PRESS RELEASE

CMI Inc. and Life Molecular Imaging Announce the Reimbursement of the Amyloid-PET Diagnostic Neuraceq® (florbetaben 18F) in Japan

First Reimbursed Amyloid PET Diagnostic Tool in Japan

Tokyo, Japan / Berlin, Germany, November 22, 2023 – CMI Inc. and Life Molecular Imaging (LMI) are pleased to announce that the amyloid-PET diagnostic  Neuraceq® (florbetaben 18F injection) has been approved from the Ministry of Health, Labor, and Welfare to be reimbursed by governmental health insurance. With this C2 path approval, Neuraceq®–PET is the first amyloid PET diagnostic tool currently reimbursed in Japan. Neuraceq® is available in Japan from the approved medical device 放射性医薬品自動合成装置Synthera+ (PMDA medical device license no. 30100BZX0016900) and is currently accessible at Keio University Hospital, Tokyo, Koseikai Takeda Hospital, Kyoto and Uozumi Clinic, Kumamoto. CMI Inc. plans to set up Neuraceq® production at further hospital radiopharmacy sites.

With the reimbursement of this diagnostic tool, Japanese physicians can use this state-of-the-art imaging technology to accurately evaluate their patients with cognitive decline. The density of amyloid plaques can be assessed to improve an earlier diagnosis, and to further guide therapy and patient management.

After the recent approval of Eisai’s Alzheimer’s disease (AD) modifying drug LEQEMBI® in Japan, an accurate and reliable diagnosis of AD is critical to access this new therapy. Amyloid PET, including also Neuraceq®, had a pivotal role in the recent positive clinical study outcomes of new anti-amyloid drugs by making selective inclusion of patients with confirmed amyloid pathology in the brain in the trials feasible. Moreover, amyloid clearance was precisely measured with amyloid PET.

“Achieving reimbursement for amyloid PET using Neuraceq® in Japan is an important milestone. We are pleased that our amyloid PET tracer, a very important and reliable diagnostic imaging agent, is now available for more Japanese patients,” said Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging.

“LMI is committed to expanding global market access of Neuraceq®. We will continue to work with our partner CMI in Japan to improve the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer’s disease, and to making Neuraceq® available to more referring physicians across the country,” said Colleen Ruby, Chief Operating Officer, Americas and APAC at Life Molecular Imaging.

“CMI is intensively working for PET facilities in Japan and we are encouraging them to deliver amyloid-PET using Neuraceq® to patients with possible Alzheimer’s disease so that they may have an opportunity to reach advanced therapeutic drugs,” said Yasuhisa Fujibayashi, Chief Technology Officer, CMI Inc.

For more information in Japanese, please read the CMI press release:

https://www.cmi-jpn.co.jp/wp-content/uploads/20231122PR.pdf

About Neuraceq Automated Synthesizer Synthera+® (florbetaben 18F)
Indication approved in the Japan
Neuraceq® is a radioactive diagnostic agent 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 of Use

  • A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions, or (ii) monitoring responses to therapies.

Important Safety Information (as approved in Japan)

Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. 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.

Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. Adverse Reactions occurring with a frequency of more than 1% include injection/application site erythema, injection site irritation and injection site pain.

For more information please visit: https://neuraceq.com 

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 Life Healthcare Group. 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 CMI Inc.
CMI Inc imports and sells highest quality products such as cyclotron system, automatic PET drug synthesizer, auto dispensing system and so on.  CMI also supports planning, development and operation of clinical as well as research facilities for Positron Emission Tomography (PET) and contributes to the progress and expansion of Japanese medical field.  Learn more at https://www.cmi-jpn.co.jp

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 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection. Learn more at https://www.lifehealthcare.co.za/

For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 |

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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