CRANBURY, N.J., June 21, 2019 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN) announced today that the
U.S. Food and Drug Administration (FDA) has granted marketing
approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA)
for Vyleesi™ (bremelanotide injection), a melanocortin receptor
agonist developed by Palatin indicated for the treatment of
premenopausal women with acquired, generalized hypoactive sexual
desire disorder (HSDD). The FDA's approval of the NDA triggers a
$60 million milestone payment to
Palatin under its North American license agreement with AMAG.
"We are incredibly excited with the FDA's decision to approve
the NDA for Vyleesi as a treatment for premenopausal women with
HSDD," said Carl Spana, Ph.D.,
President and Chief Executive Officer of Palatin. "This FDA
approval means that premenopausal women with HSDD now have a safe
and effective, as-needed treatment option available to them. The
Vyleesi approval is an important milestone for Palatin's employees
and shareholders. It reflects our commitment, ability, and
dedication to the discovery, development and regulatory approval of
novel products with significant unmet medical need and commercial
potential. This FDA approval is a testament to the collaborative
efforts of the Palatin and AMAG teams, and the many patients and
doctors that participated in the Vyleesi clinical trials. I want to
thank everyone for their dedication and commitment that allowed us
to gain approval for this important treatment option for women that
suffer from HSDD."
Vyleesi is the first FDA-approved product for the as needed
treatment of premenopausal women who experience distress or
interpersonal difficulty due to low sexual desire. While the exact
mechanism of action is unknown, Vyleesi is believed to bind to
melanocortin receptors in the central nervous system that are
thought to be associated with sexual function. This new
treatment will be available as a subcutaneous self-injection in a
prefilled disposable autoinjector pen for use in anticipation of a
sexual encounter. AMAG is expected to make Vyleesi commercially
available in September 2019 through
select specialty pharmacies.
Under the terms of the agreement with AMAG, signed in
January 2017, Palatin is entitled to
receive $60 million upon regulatory
approval by the FDA. This payment is expected to be received in
July. Palatin is also entitled to receive tiered royalties on net
sales ranging from high single-digit to low double-digit
percentages. AMAG will also pay Palatin sales milestones based on
escalating annual net sales thresholds, the first of which is
$25 million, triggered at annual net
sales of $250 million.
"I am proud of the determination and passion exhibited by the
Palatin team during the many years it took to develop and
ultimately receive FDA approval of Vyleesi," said Stephen T. Wills, Chief Financial and Operating
Officer of Palatin. "We have already licensed rights to Vyleesi in
North America, China and South
Korea. Now that the FDA has approved Vyleesi, we look
forward to licensing in the remaining regions around the globe. The
$60 million milestone payment
triggered by this FDA approval, coupled with our existing cash,
gives Palatin sufficient funds to significantly advance our
programs for ocular indications such as dry eye, non-infectious
uveitis and other inflammatory indications and for inflammatory
bowel disease indications such as ulcerative colitis for the next
several years."
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD is the most common type of female sexual dysfunction 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
criteria 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 Vyleesi™ (bremelanotide injection)
Vyleesi is approved for the treatment of premenopausal women
with acquired, generalized hypoactive sexual desire disorder
(HSDD). The prefilled Vyleesi autoinjector pen is self-administered
into a woman's abdomen or thigh at least 45 minutes before
anticipated sexual activity and can be taken at any time of day.
Vyleesi is thought to possess a novel mechanism of action. While
the exact mechanism of action is unknown, Vyleesi is believed to
bind to melanocortin receptors in the central nervous system that
are thought to be associated with sexual function.
The most common adverse events were nausea, flushing, injection
site reactions and headache. The majority of events were reported
to be transient and mild-to-moderate in intensity. Vyleesi 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 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, labels and
indications for bremelanotide, whether AMAG will be successful in
marketing bremelanotide in the United
States and potential for licensing of bremelanotide in
additional territories 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.
Vyleesi™ is a trademark of AMAG Pharmaceuticals,
Inc.
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.