PETNET production to expand availability of Florbetapir for clinical studies in the United States
Philadelphia, PA and Knoxville, TN, April 7 , 2010 – Avid Radiopharmaceuticals, Inc. (“Avid”) and PETNET Solutions, Inc. (“PETNET”), a wholly-owned subsidiary of Siemens Medical Solutions, USA, Inc. (“Siemens”, NYSE: SI), marked the first dose shipped from a PETNET Solutions manufacturing facility as part of its collaboration with Avid on Florbetapir F 18 (18F-AV-45 or Florbetapir), Avid’s molecular imaging agent for positron emission tomography (PET) imaging of ß-amyloid deposits in the brain, a key pathological component of Alzheimer’s disease.
Florbetapir is currently being evaluated for brain PET imaging of ß-amyloid in clinical studies of patients with suspected Alzheimer’s disease (AD) or mild cognitive impairment (MCI) in the United States and the European Union. PETNET Solutions operates the industry’s largest network of PET biomarker production facilities worldwide. PETNET manufactures Florbetapir at multiple facilities in the U.S. and continues to expand production capabilities to support the clinical development of Florbetapir.
“We are very pleased to be able to expand our clinical trial program by working with Siemens and PETNET on the manufacturing of Florbetapir for supply of our clinical trial sites throughout the U.S.,” said Daniel M. Skovronsky, MD, PhD, Avid’s President and CEO. “This partnership allows us to accelerate the development of Florbetapir and to extend our existing collaborations within the Alzheimer’s researcher community and the pharmaceutical industry, both of which are in pursuit of new tools for the early detection and management of Alzheimer’s disease.”
Siemens Healthcare, Molecular Imaging CEO Britta Fuenfstueck commented: “Siemens and Avid are organizations committed to changing the way chronic diseases are diagnosed and managed. Together, we share the view that new PET molecular imaging agents, such as Florbetapir, could have a major impact on health care for our aging population. We are pleased to be working with Avid on this exciting development and believe it fits well with our mission to deliver, expand, and advance the science of molecular imaging to the benefit of health care providers and their patients.”
Avid’s Florbetapir was the first ß-amyloid imaging compound to enter multi-center, IND clinical studies in the U.S., and has now been studied in more than a dozen trials in subjects ranging from cognitively normal individuals to those with Alzheimer’s dementia. A pivotal Phase III registration study which was initiated early last year in the U.S. is nearing completion, and the compound is currently in additional clinical studies in the E.U., South America, Australia and Asia.
About Avid Radiopharmaceuticals, Inc.
Avid Radiopharmaceuticals is a leader in the development of molecular imaging products with the potential for earlier and more effective detection, diagnosis and monitoring of major chronic human diseases. Based in Philadelphia, PA, the company is a pioneer in the development of molecular imaging agents for Alzheimer’s disease that could lead to earlier diagnosis and better evaluation of drugs designed to prevent or reverse ß-amyloid plaque build-up in the brain. Avid is currently conducting Phase III clinical studies of Florbetapir (18F-AV-45), for imaging ß-amyloid plaques in Alzheimer’s disease, and is in Phase I and II trials with 18F-AV-133 for imaging the vesicular monoamine transporter (VMAT2) in diseases involving dopaminergic degeneration (Parkinson’s disease and Dementia with Lewy Bodies) and beta cell dysfunction (Type I and Type II Diabetes Mellitus). More information about Avid is available at www.avidrp.com.
The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 48,000 employees worldwide and operates around the world. In fiscal year 2009 (to September 30), the Sector posted revenue of 11.9 billion euros and profit of around 1.5 billion euros. For further information please visit: www.siemens.com/healthcare.