Jubilant Draximage Inc. and Evergreen Theragnostics, Inc announced a new agreement for Jubilant’s radiopharmacy business to prepare, sell, and distribute doses of OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection) to positron emission tomography (PET) customers across the US. OCTEVYTM is pending approval by the United States Food & Drug Administration (FDA), which is expected in 2H 2023.
| YARDLEY, Pa., and SPRINGFIELD, N.J., June 23, 2023 /PRNewswire/ -- Jubilant DraxImage Inc. (dba, Jubilant Radiopharma™), a Jubilant Pharma Company, through it’s Radiopharmacy business division which maintains the second largest nuclear medicine pharmacy network in the US, and Evergreen Theragnostics, Inc., a radiopharmaceutical company focused on improving the available options for cancer patients, announced a new agreement for Jubilant’s radiopharmacy business to prepare, sell, and distribute doses of OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection) to positron emission tomography (PET) customers across the US. OCTEVYTM is pending approval by the United States Food & Drug Administration (FDA), which is expected in 2H 2023.
OCTEVY™ is currently under evaluation by the FDA as a potential radioactive diagnostic agent indicated for use with PET for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. If approved, OCTEVY™ can provide a new imaging option for healthcare providers to aid in the management of NETs in their patients. Under the terms of the agreement, upon regulatory approval, Jubilant will reconstitute, radiolabel, and deliver OCTEVY™ doses ordered by hospitals and independent PET imaging centers in the United States. _________________________________________________ About Neuroendocrine Tumors Neuroendocrine tumors (NETs) are a diverse set of cancers that originate in neuroendocrine cells, which are cells that carry messages from the nervous system to the endocrine system. Because neuroendocrine cells are located in many organs, NETs are often heterogeneous in their symptoms and therefore difficult to diagnose. The incidence of NETs are low, but are increasing, likely in part due to increased diagnosis of the disease. Once a patient has been identified as having a NET, they will often undergo a PET scan to localize and state the cancer, which will help the care team identify the best course of treatment. About OCTEVY™ OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection), is currently under evaluation by FDA as a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. OCTEVY™ is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 DOTATOC injection with the eluate of Gallium from an on-site generator at the radiopharmacy. OCTEVY™ is not currently approved by the FDA and is not yet available for sale in the United States. About Jubilant Radiopharmacy Business Jubilant’s Radiopharmacy business is the second largest nuclear medicine pharmacy network in the United States, owns and operates 46 radiopharmacies across 21 states, offering an extensive portfolio of nuclear imaging products. Jubilant’s radiopharmacy business only supply FDA approved, high quality radiopharmaceuticals. We provide highly customized customer solutions and exceptional service to our customers and the patients they serve. For more information, please visit www.jdiri.com About Evergreen Theragnostics Evergreen Theragnostics, headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility, is focused on improving the available options for cancer patients using radiopharmaceuticals. Founded in 2019, the company is engaged in three core areas: CDMO, Products, and Drug Discovery. The CDMO business unit offers research and commercial scale, centralized production capacity for therapeutic and long-lived diagnostic products. The Products business unit develops and commercializes Evergreen-owned assets. Evergreen Discovery is focused on developing novel radiopharmaceuticals for cancer therapy, focusing on unprecedented and first-in-class radiopharmaceuticals. For more information, please visit www.evergreentgn.com. CONTACTS: Evergreen Theragnostics, Inc. Jubilant Radiopharma
SOURCE Evergreen Theragnostics, Inc. |
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