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Nymox Obtains CE Mark for AlzheimAlert Test Kit; Product Now Available in Europe Related Stocks
NYMX
MAYWOOD, N.J.--(BUSINESS WIRE)--Nov. 8, 2004--Nymox Pharmaceutical Corporation (NYMX - news) is pleased to announce the certification of its AlzheimAlert(TM) test kit with a CE Mark, making the device eligible for sale in the European Union. The Company announced today that it has now fulfilled the required regulations which will allow European clinical and hospital laboratories to perform the AlzheimAlert(TM) test in their own facilities in Europe.
Under the European IVD Directive, certain products must meet regulatory requirements in order to qualify for sale and distribution in the European Union. The CE Marking indicates that a product complies with EU safety, environmental, and quality standards. Nymox has satisfactorily completed the testing and registration required to obtain CE Marking for the AlzheimAlert(TM) test kit device.
"This is an important milestone for the firm," said Brian Doyle, Nymox's Senior Manager for Worldwide Sales and Marketing. "We anticipate that the launch of the kit version of our AlzheimAlert(TM) test will open important new markets for the company. Alzheimer's disease is a public health problem of growing magnitude in Europe as populations age. Our AlzheimAlert(TM) technology targets an enormous unmet need - the early, accurate and cost-effective diagnosis of Alzheimer's disease."
"Nymox has the highest commitment to quality and safety" said Jack Gemmell, General Counsel of Nymox. "Obtaining the CE Mark secures our presence in the European Union marketplace."
The NTP test is a non-invasive urine test intended to help physicians in the diagnosis of Alzheimer's disease. The test measures the level of a brain protein called neural thread protein (NTP) known to be elevated in the urine of patients with Alzheimer's disease. There is an extensive scientific and medical literature on NTP and its relationship to Alzheimer's disease and on its clinical accuracy and utility as an aid to the diagnosis of Alzheimer's disease. Publications include, for example, Journal of Alzheimer's Disease (2004; 6(3): 231-42) and (2001; 3: 345-353); Cellular and Molecular Life Sciences (2003; 60: 2679-91) and (2001; 58: 844-849); Alzheimer's Reports (2002; 1: 1-6); Neurology & Clinical Neurophysiology (2002; 1: 2-7); Frontiers in Bioscience (2002; 7:d989-96); Journal of Neuropathology and Experimental Neurology (2001; 60: 195-207) and (1996; 55: 1038-1050); Neurology (2000; 55: 1068) and (2000; 54: 1498-1504); Alzheimer's Reports (2001; 4: 61-65), (2000; 3: 177-184) and (1999; 2: 327-332); Journal of Clinical Laboratory Analysis (1998; 12: 285-288) and (1998; 12: 223-226); Journal of Contemporary Neurology (1998; 4A: 2-6); and Journal of Clinical Investigation (1997; 100: 3093-3104).
According to a recent study (Arch Neurol August 2003; 60: 1119-1122), there are 4.5 million people with Alzheimer's disease in the United States alone; by 2050 this number is projected to increase almost three times to 13.2 million. Worldwide estimates of the current number of people with Alzheimer's disease range from 15 to 20 million. The annual national direct and indirect costs of caring for Alzheimer patients in the U.S. alone is estimated at $100 billion. The human toll on patients, families and caregivers is incalculable.
Nymox Pharmaceutical Corporation is a biotechnology company engaged in the research and development of therapeutics and diagnostics, with a particular emphasis on products targeted for the unmet needs of the aging population. Currently Nymox has three products on the market, and a healthy pipeline of drug and diagnostic products. The Company also has several hundred patents and patent applications. Nymox offers AlzheimAlert(TM), a test to aid in the diagnosis of Alzheimer's disease. The Company is conducting pivotal Phase II clinical trials for NX-1207 a drug for benign prostatic hyperplasia (BPH). The Company markets NicAlert(TM) and TobacAlert(TM) tests for measuring tobacco product exposure. Nymox has a number of drugs in development for Alzheimer's disease, oncology, and infectious disease.
More information about Nymox is available at
www.nymox.com, email:
info@nymox.com, or 800-936-9669.
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