Collaboration Initiated for PET Imaging Agent Manufacturing

Imaging biomarker production is set to expand the availability of a molecular imaging agent for positron emission tomography (PET) imaging of beta-amyloid deposits in the brain, a key pathologic component of Alzheimer's disease (AD) for clinical studies in the United States.

Avid Radiopharmaceuticals, Inc. (Philadelphia, PA, USA) and PETNET Solutions, Inc. (Knoxville, TN, USA), a wholly-owned subsidiary of Siemens Medical Solutions, USA, Inc. (Ann Arbor, MI, USA), marked the first dose shipped from a PETNET Solutions manufacturing facility as part of its collaboration with Avid on Florbetapir F18 (18F-AV-45), Avid's molecular imaging agent PET imaging of beta-amyloid deposits.

Florbetapir is currently being evaluated for brain PET imaging of beta-amyloid in clinical studies of patients with suspected 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 United States, 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, M.D., Ph.D., 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 healthcare 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 beta-amyloid imaging compound to enter multicenter, IND (Investigational New Drug) clinical studies in the United States, 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 United States is nearing completion, and the compound is currently in additional clinical studies in the European Union, South America, Australia, and Asia.

Avid Radiopharmaceuticals is a developer of molecular imaging products with the potential for earlier and more effective detection, diagnosis and monitoring of major chronic human diseases. 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 beta-amyloid plaque build-up in the brain. Avid is currently conducting phase III clinical studies of Florbetapir (18F-AV-45), for imaging beta-amyloid plaques in AD, 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).

The Siemens Healthcare Sector (Erlangen, Germany) 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.

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Avid Radiopharmaceuticals
PETNET Solutions
Siemens Healthcare