Pipex Pharmaceuticals Receives FDA Orphan Drug Designation for Oral TTM for Idiopathic Pulmonary Fibrosis (IPF)
May 12 2008 - 9:23AM
Marketwired
ANN ARBOR, MI , a specialty pharmaceutical company developing
innovative late-stage drug candidates for the treatment of
neurologic and autoimmune diseases, announced today that it has
received an Orphan Drug designation for oral tetrathiomolybdate
(oral TTM) from the FDA for the treatment of Idiopathic Pulmonary
Fibrosis (IPF), a deadly pulmonary disease with no FDA-approved
therapy.
IPF is a fatal respiratory disease characterized by progressive
loss of lung function due to extensive fibrosis of lung tissues
that are essential for respiration and life. According to the
Coalition for Pulmonary Fibrosis, IPF affects an estimated 128,000
patients in the U.S., including 48,000 new patients per year, and
results in approximately 30,000 deaths in the U.S. annually, more
than the number of U.S. deaths annually from either breast or
prostate cancer. Currently, there are no FDA-approved therapies for
IPF. The standard of care for IPF patients is high-dose
corticosteroids and immunosuppressants, which have numerous side
effects that increase patient morbidity.
Steve H. Kanzer, CPA, JD, Chairman and Chief Executive Officer
of Pipex stated, "Oral TTM has completed a 12 month open label
phase I/II clinical trial in refractory IPF patients the results of
which were reported at the May 2007 Annual Meeting of the American
Thoracic Society. Provided that we elect to file an IND for oral
TTM and pursue the further clinical development of oral TTM for
IPF, this orphan drug designation provides additional exclusivity
that supports our exclusively licensed issued U.S. Patent 6,855,340
and pending international patents covering the use of oral TTM for
IPF and other high value fibrotic indications. The highly
successful Orphan Drug Act of 1983 (as amended) would now provide
our potential pharmaceutical partners or acquirors with a 50% tax
credit for Phase III oral TTM IPF clinical trial expenses, for
example, thereby reducing the after-tax cost of any such additional
clinical trials to as little as 27%."
The United States Orphan Drug Act of 1983 was created to provide
incentives for companies to develop and market treatments for
diseases or conditions affecting fewer than 200,000 people in the
United States. The Orphan Drug designation provides eligibility for
a seven-year period of market exclusivity in the United States
after product approval, an accelerated review process, grant
funding, tax benefits, and an exemption from user fees.
About Oral TTM in Fibrotic Diseases
Oral 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. Pipex is developing oral TTM
for fibrotic disorders based upon the rationale that the fibrotic
disease process is dependent upon the availability of free copper
in the body. Oral 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), NFkB, TGF-B, FGF-2, IL-1, IL-6, IL-8, and connective
tissue growth factor (CTGF).
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty
pharmaceutical company that is developing four 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 to complete the
further clinical testing, manufacturing and regulatory requirements
sufficient to seek marketing authorizations via the filing of New
Drug Applications (NDAs). Pipex's drug candidates address the
following market opportunities, Multiple Sclerosis (MS), Dry
Age-Related Macular Degeneration (AMD), Fibromyalgia, Huntington's
Disease, Alzheimer's Disease, neurologic Wilson's disease and
Idiopathic Pulmonary Fibrosis. For further information please visit
www.pipexinc.com.
This release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding Pipex's plans for its
product candidates. Words such as, but not limited to, "look
forward to," "believe," "expect," "anticipate," "estimate,"
"intend," "plan," "targets," "likely," "will," "would," "should,"
and "could," and similar expressions or words identify
forward-looking statements. Such forward-looking statements are
based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Pipex is at an early
stage of development and may not ever have any products that
generate significant revenue. Important factors that could cause
actual results to differ materially from those reflected in Pipex's
forward-looking statements include, among others, a failure of
Pipex's product candidates to be demonstrably safe and effective, a
failure to obtain regulatory approval for the company's products or
to comply with ongoing regulatory requirements, a lack of
acceptance of Pipex's product candidates in the marketplace, a
failure of the company to become or remain profitable, Pipex's
inability to obtain the capital necessary to fund its research and
development activities, a loss of any of the company's key
scientists or management personnel, and other factors described in
Pipex's report on Form 10-K for the year ended December 31, 2007.
No forward-looking statements can be guaranteed and actual results
may differ materially from such statements. The information in this
release is provided only as of the date of this release, and Pipex
undertakes no obligation to update any forward-looking statements
contained in this release on account of new information, future
events, or otherwise, except as required by law.
For Further Information Contact: Steve H. Kanzer CPA, Esq.
Chairman and Chief Executive Officer (734) 332-7800 Thomas
Redington Investor Relations Redington, Inc. (203) 222-7399
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