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.