Saturday, 14 November 2009

Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced today that it has initiated the U.S. launch of its high precision diagnostic test panel for the comprehensive evaluation of zinc and copper status in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI). The CopperProof Test Panel™ will be offered through the company's HartLab LLC clinical laboratory subsidiary and will provide a comprehensive look at the metabolic serum copper and zinc status of AD and MCI patients, which status has been shown to be impaired in this patient population. Defects in copper metabolism and high free copper levels are increasingly being recognized as significant factors in the progression of neurodegenerative diseases, including AD and MCI. A clinical zinc deficiency in AD patients has also been recognized for the first time in a recent Adeona-sponsored clinical study.

Adeona has hired a specialty sales force to bring the CopperProof Test Panel to neurologists, psychiatrists, gerontologists, nursing homes and other physicians that regularly treat patients with AD and MCI in selected key U.S. markets. The company will continue to build its specialty sales force with individuals having extensive experience calling on these physician practices and will expand its sales efforts to eventually cover the entire U.S. market. It is estimated that 25 million Americans suffer from Alzheimer's disease or cognitive impairment. The Alzheimer's Association estimates that $148 billion is spent each year caring for AD patients. Therapeutic products for AD and MCI represent an existing multi-billion dollar U.S. market. Current treatment solutions generally provide only symptomatic relief and are inadequate to halt the progression and devastating effects of AD and MCI, creating a significant market opportunity for new, potentially disease modifying solutions.

A teleconference call has been scheduled for 1:00p.m. EST today to discuss the product launch. Participants may join the teleconference by dialing 888-471-3841 just prior to 1:00p.m. EST. The passcode is 4751078. A replay of the teleconference will be available on Adeona's website for at least 15 days following the call.

On July 9, 2009 Adeona completed the acquisition of HartLab LLC, a CLIA-certified clinical reference laboratory located in Bolingbrook, Illinois. On July 15, 2009, Adeona presented the results of the CopperProof 1 Study, a prospective observational study comparing serum parameters of copper and zinc status in patients with Alzheimer's disease, Parkinson's disease and normal subjects, at the 2009 International Conference on Alzheimer's Disease (ICAD) in Vienna, Austria. This study showed a strong correlation between Alzheimer's disease and impaired serum copper binding as well as elevated percent free (non-ceruloplasmin bound) serum copper levels in AD patients. The study also reported, for the first time, clinical and subclinical zinc deficiency in AD patients.

The CopperProof Test Panel, developed at HartLab, will potentially identify patients with defective serum ceruloplasmin, elevated percentages of serum free copper level as well as zinc deficiency. Adeona believes that defects in copper metabolism and elevated percentages of serum free copper (non-ceruloplasmin bound) predisposes certain persons to enhanced susceptibility to the neurotoxic effects of copper, which include the aggregation, and reduced clearance, of oxidative copper in the beta amyloid plaques and neurofibrillary tangles, the hallmark brain pathologies of Alzheimer's disease (1-5). To learn more about the CopperProof Test Panel and HartLab, please visit www.hartlab.com.

On November 2, 2009, Adeona announced that it had received Institutional Review Board (IRB) approval to initiate a 60 patient, randomized, double-blind, placebo-controlled clinical trial of its patent pending Zinthionein™ ZC in an AD and MCI patient group. The clinical trial, titled "CopperProof 2" will test, for the first time, the effects of a novel gastro-retentive, sustained release zinc/cysteine combination tablet on the amelioration of sub-clinical zinc deficiency, and elevated percentage serum free copper, associated with Alzheimer's Disease. Adeona believes that Zinthionein™ ZC will prove to be beneficial to lowering high free copper levels and eliminating sub-clinical zinc deficiency in the AD and MCI populations. The company further believes correcting these free copper and zinc imbalances through dietary management may slow the progression of AD and MCI.

Max Lyon, Adeona's CEO, stated, "We are excited to introduce our first product offering for the very under-served Alzheimer's disease and cognitive impaired patient population. AD and MCI have been resistant to other therapeutic approaches, leaving many patients, and their caregivers, with little hope of stopping the continued progression of the patient's cognitive decline. We plan to identify those patients with copper and zinc imbalances and to provide therapeutic alternatives, such as high dose zinc therapy, which can correct these imbalances and may have a positive effect in slowing the progression of disease. We consider chronic copper toxicity and sub-clinical zinc deficiency to be a significantly under-recognized and modifiable risk factor for the progression of AD and MCI. Using our patent pending, modified oral zinc delivery technologies, we recently announced initiation of the first clinical trial of oral zinc therapy, Zinthionein™ ZC, for the once-a-day dietary management of AD and MCI."

About Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population. Adeona believes that these conditions may contribute to the progression of debilitating degenerative diseases, including, Dry Age-Related Macular Degeneration (Dry AMD), Alzheimer's disease (AD) and mild cognitive impairment (MCI) in susceptible persons. Using Adeona's proprietary, modified oral zinc delivery technologies, Adeona is preparing to initiate the first clinical trial of oral zinc therapy for the once-a-day dietary management of AD and MCI. Adeona is also developing a number of late-stage clinical drug candidates for the treatment of rheumatoid arthritis and multiple sclerosis. For further information, please visit www.adeonapharma.com.

About HartLab LLC

HartLab is a specialty clinical laboratory with the primary mission to be the leading national clinical laboratory for the testing of copper and zinc metabolic status in the mature population. Recent published scientific studies have shown the strong relationship between high inorganic ("free") copper levels in serum and the progression of Alzheimer's disease (AD) and mild cognitive impairment (MCI). A recent Adeona Pharmaceuticals sponsored study, presented at the 2009 International Congress on Alzheimer's Disease (ICAD), showed a sub-clinical zinc deficiency in Alzheimer's patients. HartLab has developed the CopperProof Test Panel which will provide a definitive analysis of copper and zinc metabolic status and identify those AD and MCI patients with high "free" copper levels and sub-clinical zinc deficiency, as well as provide other important diagnostic results. These individuals may be candidates for physician prescribed therapy to correct their copper and zinc imbalances. HartLab also serves the greater Chicago area with a full service clinical laboratory operation including a comprehensive menu of tests. Its website is www.hartlab.com.

For further background on the role of zinc and copper imbalance in Alzheimer's disease and mild cognitive impairment interested persons are directed to www.copperproof.com and the following references:

1. Sparks D. and Schreurs, B., Trace amounts of copper in water induce beta-amyloid plaques and learning deficits in a rabbit model of Alzheimer's disease. Proc. Natl. Acad. Sci. (2003) 100: 11065-11069.

2. Sparks DL, Friedland R, Petanceska S, Schreurs BG, Shi J, Perry G, Smith MA, Sharma A, Derosa S, Ziolkowski C, Stankovic G., Trace copper levels in the drinking water, but not zinc or aluminum influence CNS Alzheimer-like pathology, J Nutr Health Aging. (2006 Jul-Aug);10(4):247-54.

3. Deane R, Sagare A, Coma M, Parisi M, Gelein R, Singh I, Zlokovic B, A novel role for copper: Disruption of LRP-dependent brain A> clearance, Neuroscience 2007, Society for Neuroscience (Nov. 2007), Pres. 857.2

4. Kitazawa M, Cheng D, Laferla FM., Chronic copper exposure exacerbates both amyloid and tau pathology and selectively dysregulates cdk5 in a mouse model of AD., J Neurochem. (Mar. 2009);108(6):1550-60. Epub 2009 Jan 22.

5. Morris MC, Evans DA, Tangney CC, et al., Dietary copper and high saturated and trans fat intakes associated with cognitive decline., Arch Neurol. (2006) 63: 1085-1088.

6. http://www.ewg.org/tapwater/contaminants/contaminant.php>contamcode=1022

7. Committee on Copper in Drinking Water, Copper in Drinking Water, National Research Council, National Academy Press (2000).

8. Squitti R, Bressi F, Paswualetti P, Bonomini C, Ghidoni, R, Binetti G, Casetta E, Moffa F, Ventriglia M, Vernieri F, Rossini P., Longitudinal prognostic value of serum "free" copper in patients with Alzheimer's disease, Neurology, (Jan. 2009) 72: 50-55.

This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding designing additional clinical trials for its oral zinc therapies, dnaJP1, Zinthionein, Zinthionein ZC, flupirtine, or Trimesta. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Adeona's Hartlab subsidiary is generating modest revenues and its future success will likely depend upon its ability to successfully introduce and market new specialty diagnostic assays to generate additional revenues. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of Adeona's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's ability to promote or commercialize its products for awareness, prevention, diagnosis or treatment of zinc deficiency and chronic copper toxicity, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, that we will continue to meet the continued listing requirements of the American Stock Exchange (which, unlike other exchanges, does not require us to maintain any minimum bid price with respect our stock but does require us to maintain a minimum of $4 million in stockholders' equity during the current year, for example), our inability to obtain the capital necessary to fund the company's research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2008, Forms 10-Q for quarters ending in 2009 and any other filings with the SEC. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. Zinthionein™ ZC-GS150 is a patent pending modified release formulation containing 150mg of elemental zinc and other ingredients that does not contain zinc-monocysteine. Zinthionein™ and CopperProof™ are a trademarks of Adeona Pharmaceuticals, Inc. Diagnostic uses of the CopperProof trademark are exclusively licensed by Hartlab LLC. Certain elements of the CopperProof Test Panel are Laboratory Developed Tests and not approved by the FDA.

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