// Press release

DuChemBio Co., Ltd. & Life Molecular Imaging Announce Material Transfer And Clinical Supply Agreement for [18F]PI-2620 Tau PET Tracer

Investigational tau imaging agent [18F]PI-2620 added to the imaging biomarker platform for clinical studies in South Korea

SEOUL, South Korea, BERLIN, Germany, 17 August 2021 – DuChemBio Co., Ltd. and Life Molecular Imaging (LMI) announced today the signing of a Material Transfer & Clinical Supply Agreement for LMI’ next generation Tau PET Tracer PI–2620.

PI–2620 is an investigational Tau PET agent currently in late stage clinical development by LMI with excellent characteristics and diagnostic performance for the in–vivo assessment of Tau Pathology in Alzheimer’s Disease (AD) and other tauopathies by means of hybrid PET scanners.

Under the terms of the Agreement, DuChemBio, who operates the largest radiopharmacy network for a GMP–standard manufacturing of Nuclear Medicine probes for PET imaging in South Korea, has been granted a license to manufacture and supply PI–2620 clinical trial doses in South Korea.

The tracer shall be offered to support local clinical research (approved investigator initiated trials (IIT)) as well as clinical studies with disease modifying drugs (DMD) developed and sponsored by international Pharma companies. Supply of PI–2620 as a biomarker for local and DMD clinical trials research is expected to commence in the first half of 2022.

“Accurate diagnosis is a particular challenge in the complex spectrum of neurodegenerative disorders such as AD. The introduction of a Tau tracer to South Korea through the supply of PI–2620 for clinical investigations is very exciting. Tau PET is a promising imaging biomarker for the improved detection and characterization of neurodegenerative diseases, which also enables us to find and test more effective therapeutics for AD and other non–AD tauopathies. DuChemBio will continue to support the global clinical development of AD therapeutics” said DuChemBio’s CEO Jongwoo Kim.

“LMI continues to expand the availability of innovative molecular imaging agents for clinical investigations,” stated Ludger Dinkelborg, Ph.D., Managing Director at LMI. “We are truly proud and excited to move our PI–2620 Tau program forward with our Korean radiopharmacy partner DuChemBio. This is a major step forward as we continue to increase our global PI–2620 clinical supply network.”

“Tau deposits, in conjunction with beta–amyloid plaques, represent the critical pathologies in AD with Tau further playing an important role in other neurodegenerative diseases”, added Andrew Stephens, M.D., Ph.D., Chief Medical Officer at LMI. “Visualizing the Tau deposits and their spread in cognitively impaired subjects has the potential to provide a better understanding of the disease and to enable an earlier and more accurate diagnosis of AD and other neurodegenerative disorders. Tau and amyloid PET provides a powerful imaging biomarker platform for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases.”

About PI-2620 PI-2620
was discovered in a research collaboration with Life Molecular Imaging and AC Immune. Life Molecular Imaging has the exclusive world-wide license for research, development and commercialization of Tau-PET tracers generated within the discovery program. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain.

About Life Molecular Imaging LMI (formerly Piramal Imaging)
was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. LMI strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit https://life-mi.com.

About DuChemBio Co., Ltd.
Established in 2002, DuChemBio is the largest radiopharmaceutical firm and the undisputed leader in the field of oncology and neurology PET imaging tracers in South Korea. As a pioneer of a fully integrated nuclear diagnostics business model, DCB develops, manufactures, and commercializes radiopharmaceutical tracers for PET/CT and PET/MRI hybrid imaging. The company operates 7 radiopharmacy facilities across the country, is closely collaborating with leading hospitals and research centers in Seoul to develop and advance the field of nuclear medicine in South Korea. DCB has successfully launched novel proprietary radiopharmaceutical products both developed locally and licensed from international partners. DuChemBio has been advised by BGM Associates GmbH, a Berlin-based strategy and transactions advisory firm focused on healthcare and life science industries.

// Corporate Contact
Kini S. Kim
Director of Development and Planning Department

DuChemBio Co.
E-Mail: kini.kim@duchembio.com
Tel.: +82 2 332 4868

Teresia Möller
Director of Pharma Collaborations

Life Molecular Imaging
E-Mail: t.moller@life-mi.com
Tel.: +1 508 782 8087

Related Projects

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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