Apr 8 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 β-amyloid deposits in the brain, a key pathological component of Alzheimer's disease.
“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.”
Florbetapir is currently being evaluated for brain PET imaging of β-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 β-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.
Source Avid Radiopharmaceuticals, Inc.