PRESS RELEASE

Life Molecular Imaging Announces New Data on Amyloid PET Quantification

Results published in European Journal of Nuclear Medicine and Molecular Imaging demonstrate the adjunct value of quantification for florbetaben

BERLIN, Germany, June 14, 2023 – Life Molecular Imaging (LMI) is pleased to announce the publication of a significant retrospective analysis utilizing the amyloid positron emission tomography (PET) tracer, NeuraCeq® (florbetaben18F). The study’s findings demonstrate the robust and homogeneous performance of quantitative methods, employing both CE marked software and other widely available processing tools. These quantitative methods provide comparable results to visual assessments of NeuraCeq® (florbetaben18F) PET scans. Importantly, excellent diagnostic efficacy was demonstrated when compared to histopathology assessment, with a mean sensitivity of 96.1% and specificity of 96.9% across all software packages.

As a result of these compelling findings, an updated label for NeuraCeq® was approved for use of PET scan quantification as an adjunct to visual assessment in the European Union (EU) and the United Kingdom (UK). The Committee for Medicinal Products for Human Use (CHMP) considered the use of approved CE marked software for quantitation appropriate to provide supplemental information when the reading physician requires further assistance in guiding the image assessment. In response to this update, LMI has provided amended educational materials in major EU markets, which include an additional module on the use of NeuraCeq® PET quantification as an adjunct to visual assessment.

Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging, expressed the significance of these findings by stating, “Anti-amyloid therapies are on the horizon and highlight the importance of an early and accurate diagnosis in Alzheimer’s disease (AD). Amyloid PET has played a pivotal role in the recent positive study outcomes for new AD drugs such as lecanemab and donanemab, by selectively including patients with confirmed amyloid pathology in the brain. The ability to quantify the amyloid burden opens up exciting avenues for the future. We are excited to have the adjunct use of quantification now included in our EU and UK labels.”

Dr. Andrew Stephens, M.D., Ph.D., Chief Medical Officer at Life Molecular Imaging, also shared his enthusiasm, stating, “We are highly encouraged by the very homogeneous and robust data provided by all 15 quantification methods in this study. We are excited to offer updated educational materials in EU markets as part of our dedicated NeuraCeq® reader training program.”

For further details regarding the published work, please visit https://link.springer.com/article/10.1007/s00259-023-06279-0 

About Neuraceq (florbetaben 18F)

Indication

Neuraceq® is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation.

A negative Neuraceq® scan indicates sparse to no plaques, which is not consistent with a diagnosis of AD. Neuraceq is for diagnostic use only.

Limitations of Use

  • A positive Neuraceq® scan does not independently establish a diagnosis of AD or other cognitive disorder, since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia).
  • The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established.
  • Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blurs, which could lead to interpretation errors.
  • Increased uptake has been identified in extracerebral structures such as face, scalp and bone in some cases. Residual activity in the midsagittal sinus can be sometimes observed.

Important Safety Information

Risk for Image Interpretation and Other Errors

Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F). A negative scan indicates sparse or no density of cortical β-amyloid plaques. A positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.

Radiation Risk 
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 5.8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability.

Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle. Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing. Common adverse reactions include injection site pain and injection/ application site erythema.

For more information please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/neuraceq 

About Life Molecular Imaging (LMI) 
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. The organization 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 Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/

For media queries contact:

Brittany Hahn |
Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |  b.hahn@life-mi.com 

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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