Improved supply capabilities of Neuraceq® to provide access to Amyloid-PET to patients in the wider Balkans
BERLIN and LAVRIO, Greece, July 19, 2022 /PRNewswire-PRWeb/ -- Life Molecular Imaging (LMI) and BIOKOSMOS SA announced today that both companies have entered into a strategic partnership and licensing agreement providing BIOKOSMOS with rights to manufacture and distribute Neuraceq® in Greece, Bulgaria, North Macedonia and Albania.
BIOKOSMOS SA will start manufacturing Neuraceq® in their manufacturing sites in Athens and Thessaloniki, Greece, as soon as the necessary authorisations from the relevant authorities have been obtained.
Neuraceq® is an approved imaging agent for the detection of beta-amyloid plaques in the brain that is used in clinical routine. It is also a powerful imaging biomarker for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases.
"With the addition of four countries, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain. We are truly excited about this collaboration with BIOKOSMOS to make our approved amyloid tracer Neuraceq® even more available to physicians and our pharma partners for routine clinical and research use" said Ludger Dinkelborg, Ph.D., Managing Director at LMI.
"It is a great pleasure to have signed this important manufacturing and distribution agreement with Life Molecular Imaging" – declares Angelos Pagonis, President of the Board and CEO at BIOKOSMOS. "Our strategic partnership with LMI will expand the availability of the innovative molecular imaging agent Neuraceq®, to patients of the wider Balkan region, contributing to the fight against Alzheimer's disease and other causes of cognitive decline".
About Neuraceq (florbetaben 18F)
Indication
Neuraceq® is a radioactive diagnostic agent indicated 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.
A negative Neuraceq® 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 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 and (ii) monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Neuraceq® can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq® is an adjunct to other diagnostic evaluations. Neuraceq® images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
Radiation Risk
Administration of Neuraceq®, like 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. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 1077 subjects with 1295 Neuraceq® administrations were injection/application site erythema (1.4%), and injection site pain (3.1%).
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/
About BIOKOSMOS SA
BIOKOSMOS SA was founded in 1992, providing high level services and solutions in the field of Nuclear Medicine and Oncology. Today, BIOKOSMOS is a key radiopharmaceutical manufacturer with two manufacturing sites in Greece, one in Athens and the other in Thessaloniki, and has established a comprehensive distribution network, fully covering the needs of the wider Balkan region for innovative radiopharmaceuticals in Molecular Imaging and in Oncology.
For more information visit: https://www.biokosmos.gr/ and follow BIOKOSMOS on LinkedIn.
For media queries
Alya Schalabi | Marketing Europe | Life Molecular Imaging
Tel#: +49 151 1456 9895 | [email protected]
Media Contact
Alya Schalabi, Life Molecular Imaging, 49 30461124603, [email protected]
SOURCE Life Molecular Imaging
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