PRESS RELEASE

Life Molecular Imaging and Advanced Medical Support Announce a Strategic Partnership for the Production of Florbetaben (18F) at the American University of Beirut Medical Centre, Lebanon

Improved supply capabilities of Florbetaben (18F) to provide access to Amyloid-PET to patients throughout the MENA region

Berlin, Germany and Beirut, Lebanon, 24 January 2023. Life Molecular Imaging (LMI) and Advanced Medical Support (AMS) announced today that both companies have entered into a strategic partnership and licensing agreement providing AMS with rights to have Florbetaben (18F) manufactured at the American University of Beirut Medical Centre (AUBMC) and to distribute the tracer in Lebanon, Jordan and other countries in the Middle East and North Africa (MENA).

AUBMC will start manufacturing Florbetaben (18F) at their manufacturing site in Beirut, Lebanon, as soon as the technical set-up is finalized.

“It is a great pleasure to have entered into this important manufacturing and distribution agreement with AMS to produce Florbetaben (18F) at the American University of Beirut, Lebanon” – declares Ludger Dinkelborg, Ph.D., Managing Director at LMI. “Our strategic partnership with AMS will expand the availability of the innovative molecular imaging agent Florbetaben (18F) to patients in the Middle Eastern and North African Region, contributing to the fight against Alzheimer’s disease and other causes of cognitive decline. “

“We are excited to have been selected by Life Molecular Imaging, as we are very proud of having a high end Cyclotron Facility at AUBMC who accepted to sign with us a long term agreement to make the beta-amyloid tracer Florbetaben (18F) available to physicians and patients in the Middle Eastern and North African Region“- says Charbel Bou Maroun, General Manager at AMS .

“In line with our vision for AUBMC to become a leading academic medical centre that strives to transform healthcare through state-of-the-art technology and research for the peoples of the Middle East and beyond, AUB has signed a memorandum of understanding with Life Molecular Imaging” – says Dr. Mohamad Haidar, M.D., Director of the Nuclear Medicine Division and Cyclotron Facility at the American University of Beirut Medical Centre. “This designates AUB as a reference centre in the region for the synthesis of Florbetaben (18F) for the diagnosis of early-stage Alzheimer’s disease. The AUB Cyclotron facility will deliver this radiotracer to the region, which not only serves its patients, but also aids in the growth of indications and the development of new procedures relating to beta-amyloid.”

About Florbetaben (18F)
Florbetaben (18F)* is a radioactive diagnostic agent used for Positron Emission Tomography (PET) imaging of the brain to estimate beta 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. [18F]florbetaben has been approved by the FDA and EMA for routine clinical use, and has local regulatory approval in other countries such as UK, Switzerland Japan, Korea and others.

A negative Florbetaben (18F) scan indicates sparse to no amyloid 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 Florbetaben (18F) 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. Florbetaben (18F) is an adjunct to other diagnostic evaluations.

Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).
* Source: US Neuraceq Prescribing Information, Revision 11/2022

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-centred, 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/

About Advanced Medical Support (AMS)
Headquartered in Beirut, Lebanon, is part of conglomerate medical device distributors including Levalis Pharma and Denmat DMCC. originally founded on 2008    , the company focus is radiopharmaceuticals and isotopes products with the Goal to become the most reputable and relevant nuclear medicine player in Lebanon and the Middle Eastern and African markets. 

About American University of Beirut Medical Centre (AUBMC)
AUBMC has been providing the highest standards of quality care to patients across Lebanon and the region since 1902. What started as a 200-bed capacity hospital is now an over 350-bed capacity medical center. The medical centre meets the health care needs of over 425,000 outpatient visits annually. AUBMC is dedicated to advancing the health of the community in Lebanon and the region through the delivery of exceptional and comprehensive quality care, excellence in education and training, leadership, and innovative research, while maintaining impactful outcomes, international accreditations, and ensuring accessible and sustainable services.

For media queries contact:

Alya Schalabi | Marketing Europe | Life Molecular Imaging
Tel#: +49 151 1456 9895 | a.schalabi@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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