Life Molecular Imaging and Institut de Radiofarmàcia Aplicada de Barcelona (IRAB) Announce a Strategic Partnership for Production of NeuraCeq and PI-2620 in Barcelona

Barcelona, April 26, 2019 /PRNewswire-PRWeb/ -- Life Molecular Imaging (LMI) and the Institut de Radiofarmàcia Aplicada de Barcelona (IRAB) announced today the commercial production of NeuraCeq™ (florbetaben 18F) in Barcelona. The first doses were delivered yesterday to clinical sites for human use. Both companies have entered into a strategic partnership and licensing agreement providing IRAB with rights to manufacture and distribute NeuraCeq™ throughout Catalonia and Aragon. Until recently this region was served by Curium Pharma Spain under special arrangements and LMI would like to thank them for their efforts in the past to make this possible. In addition, the investigational Tau-PET tracer PI-2620 is made available from IRAB for clinical research studies. LMI and IRAB leveraged their joint resources to establish broader availability of both tracers for use in clinical and research examinations.

The combination of NeuraCeq™, the approved imaging agent for detection of beta-amyloid plaques, and the investigational PI-2620 tracer for the detection of tau pathology, provides a powerful imaging biomarker platform for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases.

"Life Molecular Imaging continues to expand the availability of innovative molecular imaging agents and we are truly excited through this collaboration with IRAB to better serve physicians and our pharma partners with both, our approved NeuraCeq™ for clinical routine, research and the investigational PI-2620 tau PET-tracer for clinical trials." said Ludger Dinkelborg, Ph.D., Managing Director at LMI.

Roger Rovira from IRAB added, "Teaming up with LMI on both, amyloid and tau PET tracers provides us the unique opportunity to better support clinicians with imaging biomarkers for neurodegenerative diseases in the Barcelona area as this is one of the leading biomedical research environments for Alzheimer's disease and other neurodegenerative diseases in Europe".

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™, 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. 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 872 subjects with 1090 NeuraCeq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).

About PI-2620
Tau deposits, in conjunction with beta-amyloid plaques, represent the other pathological hallmark of Alzheimer's disease, with tau deposits further playing an important role in other neurodegenerative diseases. PI-2620 is binding to tau deposits and is a next generation 18F-labeled investigational PET tracer with favourable properties and imaging characteristics. It was discovered in a research collaboration between Life Molecular Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company. Life Molecular Imaging has the exclusive, world-wide license for research, development and commercialization of tau PET tracers generated within the discovery program.

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
The Life Healthcare Group has more than 33 years' experience in the private healthcare and hospital industry. Headquartered in Johannesburg, South Africa, the Group is a listed company on the Johannesburg Stock Exchange. The company's primary business is private acute hospital care with 65 healthcare facilities in seven of South Africa's nine provinces and one hospital in Botswana, as well as providing services for acute physical rehabilitation, acute mental healthcare and renal dialysis. Life Employee Health Solutions services both occupational health and employee wellness to private and public employers. The Group includes an international presence through Alliance Medical Group (UK/Europe) and Scanmed S.A. (Poland). For more information visit lifehealthcare.co.za

About Institut des Radiofàrmacia Aplicada de Barcelona (IRAB)
IRAB was established in 2016 as a new radiopharmaceutical laboratory for production, marketing and development of PET radiopharmaceuticals (Positron Emission Tomography) as well as for the provision of diagnostic services for image and develop high value-added health applications for the biomedical and pharmaceutical sector in one of the leading biomedical research environments in Europe (Barcelona Biomedical Research Park), by providing service excellence and product reliability oriented to the existing and future needs based on radiopharmaceuticals.

Contact person from IRAB:
Roger Rovira
Director | Institut de Radiofarmàcia Aplicada de Barcelona (IRAB)
+34.933.160.983
[email protected]

For media queries
Nicole Fletcher | Marketing Communications | Life Molecular Imaging
Tel#: 857-202-1122 | [email protected]

SOURCE Life Molecular Imaging