CRANBURY, N.J., July 27, 2020 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a specialized
biopharmaceutical company developing first-in-class medicines based
on molecules that modulate the activity of the melanocortin and
natriuretic peptide receptor systems, today announced that it has
mutually terminated the January 2017 license agreement
which granted AMAG Pharmaceuticals ("AMAG") exclusive North
American rights to market Vyleesi® (bremelanotide), the first and
only on demand treatment for pre-menopausal women suffering from
acquired, generalized, hypoactive sexual desire disorder (HSDD), a
condition affecting one in ten premenopausal women.
Under the terms of the termination agreement, Palatin will
regain all North American development and commercialization rights
for Vyleesi. AMAG will make a $12
million payment to Palatin at closing and a $4.3 million payment to Palatin on March 31, 2021. Palatin will assume all Vyleesi
manufacturing agreements, and AMAG will transfer all information,
data, and assets related exclusively to Vyleesi, including, but not
limited to, existing inventory. AMAG will provide certain
transitional services to Palatin for a period of time to ensure
continued patient access to Vyleesi during the transition back to
Palatin. Palatin will reimburse AMAG for the costs of the
transition services.
"We continue to believe that Vyleesi is an important treatment
option for the millions of premenopausal women suffering from HSDD
and are pleased that our termination and transfer agreement with
AMAG ensures no disruption for patient access to Vyleesi,"
stated Carl Spana, Ph.D., President and CEO of Palatin.
"Having full ownership of an FDA approved product provides us with
the ability to capitalize on a broad range of strategic
opportunities, including the re-licensing of Vyleesi to a partner
that is committed to women's health."
"As a clinician who treats women who suffer from HSDD, a medical
condition which extends well beyond the bedroom and that can
significantly impact self-esteem, body image, and intimate
relationships, I am pleased that Palatin is dedicated to the
continued affordable access and commercialization of Vyleesi, a
treatment option that can be delivered on an as-needed basis," said
Sheryl Kingsberg, Ph.D., Division Chief of Behavioral
Medicine, University Hospitals Cleveland Medical Center."
Palatin is exploring strategic options with the goal of
enhancing the commercialization of Vyleesi, including but not
limited to, discussions with companies that currently market female
healthcare products for potential collaborations. In the interim,
the Company's go forward strategy is to implement an informed and
highly targeted approach for marketing, utilizing telemedicine,
social media, and digital advertising. The Company is committed to
working with payers and healthcare professionals to ensure women
with HSDD have continued and affordable access to Vyleesi. Vyleesi
remains commercially available through specialty pharmacies, Avella
and BioPlus, with patients also having the ability to connect with
a physician through a telemedicine option. Patients and healthcare
providers can learn more about HSDD and Vyleesi
at www.vyleesi.com.
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. This
treatment is available as a subcutaneous self-injection in a
prefilled disposable autoinjector pen for use in anticipation of a
sexual encounter.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on
July 27, 2020 at 8:30 a.m. Eastern Time to discuss its Vyleesi
program in greater detail. Individuals interested in
listening to the conference call live can dial 1-800-700-1722
(US/Canada) or 1-334-323-0509
(international), conference ID 9136500. The audio webcast and
replay can be accessed by logging on to the "Investor/Webcasts"
section of Palatin's website at http://www.palatin.com. A
telephone and audio webcast replay will be available approximately
one hour after the completion of the call. To access the
telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international),
passcode 9136500 The webcast and telephone replay will be
available through August 3, 2020.
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.
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.i Approximately 6 million pre-menopausal
women meet the diagnosis criteria for acquired, generalized
HSDD.ii Patient awareness and understanding of the
condition remains low, and few women currently seek or receive
treatment. 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 Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized biopharmaceutical
company developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin and natriuretic peptide
receptor systems, with targeted, receptor-specific product
candidates 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 commercial strategies
and efforts, including regaining all North American development and
commercialization rights for Vyleesi, estimates and beliefs
regarding the market opportunities for Vyleesi, transitional
services for Vyleesi to be provided by AMAG, clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates, market potential for product candidates,
and potential adverse impacts due to the global COVID-19 pandemic
such as delays in regulatory review, manufacturing and supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy, 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, Palatin's ability to
market and commercialize Vyleesi in the
United States, sales of Vyleesi in the United States and elsewhere in the world,
results of clinical trials, regulatory actions by the FDA and other
regulatory 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.
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.