Octreopharm Sciences Gets FDA Orphan Drug Designation For Management Of Neuroendocrine Tumors
BERLIN--(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 Managing 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) for OPS202.
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“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 Managing 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) for OPS202.
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