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<SEC-DOCUMENT>0000890163-08-000032.txt : 20080129
<SEC-HEADER>0000890163-08-000032.hdr.sgml : 20080129
<ACCEPTANCE-DATETIME>20080129135156
ACCESSION NUMBER:		0000890163-08-000032
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20080129
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20080129
DATE AS OF CHANGE:		20080129

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:		08557177

	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>s11-8113_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): January 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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            <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:12pt; margin-top:0pt; text-indent:0.54in;text-align:left;'><font size=2>On January 29, 2008, the Registrant issued a press release reporting that it had received notice from the FDA that the Registrant&#146;s previously filed New Drug Application (NDA) for oral tetrathiomolybdate (COPREXA) has several areas of deficiencies, and that the FDA has therefore not accepted the NDA filing for further review as submitted.  The press release is furnished as an exhibit to this current report. </font></p>

<p style=' margin-bottom:12pt; margin-top:0pt;text-align:left;'><font size=1>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&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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        <td width="17%" 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>
        <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: January 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>
        <td  colspan="4" valign=top >
            <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>

<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>


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<DESCRIPTION>EXHIBIT 99.1
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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 Provides Update on COPREXA (Oral Tetrathiomolybdate) New Drug Application</font></b></p>

<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;'><b><font size=3>Company to Host Conference Call at 8:30 am Eastern Time Today </font></b></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Ann Arbor, Michigan, January 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 received notice from the FDA that its New Drug Application (NDA) for oral tetrathiomolybdate (COPREXA) for the treatment of initially presenting neurologic Wilson&#146;s disease has not been accepted by the FDA for further review as submitted.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>A conference call has been scheduled for 8:30am ET today.  In order to participate in the conference call, please call toll free:</font><b><font size=2> </font></b><font size=2>866-300-7687 (US); international dial-in: 416-641-6142.  The call will be archived and available for replay for at least 30 days by accessing the company&#146;s website at </font><u><font size=2>www.pipexinc.com</font></u><font size=2>. </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Pipex believes that the clinical and nonclinical deficiencies cited by the FDA were already discussed, resolved and agreed upon with the FDA during one of the two pre-NDA meetings held with a first review division of the FDA in August of last year.  Pipex relied upon and believes it honored those commitments in the NDA it filed.  Pipex was notified by the FDA that the NDA was transferred from the initial review division in which the pre-NDA meetings took place, to a new review division in late December.  According to the FDA, the FDA had determined that a medical group in the new review division had expertise in diseases resulting from inborn metabolic errors and would be a more appropriate group for the review of this application.  Pipex believes that this recent transfer may have resulted in a loss of continuity of discussion and detailed understanding and may have contributed to the FDA&#146;s decision
deny further review of the application as filed.  </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>The FDA communicated a refusal to file (&#147;RTF&#148;) under the sixty (60) day statutory period of 21 C.F.R. 314.101.  It is Pipex&#146;s position that the main issues cited by the FDA are substantive review items and therefore should be considered upon review of the application, as opposed to in the context of an RTF.  In response to this RTF, Pipex immediately requested a meeting with the FDA to discuss the perceived deficiencies in further detail with the expectation of either reaching agreement to file the NDA as submitted or reach agreement on what modifications are necessary in order for the </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>application to be filed.  The FDA, in accordance with regulations, has agreed to schedule this meeting within 30 days.  After this meeting with the FDA, Pipex plans to provide further details.</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>The eight RTF issues cited by the FDA include:</font></p>


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            <p><font size=2>-</font></p> </td>
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            <p><font size=2>the adequacy of the analytical methodology to characterize the active pharmaceutical ingredient of COPREXA;</font></p> </td> </tr>
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            <p><font size=2>-</font></p> </td>
        <td width="96%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p><font size=2>a request to conduct an additional short term reproductive drug safety study in animals;</font></p> </td> </tr>
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        <td width="3%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p><font size=2>-</font></p> </td>
        <td width="96%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p><font size=2>4 formatting and presentation items contained in the NDA; and</font></p> </td> </tr>
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        <td width="3%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p><font size=2>-</font></p> </td>
        <td width="96%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p><font size=2>2 preliminary assessments concerning the adequacy of the clinical evidence of safety and efficacy of COPREXA considered by Pipex to have been agreed upon with the FDA during two pre-NDA meetings.</font></p> </td> </tr></table>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Dr. Kenneth King, the lead regulatory consultant to Pipex involved in the preparation of the COPREXA NDA commented, &#147;The FDA is bound by their previous decisions, regardless of who made them, unless new evidence suggests the previous decisions or recommendations should be altered.  We worked hard with the FDA to facilitate the transfer of the agreements made in our pre-NDA meetings.  I believe the issues raised by the RTF decision are in large part the issues Pipex had discussed and reached agreement with the FDA.  We will, of course, work with the FDA to resolve any misunderstandings and reach agreement on the best way forward to initiate the review of this application and these comments received will assist us in re-submitting the application and securing the requisite approvals.&#148;  </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>Dr. Charles L. Bisgaier, Pipex&#146;s President commented, &#147;During our pre-NDA meetings with the prior interacting division, we believed we adequately addressed the substance and content of the planned NDA.  Our regulatory submission was based on these agreements.&#148;</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>"We are obviously disappointed with the FDA&#146;s decision not to accept the COPREXA NDA filing for further review at this time.  My hope is that upon further consideration within the next thirty 30 days the Agency, whose Orphan Products Division generously funded the 20 years of clinical testing of this important new treatment option for this desperate group of Wilson&#146;s disease patients, will be satisfactorily convinced that our New Drug Application should be accepted for filing and approved,&#148; said Steve H. Kanzer, CPA, Esq., Pipex&#146;s Chairman &amp; Chief Executive Officer.  </font></p>

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

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>COPREXA is an oral, 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.  COPREXA has completed two clinical trials in initially presenting neurologic Wilson&#146;s disease patients, the results of </font></p>

<p style=' margin-bottom:0pt; margin-top:5pt;text-align:justify;'><font size=2>&nbsp;</font></p>
<br>
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<pAGE>

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

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>which have been previously published</font><sup><font size=2>(1)(2)</font></sup><font size=2>.  Pipex is also developing COPREXA for fibrotic disorders based upon the rationale that the fibrotic disease process is dependent upon the availability of free copper in the body.  COPREXA 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).  COPREXA 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>COPREXA 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.  The results of this trial were presented in May of this year at the annual meeting of the American Thoracic Society (ATS).      </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 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 </font><u><font size=2>www.wilsonsdisease.org</font></u><font size=2>.</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 </font></p>

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

<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:justify;'><font size=2>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 </font><u><font size=2>www.pipexinc.com</font></u><font size=2>.</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 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 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 COPREXA as well as the resolution of any of the deficiencies raised by the FDA noted in this announcement, including the potential delay in potential 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 COPREXA 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 COPREXA 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 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 COPREXA&#153;, TRIMESTA&#153;, zincmonocysteine, 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 </font></p>

<p style=' margin-bottom:0pt; margin-top:5pt;text-align:justify;'><font size=2>&nbsp;</font></p>
<br>
<HR noshade align="center" width="100%" size="2">
<p style='page-break-before:always'></p>
<pAGE>

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

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>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, Esq.</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:justify;'><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>

<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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