühphasenfinanzierung GmbH (Berlin), VC Fonds Technologie managed by IBB Beteiligungsgesellschaft mbH (Berlin), KfW Bankengruppe (Bonn) and OctreoPharm GmbH (Waldburg/Baden-Württemberg).

The company intends to acquire licenses for other product candidates as well. OctreoPharm Sciences is on the lookout for collaboration with pharmaceutical companies which would benefit from their competences in the development of innovative radio pharmaceutical products for personalized medicine to be applied in the diagnosis and monitoring in combination with new therapeutic agents.