Palatin Technologies, Inc. Announces Positive Safety Results in Subcutaneous Bremelanotide Trial in Men
FDA Meeting Expected in Q4 2010
CRANBURY, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Palatin
Technologies, Inc. (NYSE Amex: PTN) today announced positive
results of a Phase 1 clinical trial of subcutaneously administered
bremelanotide, its melanocortin agonist drug candidate for
treatment of male erectile dysfunction (ED) and female sexual
dysfunction (FSD). The results demonstrate that with subcutaneous
administration consistent therapeutic blood plasma levels can be
obtained without sustained clinically significant blood pressure
effects and support the continued development of
bremelanotide.
As part of the analysis of the effects of bremelanotide on blood
pressure, the Company engaged an independent panel of
cardiovascular experts to evaluate both study results and an
integrated cardiovascular safety analysis conducted on data from
completed bremelanotide studies. Based on recommendations from the
outside panel and its own internal review, Palatin intends to
engage the Food and Drug Administration (FDA) in discussions
regarding clinical trial designs to further study bremelanotide for
the treatment of sexual dysfunction.
Palatin expects to meet with the FDA in the fourth quarter of
calendar year 2010 to discuss initiation of a Phase 2 study of
subcutaneously administered bremelanotide, as a monotherapy and as
a combination therapy with a PDE-5 inhibitor such as sildenafil
(Viagra®), for men with ED who are not responsive or
inadequately responsive to PDE-5 inhibitor therapies alone.
The objective of the placebo-controlled, randomized,
double-blind, cross over safety study was evaluation of blood
pressure effects of subcutaneous bremelanotide in healthy male
volunteers between 45 and 65 years old. The study also evaluated
dose-to-dose consistency of plasma exposure of bremelanotide. A
total of 49 subjects were dosed in the safety study; nineteen of
the subjects were enrolled in a sub-study and completed a graded
exercise treadmill test as a surrogate for the cardiovascular
effects of sexual activity.
"The commercial opportunity of bremelanotide for sexual
dysfunction is significant. About 35% of patients with ED do not
respond to approved oral therapies, and with limited treatment
options these patients are ideal candidates for subcutaneous
bremelanotide," stated Carl Spana, Ph.D., President and CEO of
Palatin. "Plus, we have an additional opportunity with female
sexual dysfunction (FSD), which also represents a large market
opportunity with no FDA approved drugs."
About Erectile Dysfunction (ED)
Erectile dysfunction is the consistent inability to attain and
maintain an erection sufficient for sexual intercourse. Up to 35%
of men are non-responsive to standard therapies with
phosphodiesterase-5 inhibitors such as sildenafil (Viagra®),
vardenafil (Levitra®) and tadalafil (Cialis®). The current
worldwide market for ED drugs is over $4.0 billion. There are
limited therapeutic options for ED patients non-responsive to
phosphodiesterase-5 inhibitor therapy, including alprostadil for
direct penis injection or urethral suppositories, surgical penile
implants and various devices.
About Female Sexual Dysfunction (FSD)
FSD includes four disorders, hypoactive sexual desire disorder,
female sexual arousal disorder, sexual pain disorder and orgasmic
disorder. To establish a diagnosis of FSD, these syndromes must be
associated with personal distress, as determined by the affected
woman. A February 10, 1999 study published in the Journal of the
American Medical Association, titled, "Sexual Dysfunction in the
United States: Prevalence and Predictors," states that
approximately 43% of women suffer from some form of FSD. There are
no drugs in the United States approved for FSD indications.
About Bremelanotide
Bremelanotide, a synthetic peptide developed and solely owned by
Palatin Technologies, is believed to act through activation of
melanocortin receptors in the central nervous system. Nasal
formulations of bremelanotide have been extensively studied,
including Phase 2B studies for erectile dysfunction in both
non-diabetic and diabetic patients and Phase 2A studies for female
sexual dysfunction in both pre- and post-menopausal women.
Increases in blood pressure observed in some patients receiving
nasally administered bremelanotide, coupled with significant
variation in plasma levels, lead to discontinuation of nasally
administered bremelanotide as a first-line therapy for sexual
dysfunction. Palatin is developing subcutaneous bremelanotide as a
therapeutic for treatment of men with erectile dysfunction who are
non-responsive to standard therapies with phosphodiesterase-5
inhibitors such as sildenafil and for treatment of women with
female sexual dysfunction.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company
dedicated to the development of peptide, peptide mimetic and small
molecule agonists with a focus on melanocortin and natriuretic
peptide receptor systems. Palatin's strategy is to develop products
and then form marketing collaborations with industry leaders in
order to maximize their commercial potential. For additional
information regarding Palatin, please visit Palatin Technologies'
website at www.palatin.com.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin
Technologies, Inc. such as statements about bremelanotide clinical
trial results, potential actions by regulatory agencies including
the U.S. Food and Drug Administration (FDA), proposed indications
for bremelanotide, timing, duration, cost and results of proposed
clinical trials with bremelanotide, regulatory plans with
bremelanotide, and market potential for bremelanotide, are
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. Palatin intends that such
forward-looking statements be subject to the safe harbors created
thereby. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that could cause Palatin's
actual results to be materially different from its historical
results or from any results expressed or implied by such
forward-looking statements. Palatin's actual results may differ
materially from those discussed in the forward-looking statements
for reasons including, but not limited to, results of clinical
trials, regulatory actions by the FDA and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully complete clinical trials, the length
of time and cost required to complete clinical trials and submit
applications for regulatory approvals, products developed by
competing pharmaceutical, biopharmaceutical and biotechnology
companies, commercial acceptance of Palatin's products, and other
factors discussed in Palatin's periodic filings with the Securities
and Exchange Commission. Palatin is not responsible for updating
for events that occur after the date of this press release.
Source: Palatin Technologies, Inc.
CONTACT: Carney Noensie, Burns McClellan, Vice President,
Investor
Relations, +1-212-213-0006, cnoensie@burnsmc.com,
Stephen T. Wills, CPA, MST,
EVP-Operations/Chief Financial Officer, +1-609- 495-2200,
info@palatin.com
Web Site: http://www.palatin.com/
Posted: August 2010
