CRANBURY, N.J., March 20, 2017 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, announced today that the United States Patent
and Trademark Office (USPTO) has issued a Notice of Allowance for
U.S. Patent Application Serial Number 14/704,223. The allowed
claims are for methods of treating female sexual dysfunction and
hypoactive sexual desire disorder (HSDD) with bremelanotide, an
investigational product designed for on-demand treatment of HSDD in
premenopausal women. Once issued, the patent will have a term to
November 2033.
Stephen T. Wills, Chief Operating
Officer and Chief Financial Officer of Palatin, commented, "We are
pleased to have received a notice of allowance from the USPTO,
which signifies that a patent can be granted from an application.
We believe that this patent, with a term out to 2033, further
strengthens the intellectual property portfolio for the
bremelanotide development program."
Palatin previously announced positive Phase 3 results with
bremelanotide for treating HSDD in premenopausal women. Palatin has
entered into an agreement with AMAG Pharmaceuticals, Inc. (Nasdaq:
AMAG) granting AMAG exclusive North American rights to develop and
commercialize bremelanotide.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects
approximately 15 million women in the U.S. and is characterized by
low sexual desire that causes marked distress or relationship
anxiety. Approximately 5.8 million pre-menopausal women have a
primary diagnosis of HSDD. Patient awareness and understanding of
the condition remain extremely low, and few women currently seek
treatment. Recent market research indicates that 95 percent of
pre-menopausal women suffering from HSDD are unaware that it is a
treatable medical condition. Furthermore, the majority of these
women indicated a willingness to try a product like bremelanotide,
if recommended by their doctor.
About Bremelanotide
Bremelanotide, an investigational product, is thought to possess
a novel mechanism of action, activating endogenous melanocortin
pathways involved in sexual desire and response.
The two Phase 3 studies for HSDD in pre-menopausal women
consisted of double-blind placebo-controlled, randomized parallel
group studies comparing a single use, subcutaneous dose of 1.75 mg
of bremelanotide versus placebo, in each case, delivered via an
auto-injector. Each trial consisted of more than 600 patients
randomized in a 1:1 ratio to either the treatment arm or placebo
with a 24 week evaluation period. In both clinical trials,
bremelanotide met the pre-specified co-primary efficacy endpoints
of median improvement in desire and decrease in distress associated
with low sexual desire as measured using validated patient-reported
outcome instruments.
Women in the trials had the option, after completion of the
trial, to continue in an ongoing open-label safety extension study
for an additional 52 weeks. Nearly 80% of patients who completed
the randomized portion of the study elected to remain in the
open-label portion of the study, and all of these patients will
continue to receive bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent
adverse events were nausea, flushing, and headache, which were
generally mild-to-moderate in severity.
Bremelanotide has no known alcohol interactions.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential. 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's 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 clinical trial results
with bremelanotide, potential actions by regulatory agencies
relating to bremelanotide, potential labels and indications for
bremelanotide, whether the subject patent will issue or adequately
protect against competition, the future status of pending and
planned patent applications, 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 nonclinical,
preclinical and toxicology studies, result of clinical trials,
regulatory actions by the FDA and the need for regulatory
approvals, regulatory actions by the USPTO, 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.
References Regarding HSDD
U.S Census Bureau, 2014
Shifren et all, Sexual Problems and Distress in United States Women; Obstetrics &
Gynecology, Vol. 112, No. 5, November
2008
U.S. Census Bureau, 2015 American Community Survey 1-Year
Estimates
Mayo Clinic Proceedings: "Hypoactive Sexual Desire
Disorder: International Society for the Study of Women's Sexual
Health (ISSWSH) Expert Consensus Panel Review," Volume 92, Issue 1,
January 2017
Burke Institute: Patient and Economic Flow Study, April 2016
Burke Institute: Patient Segmentation Insights, August 2016
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SOURCE Palatin Technologies, Inc.