ANN ARBOR, MI , 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 stage product candidates, in
particular TRIMESTA, our once-daily oral therapy for multiple
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-cash
stock-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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