Company Contact: John F. DeBernardis, Ph.D., President & CEO
Investor Contact: Ira Weingarten/Steve Chizzik
Media Contact: Jeff Siegel, Monarch Communications
Applied NeuroSolutions Takes First Step In
Commercialization of Diagnostic Alzheimer’s Disease Test
Company Begins Process with FDA
Vernon Hills, IL, September 08, 2005 -
Applied NeuroSolutions, Inc. (OTC BB: APNS, www.appliedneurosolutions.com) today announced that it has submitted a pre-IDE (Investigational Device Exemption) application with the FDA, a milestone in the process of commercializing its cerebrospinal fluid (CSF) diagnostic Alzheimer's disease (AD) test.
The pre-IDE application process is designed to provide companies that have unique diagnostic tests with informal input regarding what the FDA would look for in a formal IDE application.
“We're excited to submit our pre-IDE and begin to get important feedback that will allow us to move forward in our quest to bring our CSF AD diagnostic test to market,” said Dr. John DeBernardis, President and CEO of Applied NeuroSolutions.
A recent report by industry research firm Datamonitor Solutions said that the US and Europe could have a combined two million candidates to take the test each year, Dr. DeBernardis added, forming a very large potential market.
As part of its effort to bring an AD test to market, Applied NeuroSolutions has formed an advisory committee to assist in the actual IDE filing, noted Dr. DeBernardis. The six-person committee includes some of the best and brightest in Alzheimer's disease research, led by Applied NeuroSolutions' founding scientist, Dr. Peter Davies, the Judith and Burton P. Resnick Professor of Alzheimer's Disease Research at Albert Einstein College of Medicine.
“The submission of our pre-IDE application is the first step in a process towards commercialization,” commented David Ellison, Applied NeuroSolutions CFO. “We anticipate the next steps to include meetings with the FDA and our advisory committee to review and further refine our protocols. Following these meetings, we anticipate filing our IDE and beginning clinical trials in the first quarter of 2006.”
Applied NeuroSolutions, Inc. is developing products to diagnose and treat Alzheimer's disease based on a novel hypothesis of AD pathology. In partnership with Dr. Peter Davies and a scientific team at Albert Einstein College of Medicine, Applied NeuroSolutions has developed a cerebrospinal fluid (CSF) test to detect Alzheimer's disease at a very early stage with 85%-95% accuracy in more than 3,000 patient samples. There are approximately 2 million new patients annually worldwide who are candidates for an AD CSF diagnostic test, according to Datamonitor. In the U.S. alone, Datamonitor projects an $80 to $160 million annual market potential. The company is also developing a blood serum-based screening test, as well as a new class of therapeutics to treat AD. Alzheimer's disease currently afflicts over 4 million Americans, and the market for AD therapy is expected to grow to 21 million patients by 2010 in the seven major pharmaceutical markets (USA, France, Germany, Italy, Spain, U.K. and Japan) according to BioPortfolio, Ltd.
There are currently no FDA-approved diagnostic tests to detect Alzheimer's disease.
This press release contains forward-looking statements. Applied NeuroSolutions wishes to caution the readers of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, the risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, potential competitive offerings, and access to capital. For further information, please visit the company's website at www.appliedneurosolutions.com, and review the company's filings with the Securities and Exchange Commission.