CRANBURY, N.J., March 26, 2018 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing targeted, receptor-specific peptide therapeutics
for the treatment of diseases with significant unmet medical needs
and commercial potential, announced today that its exclusive North
American licensee for bremelanotide, AMAG Pharmaceuticals, Inc.
(NASDAQ: AMAG), has submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for bremelanotide for the
treatment of hypoactive sexual desire disorder (HSDD) in
premenopausal women. If approved, bremelanotide would become
the first and only as desired pharmacologic option in the U.S.
indicated for the treatment of HSDD in premenopausal women.
"The submission of this NDA represents a significant milestone
for the bremelanotide clinical program and our efforts to develop a
treatment for HSDD," said Carl
Spana, Ph.D., CEO and President of Palatin. "We
believe our licensing agreement with AMAG for bremelanotide has the
potential to create significant long-term shareholder value and are
proud of the work conducted by both Palatin and AMAG to prepare and
submit this NDA. Importantly, we have additional licensees
for bremelanotide in South Korea
and China, and look forward to
entering into similar agreements in other countries and
regions."
Palatin expects that within 60 days the FDA will determine
whether the NDA is complete for filing. If the NDA is
accepted, the FDA will assign a Prescription Drug User Fee Act
(PDUFA) target action date by which it intends to complete its
review.
Palatin previously announced positive results for two Phase 3
trials of bremelanotide for the treatment of HSDD in premenopausal
women that met the pre-specified co-primary efficacy
endpoints. Palatin's license agreement with AMAG
Pharmaceuticals, Inc. grants AMAG exclusive North American rights
to develop and commercialize bremelanotide. Under the terms
of the agreement, Palatin will receive up to $80 million contingent upon achieving certain
regulatory milestones, including acceptance of the NDA by the FDA,
and up to $300 million contingent
upon meeting certain sales milestones. Palatin is also entitled
to receive tiered royalties on net sales ranging from high
single-digit to low double-digit percentages.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects
approximately 12 million women in the U.S. The condition is
characterized by low sexual desire and marked distress which are
not attributable to existing medical, pharmacologic, psychiatric,
or relationship issues.i Approximately 6 million
pre-menopausal women meet the diagnosis for acquired, generalized
HSDD.ii Patient awareness and understanding of the
condition remains low, and few women currently seek or receive
treatment. Recent industry-sponsored market research indicates that
up to 95 percent of premenopausal women suffering from HSDD are
unaware that it is a treatable medical condition.iii
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 Phase 3 RECONNECT studies for HSDD in premenopausal women
consisted of two double-blind placebo-controlled, randomized
parallel group studies comparing the as desired use of 1.75 mg of
bremelanotide versus placebo, in each case, delivered via a
subcutaneous 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 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.
In the Phase 3 clinical trials, the most frequent adverse events
were nausea, flushing, and headache, which were generally
mild-to-moderate in intensity and were transient.
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 NDA will be accepted for filing by FDA,
whether FDA will provide regulatory approval for bremelanotide,
whether AMAG will be successful in developing and commercializing
bremelanotide in the United
States, 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, 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
i Shifren et al, Sexual Problems and Distress in
United States
Women; Obstetrics & Gynecology, Vol. 112, No. 5,
November 2008; 2014 U.S. Census
data
ii Patient & Economic Flow Study sponsored by
Palatin Technologies, Inc. and conducted by Burke Institute,
April 2016
iii Patient & Economic Flow Study sponsored by
Palatin Technologies, Inc. and conducted by Burke Institute,
April 2016
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SOURCE Palatin Technologies, Inc.