PharmaLogic 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
BOCA RATON, Fla. and SPRINGFIELD, N.J., June 13, 2023 /PRNewswire/ -- PharmaLogic Holdings Corp. and Evergreen Theragnostics, Inc., announced their agreement for PharmaLogic 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 their extensive network of 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) 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 excited about our partnership with PharmaLogic. Their network of radiopharmacies and focus on quality service to their customers will make OCTEVY™ available to more patients throughout the country and renders them an ideal commercialization and distribution partner."
Scott Holbrook, Chief Strategy Officer of PharmaLogic noted, "The addition of OCTEVY™ to PharmaLogic's portfolio of molecular imaging products enhances the capacity to serve our customers with the newest options for their patients. Through this partnership with Evergreen, PharmaLogic continues grow one of the largest theranostic portfolios globally for the benefit of patients with unmet clinical needs."
Under the terms of the agreement, upon regulatory approval, PharmaLogic 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.
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 PharmaLogic Holdings Corporation
PharmaLogic is a world-class contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to Take The Lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: www.radiopharmacy.com
About Evergreen Theragnostics
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.
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