CRANBURY, N.J., Jan. 21, 2020 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing targeted, receptor-specific therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, today provided a corporate update and outlook
for calendar year 2020.
"2019 was pivotal for Palatin - we had a major achievement with
the FDA approval of Vyleesi® for the treatment of HSDD
in premenopausal women, which resulted in the receipt of a
$60 million milestone payment," said
Carl Spana, Ph.D., President and
Chief Executive Officer of Palatin. "The FDA approval was also
significant for premenopausal women, as they now have a safe and
effective as-needed treatment option available to them. Our
enhanced cash position, which was $92
million at December 31, 2019,
puts us in an excellent position to advance our pipeline programs.
We have two Phase 2 clinical studies starting in the first half of
calendar year 2020: a dry eye disease study with data expected in
the fourth quarter of calendar year 2020 and an ulcerative colitis
trial with data expected in mid-calendar year 2021."
On January 9, 2020 AMAG
Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a
strategic review, it will divest Vyleesi, which it exclusively
licensed from Palatin for North
America, and another female healthcare product,
Intrarosa®. AMAG stated that it has received preliminary
expressions of interest in these assets.
Under the Vyleesi license agreement, AMAG has a contractual
obligation to use commercially reasonable efforts to commercialize
Vyleesi. If AMAG materially breaches this obligation and fails to
cure such breach, Palatin could potentially have the right to
terminate the license agreement and require AMAG to assign and
transfer its Vyleesi rights to Palatin. In the event AMAG assigns
its Vyleesi license, the assignee must expressly agree to be bound
by the Vyleesi license agreement between AMAG and Palatin.
Dr. Spana further commented, "AMAG's planned divestiture of
Vyleesi is based on its change in strategy and the early commercial
stage of Vyleesi and is not a result of the launch performance to
date. We have a good relationship with AMAG and understand its
decision in the context of its overall strategy. That said, we will
diligently protect our rights as the Vyleesi licensor and take
appropriate steps to safeguard that the significant value of
Vyleesi remains intact and continues to grow. We will also be
opportunistic and flexible as the divestiture process advances,
with the objective that the next owner of the North American rights
to Vylessi is committed to the robust commercialization of the
product."
Overview of Programs and Calendar Year 2020
Outlook
Hypoactive Sexual Desire Disorder (HSDD) /
Vyleesi® (bremelanotide injection)
Vyleesi is the first
as needed treatment approved for premenopausal women with acquired,
generalized HSDD. AMAG Pharmaceuticals, Palatin's North American
licensee, launched Vyleesi nationally in September through select
specialty pharmacies with its established women's health sales
force of approximately 125 sales representatives. While AMAG has
not yet released prescription numbers for the quarter ended
December 31, 2019, AMAG has stated
publicly that the "Vyleesi launch is off to a strong start."
Palatin is advancing discussions on Vyleesi collaborations for
territories outside the currently licensed territories of
North America, China, and Korea, and anticipates executing
multiple agreements during calendar year 2020. Vyleesi is licensed
to Fosun Pharma in China and
Kwangdong Pharmaceuticals in South
Korea. Both companies are advancing Vyleesi through the
regulatory process in their respective territories, which includes
the conduct of certain clinical studies in those territories prior
to filing for market approval.
Anti-Inflammatory / Autoimmune
Programs
Melanocortin agonist products are under
development for the treatment of inflammatory and autoimmune
diseases such as dry eye disease, uveitis, diabetic retinopathy and
inflammatory bowel diseases (ulcerative colitis).
An investigational new drug application (IND) for PL9643 in dry
eye disease (DED) was filed with the US Food and Drug
Administration (FDA) in December
2019. A Phase 2 clinical study is expected to commence in
the first quarter of calendar year 2020, with data readout
anticipated in the fourth quarter of calendar year 2020.
A Phase 2 proof-of-concept clinical study with an oral
formulation of PL8177 in ulcerative colitis patients is anticipated
to commence mid-calendar year 2020, with data readout mid-calendar
year 2021.
Palatin continues its assessment and development work related to
the treatment of patients with diabetic retinopathy and
non-infectious uveitis (NIU) (FDA granted orphan drug designation
for PL8177 in NIU), with the objective of commencing clinical
trials in calendar year 2021.
Natriuretic Peptide Receptor ("NPR") System
Program
Palatin has designed and is developing potential
drug candidates that are selective agonists for one or more
different natriuretic peptide receptors, including natriuretic
peptide receptor-A ("NPR-A"), natriuretic peptide receptor B
("NPR-B"), and natriuretic peptide receptor C ("NPR-C").
PL3994, an NPR-A agonist, will be evaluated in a Phase 2a
clinical study in heart failure patients with preserved ejection
fraction. The proposed study is part of a collaboration with two
major academic medical centers and is supported by an American
Heart Association grant. The study is anticipated to start patient
enrollment in 2020.
PL3994 has potential utility in the treatment of a number of
cardiovascular diseases, including genetic and orphan diseases
resulting from a deficiency of endogenous active NPR-A, and PL5028,
a dual NPR-A and NPR-C agonist in development for cardiovascular
diseases, has potential for reducing cardiac hypertrophy and
fibrosis, among other indications.
Genetic Obesity Program
The Company's
melanocortin receptor 4 ("MC4r") peptide PL8905 and orally active
small molecule PL9610 are currently under investigation for the
treatment of rare genetic metabolic and obesity disorders. These
programs are under internal evaluation for orphan designation,
potential development and licensing.
Corporate
Cash and cash equivalents at
December 31, 2019 amounted to
$92 million. The Company has no
outstanding debt.
About Palatin Technologies
Palatin Technologies, Inc.
is a biopharmaceutical company developing targeted,
receptor-specific 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 clinical trial results, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates,
AMAG's plans to divest Vyleesi and Intrarosa, Palatin's ongoing
relationship with AMAG and ability to protect its rights as the
Vyleesi licensor, and market potential for product candidates, 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, transfer of marketing
and sale of Vyleesi in North
America to another pharmaceutical company, 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.
Vyleesi® is a registered trademark of AMAG
Pharmaceuticals, Inc. in North
America and of Palatin Technologies, Inc. elsewhere in the
world.
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SOURCE Palatin Technologies, Inc.