|By Marketwired .||
|June 6, 2014 11:17 AM EDT||
BERLIN, GERMANY and BOSTON, MA and MUMBAI, INDIA -- (Marketwired) -- 06/06/14 -- Piramal Imaging today announced that 12 presentations at the Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), being held June 7 - 11 at the St. Louis Convention Center in St. Louis, Mo., will highlight research key to Piramal's product and pipeline.
The presentation topics will include research central to the recent FDA and EU approval of Neuraceq (florbetaben F18 injection) as well as insights into its clinical application and advancements relative to the company's oncology and cardiovascular imaging related pipeline. The findings will be presented by an international field of scientists, including researchers from Columbia University, New York; University of Leipzig, Germany, and Molecular NeuroImaging, New Haven.
Additionally, Piramal Imaging will host its own scientific symposium with Christopher Rowe, MD FRACP, from the University of Melbourne, Melbourne, Australia, Marwan N. Sabbagh, MD FAAN, from Banner Sun Health Institute, Phoenix, Arizona, and Val Lowe, MD FACS, from Mayo Clinic, Rochester, Minnesota, presenting information and facilitating discussion about "Amyloid Imaging - A Window into Cognitive Impairment."
"As a company devoted to innovation in the Molecular Imaging field, Piramal Imaging is committed to working on cutting-edge science with top researchers from around the world," said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. "As a result, our research will be a centerpiece of this year's SNMMI conference, underscoring the rigor of the science behind Neuraceq, adding to the body of evidence of the value of beta-amyloid imaging and previewing some of the potential of our pipeline."
"Research and development is at the core of innovation," said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises, Ltd. "SNMMI is a great opportunity to focus on the important role the research community plays in advancing the state of the art in Molecular Imaging. At Piramal, we've been able to team with researchers from around the world on the science behind our current and future products and look forward to the discussions and new ideas their work will foster at the show."
Research relating to Piramal Imaging's product and pipeline will be discussed throughout the Annual Meeting. Below are more details on the line-up:
- Eight oral presentations being included as part of the Scientific Papers series. Five talks including florbetaben data will take place during the following sessions: "AD I: Preclinical to Clinical" (Monday, June 9 - 12:30 p.m., Room 226), "AD II: Advanced Approaches" (Monday, June 9 - 4:45 p.m., Room 226), and "Neurosciences: Preclinical Models" (Tuesday, June 10 - 2:45 p.m., Room 226). New data from Piramal Imaging's compounds for cancer and cardiovascular imaging will be presented during the following sessions: "Prostate Cancer: PSMA-based and other new tracers" (Sunday, June 8 - 12:30 p.m., Room 229), "Probes for Cardiovascular, Endocrine, and Other I" (Tuesday, June 10 - 10:00 a.m., Room 232), and "Breast and lung cancer" (Tuesday, June 10 - 4:30 p.m., Room 230).
- Four posters including florbetaben data will be presented during "MTA II: Neurology Posters" and "MTA II: Neurosciences - Basic Science Posters" (Tuesday, June 10, 2:45, Exhibit Hall 5).
Neuraceq was approved in the US and EU earlier this year. Neuraceq 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.
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 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.
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.
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