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<SEC-DOCUMENT>0000890163-08-000117.txt : 20080229
<SEC-HEADER>0000890163-08-000117.hdr.sgml : 20080229
<ACCEPTANCE-DATETIME>20080229150808
ACCESSION NUMBER:		0000890163-08-000117
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20080229
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20080229
DATE AS OF CHANGE:		20080229

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			PIPEX 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:		08655035

	BUSINESS ADDRESS:	
		STREET 1:		3985 RESEARCH PARK DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108
		BUSINESS PHONE:		734-332-7800

	MAIL ADDRESS:	
		STREET 1:		3985 RESEARCH PARK DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108

	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>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>s11-8200_8k.htm
<DESCRIPTION>FORM 8-K
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<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><b><font SIZE=5>UNITED STATES</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font SIZE=5>SECURITIES AND EXCHANGE COMMISSION</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font SIZE=2>WASHINGTON, D.C. 20549</font></b></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><b><font SIZE=5>FORM 8-K</font></b></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><b><font SIZE=2>CURRENT REPORT</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font SIZE=2>PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934</font></b></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><font size=2>Date of Report (Date of earliest event reported): February 29, 2008</font></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><font size=2>Pipex Pharmaceuticals, Inc.</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=2>(Exact name of registrant as specified in its charter)</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


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    <tr style=' height:39.2pt'>
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            <p style='margin-left:3.0pt;text-indent:-3.0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>Delaware</font></p>
<p style='margin-left:3.0pt;text-indent:-3.0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>(State or other jurisdiction of</font></p>
<p style='margin-left:3.0pt;text-indent:-3.0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>incorporation)</font></p> </td>
        <td width="29%" valign=top style=' height:39.2pt'>
            <p style='margin-left:.75pt;text-indent:0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>01-12584</font></p>
<p style='margin-left:.75pt;text-indent:0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>(Commission</font></p>
<p style='margin-left:.75pt;text-indent:0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>File Number)</font></p> </td>
        <td width="41%" style='height:39.2pt'>
            <p style='margin-left:.75pt;text-indent:0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>13-3808303</font><br> <font size=2>(IRS Employer</font></p>
<p style='margin-left:.75pt;text-indent:0pt;text-align:center;margin-top:0in;margin-bottom:0in'><font size=2>Identification Number)</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=2>3930 Varsity Drive</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=2>Ann Arbor, MI 48108</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font size=2>(Address of principal executive offices) (Zip Code)</font></b></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:center;'><font size=2>(734) 332-7800</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font size=2>(Registrant's telephone number, including area code)</font></b></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:left;'><font size=2>Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:</font></p>

<p style=' margin-bottom:0pt; margin-top:11.25pt;text-align:left;'><font size=2>&nbsp;</font></p>


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        <td width="94%" valign=top style=' height:13.9pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p> </td> </tr>
    <tr style='height:13.15pt'>
        <td width="5%" valign=top style=' height:13.15pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>|_|</font></p> </td>
        <td width="94%" valign=top style=' height:13.15pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></p> </td> </tr>
    <tr style='height:27.8pt'>
        <td width="5%" valign=top style=' height:27.8pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>|_|</font></p> </td>
        <td width="94%" valign=top style=' height:27.8pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act </font><br> <font size=2>(17 CFR 240.14d-2(b))</font></p> </td> </tr>
    <tr style='height:27.05pt'>
        <td width="5%" valign=top style=' height:27.05pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>|_|</font></p> </td>
        <td width="94%" valign=top style=' height:27.05pt'>
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:6.0pt'><font size=2>Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act </font><br> <font size=2>(17 CFR 240.13e-4(c))</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>
<br>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:12pt; margin-top:0pt;text-align:left;'><b><font size=2>Item 8.01 Other Events.</font></b></p>

<p style=' margin-bottom:5pt; margin-top:5pt; text-indent:0.54in;text-align:justify;'><font size=2>On February 29, 2008, the Registrant issued a press release reporting that it has completed a Type A meeting with the FDA regarding its previously submitted New Drug Application (NDA) for oral tetrathiomolybdate (TTM, formerly COPREXA) for the treatment of initially presenting neurologic Wilson&#146;s disease.The press release is furnished as an exhibit to this current report. </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


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            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><b><font size=2>Item 9.01</font></b></p> </td>
        <td width="82%" valign=top >
            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><b><font size=2>Financial Statements and Exhibits</font></b></p>
<p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
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            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>(d)</font></p> </td>
        <td width="82%" valign=top >
            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Exhibits</font></p>
<p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
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            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><u><font size=2>Exhibit No.</font></u><u></u></p> </td>
        <td width="82%" valign=top >
            <p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><u><font size=2>Description</font></u></p>
<p style='margin-left:5.4pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
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            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:12.0pt'><font size=2>99.1</font></p> </td>
        <td width="82%" valign=top >
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:12.0pt'><font size=2>Press Release  </font></p> </td> </tr>
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            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:12.0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="82%" valign=top >
            <p style='margin-left:5.75pt;text-indent:0pt;text-align:left;margin-top:0in;margin-bottom:12.0pt'><font size=1>&nbsp;</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:12pt; margin-top:6pt;text-align:center;'><font SIZE=2>SIGNATURE</font></p>

<p style=' margin-bottom:12pt; margin-top:0pt; text-indent:0.5in;text-align:left;'><font size=2>Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font SIZE=2>PIPEX PHARMACEUTICALS, INC.</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Dated: February 29, 2008</font></p> </td>
        <td  colspan="2" valign=top >
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>By:  </font><u><font size=2>/s/ Steve H. Kanzer</font></u></p> </td>
        <td width="3%" valign=top >
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><u><font size=2>.</font></u></p> </td>
        <td  width="8%">
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td> </tr>
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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td>
        <td width="20%" valign=top >
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Steve H. Kanzer</font></p> </td>
        <td   colspan="3">
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td> </tr>
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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td>
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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Chairman and Chief Executive Officer</font></p> </td> </tr>
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        <td width="336" ></td>

        <td width="124" ></td>

        <td width="68" ></td>

        <td width="24" ></td>

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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


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<DESCRIPTION>EXHIBIT 99
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><img src="img1.jpg"><br> </p>

<p style=' margin-bottom:3pt; margin-top:12pt;text-align:center;'><b><font size=5>Pipex Pharmaceuticals Completes Type A Meeting with FDA for Oral Tetrathiomolybdate New Drug Application</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=3>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><b><font size=3>Company to Host Conference Call at 9:00 am Eastern Time Today </font></b></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Ann Arbor, Michigan, February 29, 2008 -- Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has completed a Type A meeting with the FDA regarding its previously submitted New Drug Application (NDA) for oral tetrathiomolybdate for the treatment of initially presenting neurologic Wilson&#146;s disease.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>A conference call has been scheduled for 9:00am ET today.  In order to participate in the conference call, please call toll free: 866-898-9626 (US); international dial-in: 416-340-2216.  A replay of the conference call will be archived for at least 30 days on Pipex&#146;s website at www.pipexinc.com.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>In response to a refusal to file (RTF) notice regarding Pipex&#146;s NDA submission received by Pipex from the FDA on January 28, 2008, Pipex requested and was granted a meeting with the FDA to discuss the issues raised in the RTF letter.  The outcome of the meeting with the FDA earlier this week, Pipex received resolution and guidance on the following RTF issues:</font></p>


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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td width="87%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Chemistry, manufacturing and controls (CMC):</font></p> </td> </tr></table>

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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td width="95%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>FDA agreed that with some revisions, Pipex&#146;s proposed analytical plan and methodology to characterize the active pharmaceutical ingredient for TTM should be sufficient for filing the NDA;</font></p> </td> </tr></table>

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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td width="86%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Preclinical Reproductive Toxicology Study:</font></p> </td> </tr></table>

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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td width="95%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>The FDA agreed to allow this preclinical reproductive toxicology study to be conducted as a post-approval commitment;  </font></p> </td> </tr></table>

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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td width="89%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Formatting and Presentation items contained in the NDA:</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

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<table border="0" cellspacing=0 cellpadding=0  style='margin-left:.5in;border-collapse:collapse'>
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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td>
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            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td  valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>The FDA agreed with Pipex&#146;s plan to rectify the formatting and presentation deficiencies contained within the NDA filing;</font></p> </td> </tr>
    <tr >
        <td width="4%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td  colspan="3" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Assessments concerning the adequacy and quality of the clinical evidence to support the safety and efficacy of TTM:</font></p> </td> </tr>
    <tr >
        <td   colspan="2">
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></td>
        <td width="4%" valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font></p> </td>
        <td  valign=top style='padding:5.0pt 0in 5.0pt 0in'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Pipex and the FDA agreed that these items would be considered review items by the FDA for a refiled NDA.</font></p> </td> </tr>
    <tr>
        <td width="31" ></td>

        <td width="31" ></td>

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        <td  ></td> </tr> </table>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>"We are grateful to the FDA for granting us a meeting so quickly, the considerable time and effort devoted by the reviewers evaluating the filing, as well as the very valuable feedback and guidance provided.  We are also encouraged by the FDA&#146;s willingness to continue our fruitful dialogue as a path forward to a new submission for this NDA for this important therapeutic modality to treat this debilitating disease for which patients have limited treatment options.  We look forward to working with the FDA to submit to them a considerably improved, comprehensive and high quality data package to facilitate their review.  Since the receipt of the RTF, Pipex has engaged several new additional regulatory advisors and experts in NDA submissions to aid in this refiling process as well as our planned MAA submission in Europe.&#148; said Steve H. Kanzer, CPA, JD, Pipex&#146;s Chairman &amp; Chief Executive Officer.&#148;</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Based on this meeting with the FDA, Pipex believes it reached an understanding with the FDA on a course of action to resolve all of the filing issues raised in the RTF letter. Nevertheless, the FDA raised concerns regarding the adequacy of the evidence of clinical efficacy, safety, study quality, data collection and overall risk/benefit profile of oral TTM for neurologic Wilson&#146;s disease as represented by the two completed clinical trials of TTM for neurologic Wilson&#146;s disease that formed the basis of the NDA.</font><sup><font size=2>(1),(2)</font></sup><font size=2>  Even if Pipex is successful in preparing and filing a revised NDA, Pipex cannot provide any assurances that a newly filed NDA will be accepted for filing or that upon review of the NDA by the FDA, Pipex will be successful in overcoming such FDA concerns and that oral TTM for initially presenting neurologic Wilson&#146;s disease will
be approved by the FDA.    </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>In order to enhance a resubmitted NDA filing for oral tetrathiomolybdate for the treatment of neurologic Wilson&#146;s disease, at the recent meeting Pipex discussed with the FDA Pipex&#146;s plans to schedule a Type B meeting with the FDA to discuss the utility of providing the FDA with additional efficacy data from an ongoing double-blind, comparator, dose optimization clinical trial of oral tetrathiomolybdate for the treatment of neurologic Wilson&#146;s disease.  To date, this third ongoing study has enrolled and completed dosing in 40 neurologically presenting Wilson&#146;s disease patients.  At the Type B meeting to be scheduled, Pipex intends to also present potential available pharmacokinetic (PK) data from this ongoing clinical trial as well as a summarization of the PK data from the previously completed clinical trials with TTM for neurologic Wilson&#146;s disease.  The feedback from this Type B
meeting with the FDA will determine the timing of any potential NDA resubmission for oral tetrathiomolybdate for this indication.  Additionally, depending on the analysis of additional PK data, the FDA may </font></p>

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<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>request a separate PK study.  Type B meetings are typically granted within sixty days (60) from a formal meeting request.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Last month, Pipex received written notification from a third party company objecting to Pipex&#146;s use of the &#147;COPREXA&#148; tradename for oral TTM on the grounds that such tradename was too similar to a tradename already in use by such company.  Accordingly, Pipex has agreed to abandon the &#147;COPREXA&#148; tradename and will select an agreeably dissimilar new tradename for oral TTM in the near future. </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>About Oral Tetrathiomolbydate </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Oral tetrathiomolybdate (TTM) is a small-molecule, anti-copper agent that is highly specific for the reduction of free copper in serum, the most toxic form of copper in the body, and is thus suited for the treatment of central nervous system (CNS) diseases in which abnormal serum and CNS copper homeostasis are implicated.  TTM has completed two clinical trials in initially presenting neurologic Wilson&#146;s disease patients, the results of which have been previously published</font><sup><font size=2>(1)(2)</font></sup><font size=2>.  Pipex is also developing TTM for fibrotic disorders based upon the rationale that the fibrotic disease process is dependent upon the availability of free copper in the body.  TTM has demonstrated the ability to inhibit fibrosis in a number of well established animal models through the sequestration of available copper and inhibition of key fibrotric cytokines, including
secreted protein acid rich in cysteine (SPARC), NF?B, TGF-&#223;, FGF-2, IL-1, IL-6, IL-8, and connective tissue growth factor (CTGF).  TTM has been designated as an &#147;Orphan Drug&#148; by the FDA for the treatment of initially presenting neurologic Wilson&#146;s Disease.</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>TTM has completed a 20-patient, one year, open label, phase I/II clinical trial for the treatment of refractory idiopathic pulmonary fibrosis (IPF), a fatal respiratory disease.  </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>About Wilson&#146;s Disease </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Wilson&#146;s disease is an autosomal recessive genetic disease attributable to mutations of the </font><i><font SIZE=2>ATP7B</font></i><font size=2> gene.  Worldwide, it is estimated that there are between 10 million and 30 million carriers of the heterozygous mutated gene.  These mutations lead to an inability to properly clear excess free copper from the body via the liver into the bile and stool.  As a result, copper accumulates in the liver and elevated levels of toxic free copper enter the systemic circulation, cross the blood brain barrier, and enter the cerebral spinal fluid (CSF) and brain.  These increased levels of free copper cause significant neurologic damage, resulting in tremors, impaired speech, impaired coordination, and Parkinson&#146;s-like dystonia.  </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Psychiatric symptoms of neurologically-presenting Wilson&#146;s patients will generally precede neurologic symptoms by months or years and may include loss of emotional control, temper tantrums, emotional outbursts, bouts of crying, severe depression, suicidal ideation, loss of inhibitions, delusions, hallucinations and loss of ability to focus on tasks. Neurologic symptoms later develop as a result of neurodegeneration in the basal ganglia of the brain and include impaired speech, tremor, dystonia, incoordination and </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>dysphasia. Crippling movement disorders may ultimately occur. Without proper treatment, Wilson&#146;s disease is usually fatal by the age of 30.  However, if treatment is begun early enough, symptomatic recovery is usually complete and a life of normal length and quality can be expected.  For more information about Wilson&#146;s disease, please visit or contact the Wilson&#146;s Disease Association at www.wilsonsdisease.org.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:left;'><b><font size=2>About Pipex Pharmaceuticals, Inc. </font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Pipex Pharmaceuticals, Inc. (&#147;Pipex&#148;) is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases.  Pipex&#146;s strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA).  For further information please visit www.pipexinc.com.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt; text-indent:0.5in;text-align:justify;'><font size=2>(1) &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Brewer, G.J., et al., Treatment of Wilson&#146;s disease with ammonium tetrathiomolybdate: III. Initial therapy in a total of 55 neurologically affected patients and follow-up with zinc therapy.  </font><i><font size=2>Arch Neurol</font></i><font size=2>. 2003 Mar; 60(3):379-85.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt; text-indent:0.5in;text-align:justify;'><font size=2>(2)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Brewer, G.J., Askari, F., Lorincz, M.T., Carlson, M., Schilsky, M., Kluin, K.J., Hedera, P., Moretti, P., Fink, J.K., Tankanow, R., et al. 2006. Treatment of Wilson&#146;s disease with ammonium tetrathiomolybdate: IV. Comparison of tetrathiomolybdate and trientine in a double-blind study of treatment of the neurologic presentation of Wilson disease. </font><i><font size=2>Arch Neurol</font></i><font size=2> 63:521-527.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and subsidiaries (&#147;we&#148; or &#147;our&#148;) current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of oral tetrathiomolybdate (formerly COPREXA) as well as the resolution of any of the deficiencies raised by the FDA noted in this announcement, including any additional safety and efficacy concerns that the FDA has raised, including the potential delay in potential filing or approval as well as the cost and expense of conducting any additional testing, development and/or clinical trials required by the FDA, the prospects for any regulatory filings in the treatment of neurologic Wilson&#146;s disease, including and/or that the FDA will agree with our
analysis of data supporting the safety, clinical efficacy, manufacturing, stability and other regulatory requirements necessary for TTM to be approved for use in neurologically presenting Wilson&#146;s disease or that even if approved for initial indication, that we will be able to conduct and complete necessary initial and registration clinical trials required to support and receive FDA approval for a Supplemental New Drug Application to market TTM for the treatment of other disease indications, such as, idiopathic pulmonary fibrosis, Alzheimer&#146;s disease and Huntington&#146;s disease, for example.  Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other </font></p>

<p style=' margin-bottom:0pt; margin-top:5pt;text-align:justify;'><font size=2>&nbsp;</font></p>
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<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, including risks set forth in our filings with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including oral TTM, TRIMESTA&#153;, zinc monocysteine, SOLOVAX&#153;, EFFIRMA&#153; or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced
or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise, other than as required by law. </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>For Further Information Contact:</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Steve H. Kanzer, CPA, JD</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Chairman and Chief Executive Officer</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>(734) 332-7800</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Thomas Redington (Investor Relations)</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Redington, Inc.</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>(203) 222-7399</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'>&nbsp;</p>



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