CRANBURY, N.J., July 1, 2019 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE American: PTN), a biopharmaceutical
company developing targeted, receptor-specific peptide therapeutics
for the treatment of diseases with significant unmet medical need
and commercial potential, today provided a mid-calendar year update
on its corporate and clinical development programs.
"We accomplished our primary objectives of procuring FDA
approval of Vyleesi and advancing our pipeline programs," said
Carl Spana, Ph.D., President and
Chief Executive Officer of Palatin. "The FDA approval is an
incredible achievement for Palatin, and we are excited that
premenopausal women now have a safe and effective, as-needed
treatment option available to them for the treatment of HSDD. Our
estimated pro forma cash at June 30,
2019 of $102 million is
sufficient to cover planned operations through at least calendar
year 2021. We are focused on executing Vyleesi collaborations
for territories outside the currently licensed territories of
North America, China, and Korea, and initiating multiple
Phase 2 trials over the next several quarters for the treatment of
non-infectious uveitis, ulcerative colitis and dry eye
disease."
Program and Operational Updates for the Six Months Ended
June 30, 2019
Female Sexual Dysfunction /
Vyleesi™(bremelanotide)
The U.S. Food and Drug
Administration (FDA) 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 on June 21, 2019 triggered a $60 million milestone payment to Palatin under
its North American license agreement with AMAG. 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 pharmacies.
Anti-Inflammatory / Autoimmune
Programs
Melanocortin Agonists under development for the
treatment of inflammatory and autoimmune diseases such as dry eye,
uveitis, diabetic retinopathy and inflammatory bowel diseases
(ulcerative colitis).
PL-8177, a selective MC1r peptide agonist announced positive
results of a micro-dose study of radiolabeled PL-8177 using an
oral, delayed-release, polymer formulation. The study met all
primary and secondary endpoints. PL-8177 is a patented
melanocortin receptor 1 agonist with potential application in
treatment of ulcerative colitis and other inflammatory bowel
diseases. The FDA granted orphan drug designation for PL-8177
for the treatment of non-infectious intermediate, posterior, pan
and chronic anterior uveitis. Non-infectious uveitis (NIU) is a
group of inflammatory diseases that produces swelling and destroys
eye tissue and can result in vision loss. A phase 2
proof-of-concept clinical study with a systemic formulation in NIU
patients is anticipated to commence in the fourth quarter of
calendar year 2019. A phase 2 proof-of-concept clinical study
with an oral formulation in ulcerative colitis patients is
anticipated to commence in the first quarter of calendar year
2020.
An IND application for PL-9643, a melanocortin peptide agonist,
and a Phase 2 clinical study in dry eye disease is currently
anticipated to commence in the first half of calendar year
2020.
Natriuretic Peptide Receptor ("NPR") System
Program
The Company has designed and is developing
potential drug candidates that are selective agonist 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").
Active collaborations with several institutions are ongoing for
PL-3994, an NPR-A agonist that 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 PL-5028, a dual NPR-A and NPR-C agonist in
development for cardiovascular diseases, including reducing cardiac
hypertrophy and fibrosis. A phase 2A clinical trial evaluating
PL-3994 in heart failure patients with preserved left ventricular
ejection fraction will begin enrollment in the second half of
calendar year 2019. This trial is supported by a grant from the
American Heart Association.
Genetic Obesity Program
A program for the
Company's Melanocortin receptor 4 ("MC4r") peptide PL-8905, and
orally-active small molecule PL-9610, are currently under
investigation for the treatment of rare genetic metabolic and
obesity disorders. These programs are under internal
evaluation for orphan designation, and an IND filing and the
initiation of a Phase 1 study are targeted for the first half of
2020.
Corporate
Debt and related liabilities
decreased from $7.2 million at
June 30, 2018 to $0.8 million at June 30,
2019, with final payment due July
2019.
The Company has a $40 million
at-the-market offering available for financing flexibility, and it
may from time to time, opportunistically, sell shares at prices it
believes are advantageous to the Company and its
shareholders. The Company has, to date, sold $10.6 million of the available $40 million at-the-market offering.
Cash and cash equivalents at June 30,
2019, on a pro forma basis, which includes the $60 million milestone payment payable by
exclusive North American licensee, AMAG Pharmaceuticals, Inc.,
within 30 days of FDA approval of Vyleesi, is estimated to be
$102 million dollars. The
Company believes the $102 million is
sufficient to fund planned operations through at least calendar
year 2021, including the initiation of Phase 2 clinical trials for
its ocular program for non-infectious uveitis and its ulcerative
colitis program by calendar year end 2019. The Company also intends
to complete preclinical development activities and file an IND
application for ocular inflammation indications, including dry eye,
and commence clinical trials in the first half of calendar year
2020.
About Palatin Technologies
Palatin 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
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 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 bremelanotide in additional territories 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, results of nonclinical, preclinical
and toxicology studies, result of clinical trials, regulatory
actions by the FDA 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.
VyleesiTM is a trademark of AMAG Pharmaceuticals,
Inc.
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SOURCE Palatin Technologies, Inc.