Full Press Release Details
FDA Approves New Drug Application for Vyleesi (bremelanotide
First FDA-Approved As-Needed Treatment for Acquired, Generalized
Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal
NDA Approval Triggers $60 Million Milestone Payment to
N.J., June 21, 2019 -- 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
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
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
the terms of the agreement with AMAG, signed in January 2017,
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.
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)
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
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
Forward-looking 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