PRESS RELEASE

Life Molecular Imaging and Oryx Isotopes Industrial Company announce a Strategic Partnership for the Production and Distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other countries in reach

 

Improved supply capabilities of Florbetaben (18F) to provide further access to Amyloid-PET to patients throughout the Middle East and North Africa (MENA) region 

 

Berlin, Germany and Dammam, Kingdon of Saudia Arabia, February 6, 2024 – Life Molecular Imaging (LMI) and Oryx Isotopes Industrial Company (Oryx) have announced a strategic partnership for the production and distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other reachable countries, aiming to enhance the supply of this tracer for Amyloid-PET imaging in the Middle East and North Africa (MENA) region.

The partnership grants Oryx the rights to manufacture Florbetaben (18F) at their Dammam production facility and distribute it in Saudi Arabia and nearby regions.

Oryx is set to commence manufacturing once the technical setup is finalized.

“Establishing this crucial manufacturing and distribution agreement for the production of Florbetaben (18F) will broaden access to Amyloid-PET through our innovative molecular imaging agent for patients in the Middle Eastern Region”, said Ludger Dinkelborg, Ph.D., Managing Director at LMI, and added that “the strategic collaboration with Oryx Isotopes will contribute significantly to combating Alzheimer’s disease and other causes of cognitive decline.”

“The collaboration between LMI and Oryx Isotopes will bring excellent opportunities for the Alzheimer’s Disease patients in Saudi Arabia and the region to be diagnosed earlier and thus treated with more efficiency. Oryx Isotopes is very enthusiastic for being the first company in GCC to produce F18FBB.” Dr. Husain Ahmed (Head of Board) and Dr Aiman Alnahawi (CEO) stated “We are driven by a passion for improving patient care and are dedicated to advancing the field of nuclear medicine through groundbreaking research and the development of novel therapies; definitely our collaboration with LMI will have a significant impact on patients and their relatives quality of life.”

About Florbetaben (18F)*
Florbetaben (18F) 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 Florbetaben (18F) 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 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 05/2023)

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centred, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, 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 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/

About Oryx Isotopes Industrial Company (Oryx)
Oryx Isotopes was established in 2021 in the eastern province of Saudi Arabia. The company is proud with its certifications (GMP, ISO9001: 2015, and NRRC) which ensure the quality of products and services and safety of the environment. Oryx Isotopes has emerged from leading companies which have long experiences in the field of radiopharmaceutical production, logistics, nuclear medicine management. It is driven by a set of great values, which are sufficiently reflected in all aspects of the business. Oryx Isotopes aims to enhance the “quality of life” for the patients and this objective will be achievable more with our partnership with LMI.

Since its commencement, Oryx Isotopes has grown to be a leading manufacturer for diagnostic and therapeutic radiopharmaceutical. Its powerful presence in the market is built by growing up our loyal customer not only in Saudi Arabia but also in the whole GCC countries. For more information, please visit our website: www.oryxisotopes.com

For media queries
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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