Full Press Release Details
Palatin Technologies Announces Mutual Termination of License
Agreement with AMAG Pharmaceuticals for Vyleesi
Palatin Regains All Rights
Company to Receive $16.3 Million from AMAG
Teleconference and Webcast to be held on July 27, 2020
CRANBURY, NJ July 27, 2020 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
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,
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
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
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
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
About Vyleesi (bremelanotide injection)
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.
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)
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. 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