CRANBURY, N.J., June 4, 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 the U.S. Food and
Drug Administration (FDA) has accepted the bremelanotide New Drug
Application (NDA) for filing. The NDA was filed on
March 23, 2018 by AMAG
Pharmaceuticals, the Company's exclusive North American
licensee. Bremelanotide, an investigational melanocortin
agonist, is being developed for the treatment of hypoactive sexual
desire disorder (HSDD) in premenopausal women.
The PDUFA (Prescription Drug User Fee Act) goal date for
completion of the FDA review of the bremelanotide NDA is
March 23, 2019. 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 FDA's acceptance of the NDA triggers a $20 million milestone payment to Palatin under
its license agreement with AMAG Pharmaceuticals, less agreed upon
deductions for expenses incurred by AMAG. Under the terms of the
agreement, signed in January 2017,
Palatin is entitled to receive up to $80
million contingent upon achieving certain regulatory
milestones, consisting of $20 million
upon the acceptance of the NDA filing by the FDA and up to
$60 million upon regulatory approval
by the FDA. Palatin is also entitled to receive tiered
royalties on net sales ranging from high single-digit to low
double-digit percentages and up to $300
million contingent upon meeting certain sales
milestones.
"We are very pleased with the FDA's acceptance of the NDA filing
for bremelanotide," said Carl Spana,
Ph.D., CEO and President of Palatin. "This is an important
milestone for Palatin and reflects our drive and commitment to the
development of novel therapies to treat conditions with significant
unmet medical need and commercial potential. We look forward to
assisting AMAG during the FDA review process. HSDD is an
underserved medical condition and, if approved, bremelanotide has
significant potential as an as-desired treatment of HSDD in
premenopausal women."
In its acceptance letter, the FDA stated that it is currently
planning to hold an advisory committee meeting to discuss this
application. The Company will announce the date of the
Advisory Committee meeting when it is scheduled.
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.
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.1 Approximately 6 million
pre-menopausal women meet the diagnosis for acquired, generalized
HSDD.2 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.3
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 and conditions 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 potential actions by
regulatory agencies relating to bremelanotide, potential labels and
indications for bremelanotide, 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.
1 Shifren et al, Sexual Problems and Distress in
United States
Women; Obstetrics & Gynecology, Vol. 112, No. 5,
November 2008; 2014 U.S. Census
data
2 Patient & Economic Flow Study sponsored by Palatin
Technologies, Inc. and conducted by Burke Institute, April 2016
3 Patient & Economic Flow Study sponsored by Palatin
Technologies, Inc. and conducted by Burke Institute, April 2016
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SOURCE Palatin Technologies, Inc.