MARKET WIRE
Existing Promising Multi-Year Clinical Experience of Oral Flupirtine in Over 100 Patients With Diabetic Retinopathy, Maculopathy, Retinitis Pigmentosa and Glaucoma
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 that it has entered into an option to acquire an exclusive
worldwide license to issued and pending patent applications related to
additional uses of oral flupirtine for the treatment of a range of
ophthalmic, diabetes and diabetes-related therapeutic indications.
Pipex already has an existing exclusive license to the use of flupirtine
(Effirma) for the treatment of fibromyalgia, a rheumatic pain disease from
the McLean Hospital, a Harvard-affiliated hospital, and is currently
developing it for that indication in a double-blind phase II program under
a recently approved IND.
The potential therapeutic indications covered by the additional
intellectual property estate include glaucoma, age-related macular
degeneration (AMD), retinitis pigmentosa (RP), diabetic maculopathy, and
diabetic retinopathy and are supported by promising existing human clinical
data generated in European countries where flupirtine has been commercially
available for over 20 years and used by an estimated 1.5 million patients.
The intellectual property is supported by promising multi-year clinical
experience of oral flupirtine in over 100 patients with diabetic
retinopathy, maculopathy, retinitis pigmentosa and glaucoma.
Steve H. Kanzer, CPA, JD, Pipex's Chairman and Chief Executive Officer,
stated, "We are pleased to enter into this agreement to license this
intellectual property to enhance our patent estate for flupirtine and
complement our ophthalmic franchise which includes oral zinc-monocysteine
which has already completed an 80-patient, six month, double-masked,
placebo-controlled phase II clinical trial for dry age-related macular
degeneration (AMD), the publication of our positive results of which are
expected shortly."
Oral flupirtine, a non-opiate analgesic, has been approved in Europe since
1984 as a treatment for pain and has been tested in 2,775 patients in both
short- and long-term controlled clinical trials. Flupirtine has been used
by approximately 1.5 million European patients for more than 25 years for
treatment of post-surgical pain, cancer pain, trauma pain, pain associated
with liver disease, and other nocioceptive pain states; however, flupirtine
has never been approved for any indication in the United States.
Preclinical data and clinical experience suggests that flupirtine should be
effective for neuropathic pain since it acts in the central nervous system.
Flupirtine is especially attractive for this indication because it operates
through non-opiate pain pathways, exhibits no known abuse potential, and
lacks withdrawal effects. In addition, no tolerance to its
antinocioceptive effects has been observed.
Flupirtine's use in treating various ophthalmic disorders is supported by
promising clinical evidence generated by the clinical investigator and
inventor of the intellectual property that is the subject of the option
agreement. Pursuant to the terms of the agreement, Pipex has the option to
exclusively license pending application PCT/EP04/06738 and corresponding
U.S. patent application Ser. No. 11/316,570 as well as patents issued and
pending in additional countries.
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, Alzheimer's disease and
Idiopathic Pulmonary Fibrosis (IPF). 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 and its
option to acquire a license to issued and pending patent applications
related to uses of flupirtine. 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 to
acquire the license to issued and pending patent applications related to
uses of flupirtine, 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-Q for the year ended March 31, 2008. 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