UPPI and Evergreen Theragnostics Announce Partnership for Sales and Distribution of Octevy™ (Kit for Preparation of Ga 68 DOTATOC Injection), pending FDA approval in 2H 2023

25 Sep 2023
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SUWANEE, Ga. and SPRINGFIELD, N.J., Sept. 25, 2023 /PRNewswire/ --
Evergreen Theragnostics, Inc., announced their agreement allowing UPPI participating pharmacies to prepare, sell, and distribute Octevy™ (Kit for Preparation of Ga 68 DOTATOC Injection), if approved by the United States Food & Drug Administration (FDA), to PET customers across the country.
Octevy™ is currently under evaluation by the FDA as a potential radioactive diagnostic agent indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs)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.
Eric Luthi, Chief Commercial Officer of Evergreen Theragnostics commented, "we are thrilled to add UPPI participating pharmacies to our network of distribution partners. The independent radiopharmacies that belong to the UPPI network are vital partners to help make Octevy™ available to more patients throughout the country."
John Witkowski, President of UPPI said, "The addition of Octevy™ to the UPPI molecular imaging product offerings expands our ability to serve our PET customers and through them, patients with neuroendocrine tumors."
Under the terms of the agreement, upon regulatory approval, UPPI will reconstitute, radiolabel, and deliver Octevy™ doses ordered by hospitals and independent PET imaging centers in the United States.
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)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 UPPI
Established in 1998, UPPI has become a leader in traditional nuclear medicine and in the rapidly growing nuclear and PET pharmacy industries. Representing more than 60 independent and institutional operating sites across the country, UPPI provides its members national strength in buying relationships as well as access to customizable local programs that advance the professionalism of the industry. For more information, visit: www.uppi.org
Evergreen Theragnostics, founded in 2019, is a US-based radiopharmaceutical company consisting of three business units: CDMO, Products, and Discovery. Our CDMO business unit is dedicated to high quality & high reliability manufacturing of radiopharmaceuticals using a variety of isotopes, from early development through commercialization. We offer research and commercial scale, centralized production capacity for therapeutic and long-lived diagnostic products built into our brand-new state of the art manufacturing facility. Our combination of top industry talent, compliance with global cGMP standards, and strategic facility location uniquely position Evergreen as a premier radiopharmaceutical development, manufacturing, and distribution organization in North America. The Products business unit will commercialize Evergreen-owned assets. An NDA for the first product, Ga 68 DOTATOC, has been submitted to the FDA and will launch in late 2023, if approved. Evergreen Discovery, formed earlier this year, is focused on developing novel radiopharmaceuticals for cancer therapy, focusing on unprecedented and first-in-class radiopharmaceuticals.
CONTACTS:
James Cook
Chief Executive Officer
[email protected]
John Witkowski
President
[email protected]
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