Pipex Pharmaceuticals Announces Fourth Quarter and Year End 2007 Results

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Mon Mar 31, 2008 4:42pm EDT

  ANN ARBOR, MI, Mar 31 (MARKET WIRE) -- 
 Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company
developing innovative late-stage drug candidates for the treatment of
neurologic and fibrotic diseases, today announced its results for the fourth
quarter and year end 2007.

    A conference call has been scheduled for 5:00pm 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 10 days on Pipex's website at www.pipexinc.com.

    Achievements and accomplishments for the year end 2007 included:


--  Initiated a multicenter 150 patient Phase II/III clinical trial for
    TRIMESTA, our oral once-daily estriol therapy for the treatment of multiple
    sclerosis, under a $5 million grant from the Southern California Chapter of
    the National Multiple Sclerosis Society with participation from the NIH
--  Filed Investigational New Drug Application (IND) for Oral Flupirtine
    to initiate a phase II clinical trial in fibromyalgia
--  Began trading on the American Stock Exchange (AMEX) as "PP"
--  Expanded TRIMESTA related intellectual property broadly through an
    issued European patent
--  Broadened our license agreement with Oregon Health & Sciences
    University relating to estrogen therapy to treatment autoimmune diseases
--  Acquired a phase II oral drug candidate for dry age related macular
    degeneration (AMD) which had completed an 80 patient double blind phase II
    clinical trial in dry age-related macular degeneration (AMD) demonstrating
    a statistically significant improvement in visual acuity, contrast
    sensitivity, and photorecovery times
--  Demonstrated a 40% reduction in insoluble amyloid-beta using oral TTM
    in a transgenic animal model of Alzheimer's disease
--  Initiated testing of oral TTM in a transgenic animal model of
    Huntington's Disease through a Cooperative Research and Development
    Agreement (CRADA)
--  Presented results from a one year open label phase I/II clinical trial
    of oral TTM for refractory idiopathic pulmonary fibrosis (IPF) at the
    American Thorasic Society (ATS)
--  Appointed Daniel J. Dorman and Dr. James S. Kuo to the Board of
    Directors
--  Completed acquisition of the minority interest in our subsidiary,
    Effective Pharmaceuticals, Inc. (EPI)
--  Completed construction and qualification of a cGMP manufacturing
    facility in Ann Arbor, Michigan
    

    
Steve H. Kanzer,CPA, JD, Chairman and Chief Executive Officer,
commented on the financial results, "Despite our setback with our oral TTM
NDA filing for neurologic Wilson's disease, we would like to communicate the
depth and progress made with respect to our pipeline of additional clinical
stageproduct candidates, in particular TRIMESTA, our once-daily oral therapy
formultiple sclerosis which is in a phase II/III clinical trial as well as oral
flupirtine, our drug candidate for the treatment of fibromyalgia."

    Financial Results for Fourth Quarter and Year End 2007:

    At December 31, 2007, Pipex had cash of approximately $11.5 million,
compared to
approximately $12.2 million at December 31, 2006. The decrease of approximately
$700,000 is attributable primarily to net cash used in operations of
approximately $6.6 million and net cash used to purchase property and equipment
of
approximately $2.0 million offset by the net proceeds from the sale of common
stock relating to the exercise of warrants of approximately $7.0 million and the
proceeds from a note payable, less payments on principal, of $900,000.

    The net loss applicable to common shareholders for the quarter ended
December
31, 2007 was $3,159,553, or $0.23 per share, compared to a net loss
applicable to common shareholders of $2,680,557, or $0.09 per share, for the
comparable quarter in 2006, representing an increase in net loss of
$478,996. The increase in net loss was primarily attributable to an increase
in research and development expenses totaling $870,111 that primarily related
to Pipex's oral TTM(TM) NDA directed activities, including establishing a GMP
manufacturing facility in Ann Arbor, MI and hiring the necessary clinical,
regulatory and manufacturing personnel, as well as activities associated
with development of Pipex's other product candidates, TRIMESTA(TM), anti-CD4
802-2, CORRECTA(TM), SOLOVAX, Z-monocys and EFFIRMA(TM). The increase was offset
by
a charge in the fourth quarter of 2006, totaling $570,750 for a preferred stock
dividend for one of our subsidiaries. This charge was reflected through equal
and offsetting adjustments to additional paid-in-capital with no net impact on
stockholders' equity.

    The net loss applicable to common shareholders for the year ended December
31,
2007 was $22,302,155, or $1.27 per share, compared to the net loss applicable
to common shareholders of $4,860,095, or $1.50 per share, for the year ended
December 31, 2006, representing an increase of $17,442,060. The increase in net
loss
was primarily attributable to a non-cash charge of $12,409,722 related to
the acquisition of Effective Pharmaceuticals, Inc. ("EPI") in the first
quarter of 2007. This charge was reflected through equal and offsetting
adjustments to additional paid-in-capital with no net impact on stockholders'
equity. Also attributing to the increase in net loss is an increase in
research and development expenses of $3,662,171 that primarily related to
Pipex's oral TTM(TM) NDA directed activities, including establishing a GMP
manufacturing facility in Ann Arbor, MI and hiring the necessary clinical,
regulatory and manufacturing personnel, as well as activities associated
with development of Pipex's other product candidates, TRIMESTA(TM), anti-CD4
802-2, CORRECTA(TM), SOLOVAX, Z-monocys and EFFIRMA(TM). Research and
development
expense for the year ended December 31, 2007 also includes a non-cash
stock-based compensation charge of $1,372,470. The increase in net loss was also
due to a $2,359,063 increase in general and administrative expense which
includes a
non-cashstock-based compensation charge of $1,385,636.

    Oral TTM for Neurologic Wilson's disease Indication

    Based upon receipt of written clinical hold letter communicated to a
collaborator's IND from the FDA, the FDA communicated concerns previously
disclosed
regarding the adequacy of the evidence of clinical efficacy, safety, study
quality,
data collection and overall risk/benefit profile of oral TTM for the
treatment of neurologic Wilson's disease as represented by the two completed
clinical trials of TTM for neurologic Wilson's disease that formed the basis of
the previous NDA submission.  In the written hold letter to the IND, the FDA
raised additional chemistry, manufacturing and controls questions, as well as
provided feedback regarding the lack of sufficiency of the 40 patient
comparator clinical study as to the previous two clinical studies.  While we
remain hopeful for the ultimate approvability and utility of oral TTM for
neurologic Wilson's disease as well as additional therapeutic indications,
based upon our review of the recent written clinical hold letter from by the
FDA made available to us last week, at the present time, it appears that the
FDA will not deem the three existing clinical trials of oral TTM to be
sufficient for an NDA for the treatment of neurologic Wilson's disease.

    About Pipex Pharmaceuticals, Inc.

    Pipex Pharmaceuticals, Inc. is a specialty pharmaceutical company that is
developing proprietary, late-stage drug candidates for the treatment of
neurologic and fibrotic diseases.  Pipex's strategy is to exclusively in-license
proprietary, clinical-stage drug candidates and complete the further clinical
testing, manufacturing and regulatory requirements and seek marketing
authorizations.  Pipex is focused on treating multiple sclerosis, fibromyalgia,
Alzheimer's disease, Huntington's disease, neurologic Wilson's disease, Dry Age
Related Macular Degeneration (AMD). For further information, please visit,
www.pipexpharma.com.

    (1)  Brewer, G.J., et al., Treatment of Wilson's disease with ammonium
tetrathiomolybdate: III. Initial therapy in a total of 55 neurologically
affected
patients and follow-up with zinc therapy.  Arch Neurol. 2003 Mar; 60(3):379-85.

    (2)  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'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. Arch Neurol
63:521-527.

    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 ("we," "our" or "Company") current
expectations about its future results, performance, prospects and
opportunities, including statements regarding the potential uses of oral TTM
for various uses including the treatment of Alzheimer's disease, inflammatory
and
fibrotic diseases, as well as its the prospects for regulatory filings in the
treatment of neurologic Wilson's disease.  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. We cannot assure you that we will be
able to successfully develop or commercialize products based on our
technologies,including oral TTM, TRIMESTA, SOLOVAX, EFFIRMA, zincmonocysteine 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. 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, including risks detailed in the Company's SEC
reports, including the Company's Form 10-KSB. Copies of the filings are
available at www.sec.gov.

    

For Further Information Contact:

Steve H. Kanzer, CPA, Esq.
Chairman and Chief Executive Officer
(734) 332-7800

Charles Bisgaier, Ph.D.
President
(734) 332-7800

Redington, Inc. (Investor Relations)
Thomas Redington
203-222-7399
www.redingtoninc.com

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