Piramal Imaging Release: Neuraceq(™) (Florbetaben F18 Injection) Data: An Emerging Science Topic At The American Academy of Neurology Annual Meeting In Philadelphia
Published: Apr 30, 2014
BERLIN, GERMANY and BOSTON, MA and MUMBAI, INDIA--(Marketwired - April 30, 2014) - Piramal Imaging today announced that data from its beta-amyloid PET tracer Neuraceq™ clinical trial will be featured as part of Emerging Science sessions at the 66th American Academy of Neurology Annual Meeting at the Pennsylvania Convention Center Philadelphia, Penn.
A presentation by Marwan Sabbagh MD, FAAN, director of the Banner Sun Health Research Institute Research and Professor of Neurology at the University of Arizona, will focus on the diagnostic accuracy of Neuraceq™ as confirmed in a histopathology clinical trial that was central to the recent US and EU approvals. This should encourage physicians to search for other causes of cognitive decline and tailor available treatment options.
"The research and testing that showed efficacy and safety of Neuraceq™ was both exhaustive and rewarding," said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. "The results of our histopathology analysis show a high level of correlation between tracer uptake and presence of beta-amyloid pathology."
To qualify for one of 10 spots in the Emerging Sciences session, the presented research must be "new and of sufficient scientific importance to warrant expedited presentation and publication." This presentation, will take place Wednesday, April 30, at 6:15 p.m.
Neuraceq™ was approved by the FDA on March 19, 2014, and in the EU on February 20, 2014. It is 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.
Important Safety Information
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 positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
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 978 Neuraceq administrations were injection/application site erythema (1.7%), injection site irritation (1.2%), and injection site pain (3.9%).
About Piramal Imaging
Piramal Imaging, 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.piramal.com/imaging.
About Piramal Enterprises, Ltd.
Piramal Enterprises (PEL) is one of India's largest diversified companies, with a presence in pharmaceuticals, financial services and healthcare information management sectors. PEL had consolidated revenues of over $650 million in FY2013. In the pharmaceutical space, PEL is one of the leading custom manufacturing players globally, has presence in the global critical care segment with a portfolio of inhalation and injectable anesthetics and its OTC business is ranked no. 7 in India. PEL is also engaged in drug discovery and research, and has a strong pipeline of development products. In the financial services space, PEL has a real estate focused PE fund -- Indiareit, and a NBFC that is focused on lending to the real estate and education sectors. PEL's healthcare information management business, Decision Resources Group, is a leading provider of information-based services to the healthcare industry.
About Banner Sun Health Research Institute
For 26 years, Banner Sun Health Research Institute, part of nonprofit Banner Health, has been a leader nationally and internationally in the effort to find answers to disorders of aging including Alzheimer's and Parkinson's disease. The institute, together with its Arizona Alzheimer's Consortium partners, has been designated by the National Institutes of Health as one of just 29 Alzheimer's disease Centers in the nation. The institute's Cleo Roberts Center for Clinical Research takes laboratory discoveries to clinical trials that foster hope for new treatments. Banner Health is Arizona's leading health care provider and second largest private employer. For more information, visit www.bannershri.org.
For media inquiries, please contact:
Emily Fisher - PR
Piramal Enterprises - Imaging Division