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Piramal Imaging Announces Strategic Partnership with PositronPharma for Manufacturing and Distribution of Neuraceq™ in Chile

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Piramal Imaging SA and PositronPharma today announce that the companies have entered into a strategic partnership and licensing agreement to provide PositronPharma with rights to manufacture and distribute Neuraceq (florbetaben F18 injection) throughout Chile. 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.

 


 

BERLIN/BOSTON, March 26, 2018 – Piramal Imaging SA and PositronPharma today announce that the companies have entered into a strategic partnership and licensing agreement to provide PositronPharma with rights to manufacture and distribute Neuraceq (florbetaben F18 injection) throughout Chile. 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.

Alzheimer’s disease, a condition that slowly destroys memory and cognitive abilities, currently affects more than 188,000 people in Chile, according to the latest national survey on dependency in the elderly from 2014.1  Until today, an estimated 20-30% of patients with dementia have been misdiagnosed and often experienced extended diagnostic episodes before receiving a clinical diagnosis.Historically, a definitive diagnosis of Alzheimer’s disease could only be made after death, based on autopsy findings of beta-amyloid plaques and neurofibrillary tangles in the brain. Today, a comprehensive clinical evaluation in combination with in-vivo biomarkers, such as beta-amyloid PET imaging, can improve the diagnostic accuracy, allowing for improved patient management and access to Alzheimer’s drug trials.

“Alzheimer’s disease is a severe problem for the Chilean population. In 2017 our government adopted a national plan on dementia which includes improving access to care, support, treatment and research,” said Horacio Amaral, President of PositronPharma. “The partnership with Piramal Imaging, and bringing Neuraceq beta-amyloid PET imaging to Chile, supports this common goal and adds to our commitment to provide the best diagnostic options for our patients.”

“Piramal Imaging continues to expand its manufacturing and distribution network to bring Neuraceq into new markets,” said Ludger Dinkelborg, Director of the Board, Piramal Imaging. “The partnership with PositronPharma demonstrates our commitment to further expanding our global presence, and increasing access to beta-amyloid PET imaging for imagers and referring physicians to advance the accuracy of clinical diagnosis in Alzheimer’s disease.”

 About Neuraceq (florbetaben F18 injection)

Indication

Neuraceq™ (florbetaben F18 injection) 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 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:
    • Predicting development of dementia or other neurologic conditions;
    • Monitoring responses to therapies.

 

Important Safety Information

Risk for Image Interpretation and Other Errors

Neuraceq can be used to estimate the density of β-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 Piramal Imaging SA

Piramal Imaging SA, a division of Piramal Enterprises, Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging 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. For more information please go to www.piramalimaging.com.

About PositronPharma SA

PositronPharma SA was founded in 2010 and is the leading provider of PET radiopharmaceuticals in Chile. By introducing cutting-edge technology and new radiopharmaceuticals PositronPharma aims to support PET centers, physicians and their patients with best-in-class products allowing for early detection, characterization and treatment of life threatening diseases. As part of this commitment PositronPharma also supports different clinical trials and investigator sponsored studies in the field of oncology and neurodegenerative disorders.

 


1 The Chilean Istitute of Public Health, National Mental Health Plan page 12

2 Speechly CM, Bridges-Webb C, Passmore E. The pathway to dementia diagnosis. Med J Aust. 2008;189(9):487-9.

 

 

 

 

Matthias Herth

Primer coloquio de neuroimágenes con PET en 2013

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Coloquio de Medicina Nuclear:

Radiofármacos para neuroimágenes con PET

Dr. Vasko Kramer, Positronpharma S.A.
Ligands for pre- and postsynaptic imaging of the dopaminergic system in
 neurodegenerative disorders by PET

Dr. Matthias Herth, Center for Integrated Molecular Brain Imaging,
Rigshospitalet and University of Copenhagen
Neuo-PET ligand development: From medicinal chemistry to human PET
studies

  • Fecha: 14 de Febrero 2013 de 18:00 a 19:30
  • Lugar: Auditorio de la Fundación Arturo Lopez Perez, Rancagua 878, Providencia, Santiago
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Dr. Matthias Herth

Matthias HerthCenter for Integrated Molecular Brain Imaging, Rigshospitalet and University of Copenhagen, and Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copen

Systematic Development Approaches for Novel PET Tracers 1) A case study for the development of a 5-HT7 brain receptor ligand  2) Design of in vivo click imaging agents

1) A successful in vivo imaging probe for neuroreceptors possesses a range of properties including high selectivity for the target of interest, the ability to reach the target site, low nonspecific binding, suitable affinity such that a large enough specific-to nonspecific signal exists, suitably reversible kinetics to facilitate quantitative analysis, and the ability to be radiolabeled. Given these numerous and sometimes conflicting characteristics, it is not surprising that the discovery and development process is challenging. To date, the process usually concentrates on screening compounds according to lipophilicity, affinity, selectivity and labeling feasibility. The weakness of these approaches is that only some of the characteristics required are considered, with little deliberation given to the prediction of nonspecific binding and optimal kinetics. In this talk, I want to present the development design which we have applied for a 5-HT7 tracer and which strategies we want to implement in the future.

2) Developing new approaches for diagnosing and treating cancer as well as neurodegenerative brain diseases currently remain major tasks for our society and current healthcare systems. Promising approaches to develop efficient therapies or to explore molecular basis of various diseases are hampered by missing long-term in vivo clinical imaging techniques. PET (Positron Emission Tomography) is an appropriate tool to image in vivo long-term drug interactions. But current methods apply long-lived radionuclides and are thus inadequate for clinical long-term PET imaging. Major drawbacks are high absorbed radiation doses and restricted patient mobility. In this talk, I want to show possibilities to circumvent this problem using in vivo click imaging strategies. A short state of the art review and an overview of my future research plan will be presented.

Ciclotron

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Experiencia médica y alta tecnología caracterizan a la Fundación Arturo López Pérez en su labor contra el cáncer.

Hoy, esta mirada se fortalece con la renovación de su Centro de Medicina Nuclear, que permite detectar tumores de hasta dos milímetros gracias a los radiofármacos que produce un Ciclotrón de 24 toneladas, alojado en un sólido búnker.

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