Siemens’ PETNET Solutions and Lilly Sign Amyvid EU Manufacturing Agreement
PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., will soon begin manufacturing Eli Lilly and Company’s AmyvidTM (Florbetapir (18F)) radiopharmaceutical in the United Kingdom, as well as in Spain and France, after signing a manufacturing services agreement with Eli Lilly and Company. Siemens’ PETNET Solutions will function as a contract manufacturer for Lilly after Lilly’s diagnostic radiopharmaceutical received marketing authorisation from the European Commission in early 2013.
Amyvid (Florbetapir (18F)) solution for injection is a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. The first commercial doses of Amyvid produced by Siemens’ PETNET Solutions are expected to begin in the UK this summer. Commercial supply from Siemens’ PETNET Solutions locations in Spain and France is expected to start by the end of 2013 and in 2014, respectively, pending regulatory approval of these sites.
The manufacturing agreement with Lilly follows significant investments by Siemens' PETNET Solutions to standardise equipment and processes throughout its global network, including new automated processes and redundant equipment to serve clinical research demands and immediate patient needs. Siemens’ PETNET Solutions is already the largest manufacturer and distributor of Amyvid in the United States.
“This agreement with Lilly is another proof point that Siemens is at the forefront of providing leading PET imaging solutions to fight against the most challenging diseases such as Alzheimer’s disease,” states Dr. Christoph Zindel, CEO of PETNET Solutions. “With our investments into our network over the last several years and our experience manufacturing Amyvid in the USA, we are confident that we will provide our customers in Europe the same level of high delivery reliability as our customers have come to expect from PETNET Solutions.”
About Siemens PETNET Solutions
PETNET Solutions is a wholly owned subsidiary of Siemens Medical Solutions
USA, Inc. complementing one of the most comprehensive molecular imaging portfolios in the industry including imaging equipment for clinical settings and preclinical research, cyclotrons and radiochemistry modules.
About Amyvid
Amyvid (Florbetapir (18F)) solution for injection is the first-and-only radioactive diagnostic agent approved for use in the United States and European Union for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques. A negative Amyvid scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. A positive scan indicates moderate to frequent plaques, but does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson’s disease dementia). Developed by Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, Amyvid is an adjunct to other diagnostic evaluations. Only a qualified physician can establish diagnosis of AD based on results of a comprehensive patient assessment.