MATRAN, Switzerland, June 2, 2015 /PRNewswire/ -- Piramal Imaging SA and Ci-Co Healthcare today announce that the companies have received marketing authorization by the Ministry of Food and Drug Safety (MFDS) and the National Evidence-based Healthcare Collaborating Agency (NECA) for the commercial production and market supply of Neuraceq™ (florbetaben F18 injection) in Korea. Neuraceq is the first diagnostic radiotracer to support the early diagnosis of Alzheimer's disease (AD) that is commercially available in the country.
This announcement follows approval from the New Health Technology Assessment (nHTA) and the Korean Dementia Association (KDA) earlier this year. Previously, Neuraceq availability in Korea was limited to investigational medicine purposes.
"The commercial availability of Neuraceq will provide physicians throughout Korea with a non-invasive method to more confidently and accurately assess cognitively impaired patients for early diagnosis of Alzheimer's disease," said Professor Park MY, Yeungnam University Medical Center and chairman of the KDA. "In the absence of an approved disease modifying treatment, advancing our ability to make an early and accurate AD diagnosis is critically important to providing adequate symptomatic treatment and non-pharmacological measures to manage disease progression and quality of life of these patients."
Neuraceq has received approval by the FDA and EMA and is a diagnostic radiotracer that when used in combination with positron emission tomography (PET) imaging, can identify beta-amyloid plaques in the human brain, which are known as an important biomarker for Alzheimer's disease.
"We are very pleased to bring this very important diagnostic imaging tool to new markets like Korea," said Dr. Ludger Dinkelborg, Member of the Board, Piramal Imaging. "Piramal Imaging is committed to expanding global market access to Neuraceq and we will continue to partner with local distributors and GMP manufacturers like Ci-Co Healthcare and DuChemBio in Korea to advance the detection of Alzheimer's disease for imaging and referring physicians across the world."
About Neuraceq™ (florbetaben F18 injection)
Neuraceq is a diagnostic radiotracer that when used in combination with positron emission tomography (PET) imaging, can identify neuritic beta-amyloid plaques in the human brain, which are known as an important biomarker for Alzheimer's disease. It is approved in the USA, EU and Korea. For details concerning its use and limitations in the interpretation of positive scans, please refer to the respective PIs.
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.piramal.com/imaging.
About Ci-Co Healthcare Co., Ltd.
Ci-Co Healthcare, based in Seoul, Korea, was established in 1993. For the past 20 years Ci-Co Healthcare has partnered with the laboratory medicine departments of more than 300 hospitals across the country, supplying them with in-vitro diagnosis devices, including immunology and biochemistry, on-site emergency inspection systems, and Siemens laboratory automation systems. For more information, please visit http://www.cicohealthcare.com.
About DuChemBio Co., Ltd.
DuChemBio Co., Ltd., established in 2002, is a leading company operating the largest radio-pharmacy network (6 cyclotrons) in Korea, and is currently installing a cyclotron center in Manila, Philippines to supply a variety of radiopharmaceuticals. Having the confidence that "the true meaning of healthcare corresponds with early diagnosis as well as timely treatment based on early and accurate diagnosis," DuChemBio continues to focus on diagnosis-related businesses with the acquisition of an in-vitro diagnosis distribution company in Korea in April 2012, and with the plan to expand its business to East Asian markets as a company specialized in radiopharmaceuticals.
SOURCE Piramal Imaging