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| 8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
| EX-10.1 - TERMINATION AGREEMENT - PALATIN TECHNOLOGIES INC | ptn_ex101.htm |
Exhibit 99.1
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
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.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
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.
_____________________________
-More-
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.
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Investor Inquiries:
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Media Inquiries:
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Stephen T. Wills, CPA, MST
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Paul Arndt, MBA,
LifeSci Advisors
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CFO/COO (609) 495-2200
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Managing
Director (646) 597-6992
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Info@Palatin.com
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Paul@LifeSciAdvisors.com
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