<SEC-DOCUMENT>0001144204-11-023181.txt : 20110420
<SEC-HEADER>0001144204-11-023181.hdr.sgml : 20110420
<ACCEPTANCE-DATETIME>20110420134158
ACCESSION NUMBER:		0001144204-11-023181
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110419
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110420
DATE AS OF CHANGE:		20110420

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ADEONA PHARMACEUTICALS, INC.
		CENTRAL INDEX KEY:			0000894158
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133808303
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12584
		FILM NUMBER:		11770231

	BUSINESS ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108
		BUSINESS PHONE:		734-332-7800

	MAIL ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PIPEX PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20061214

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19970730

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD MEDICAL TECHNOLOGIES INC
		DATE OF NAME CHANGE:	19940606
</SEC-HEADER>
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<TYPE>8-K
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">CURRENT REPORT</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 36pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Item 8.01 &#8211; Other Events.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">On April 20, 2011, Adeona Pharmaceuticals, Inc., a Nevada corporation (the &#8220;Registrant") issued the attached press release regarding its agreement with TG United, Inc. for the manufacture and supply of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font>.&#160;&#160;A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K. The information contained in the press release is being furnished to the Commission and shall not be deemed incorporated by reference into any of the Registrant&#8217;s registration statements or other filings with the Commission.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Item 9.01</font> <font style="DISPLAY: inline; FONT-WEIGHT: bold">Financial Statements and Exhibits.</font></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Exhibit 99.1 Press Release issued by Adeona Pharmaceuticals, Inc. dated April 20, 2011.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">SIGNATURES</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#160;</div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona Executes Manufacturing and Supply Agreement with TG United for <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">&#8212; Contract Provides Commercial-Scale Manufacturing Capabilities of Company&#8217;s Zinc-Based Product<br>
Candidate for the Dietary Management of Alzheimer&#8217;s Disease and Mild Cognitive Impairment &#8212;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">For Immediate Release</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Ann Arbor, MI, April 20, 2011 &#8211;</font> Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN - News), a developer of innovative medicines for serious central nervous system diseases, announced today that it has executed an agreement with TG United, Inc. of Brooksville, Florida, to provide commercial-scale manufacturing capabilities for <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>. Adeona is developing <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, its product candidate for the dietary management of Alzheimer's disease and mild cognitive impairment, as a prescription medical food.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Top-line results from Adeona&#8217;s clinical study evaluating <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> for the dietary management of Alzheimer&#8217;s disease and mild cognitive impairment were presented last week at the 63<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">rd</font> Annual Meeting of the American Academy of Neurology. In the patients administered <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin, </font>the primary outcome of increasing serum zinc and decreasing serum free copper was effectively demonstrated. In addition, the average cognitive function of the placebo group declined over 6 months in comparison to patients managed with <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>. The cognitive function trends favoring the patients administered <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> were observed in all three standardized cognitive tests and suggest that <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> may provide an important dietary benefit to Alzheimer&#8217;s disease patients.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;Executing this agreement for the manufacturing of our product candidate, <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, is an important step for commercialization,&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer. &#8220;With the recent news that revised guidelines for diagnosing Alzheimer&#8217;s disease could double the population size, we are excited that <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> may be of benefit to this growing population, particularly in the earlier stages.&#8221;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About Medical Foods</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">A medical food<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">1</font> is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In general, to be considered a medical food, a product must, at a minimum, meet the following criteria (according to the Food &amp; Drug Administration (FDA) and the U.S. Congress, as part of the Orphan Drug Act):</font></div>

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<div align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona is developing <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, its product candidate for the dietary management of Alzheimer's disease and mild cognitive impairment, as a prescription medical food.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Reference:</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">1</font> Guidance for Industry: Frequently Asked Questions About Medical Foods. U.S. Food &amp; Drug Administration website. <font style="DISPLAY: inline; TEXT-DECORATION: underline">http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/ucm054048.htm</font>. May 1997; Revised May 2007; Accessed April 2011.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high oral bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) the ability to minimize gastrointestinal side effects of oral zinc therapy.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About Adeona Pharmaceuticals, Inc.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. The Company&#8217;s strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Currently, Adeona is developing, or has partnered the development of, the following product candidates: a prescription medical food for Alzheimer&#8217;s disease, and drugs for multiple sclerosis, fibromyalgia and age-related macular degeneration. For more information, please visit Adeona&#8217;s website at <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.adeonapharma.com</font>.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">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," "could," "potential," &#8220;positions,&#8221; "continue," "expects," "anticipates," "intends," "plans," "believe," "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 the use of zinc as a potential dietary management for cognitive deficits in Alzheimer&#8217;s patients, the size of the Alzheimer&#8217;s population&#160;&#160;and our intent to further commercialize development of reaZin as a prescription&#160;&#160;medical food. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, our failure to successfully commercialize reaZin for the management of Alzheimer&#8217;s disease, the failure of reaZin to be accepted for dietary management of Alzheimer&#8217;s disease,&#160;&#160;failure of future clinical trials studying&#160;&#160;reaZin to have favorable results, and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. 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.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">For further information, please contact:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">James S. Kuo, M.D., M.B.A.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Chief Executive Officer</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(734) 332-7800</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
