Full Press Release Details
Palatin Technologies, Inc. Reports Second Quarter
Fiscal Year 2020 Financial Results and Recent Business
Phase 2 Study to Commence Q1 2020 Data Q4 2020
Million in Cash and Cash Equivalents at December
AMAG Announced Plans to Divest
for Premenopausal Women
Sexual Desire Disorder (HSDD)
and Webcast to be held on February 11, 2020
CRANBURY, NJ February 11, 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, whose product candidates are
targeted, receptor-specific therapeutics for the treatment of
diseases with significant unmet medical need and commercial
potential, today announced results for its second quarter ended
The June 2019 FDA approval of Vyleesi
was meaningful on two fronts,
said Carl Spana, Ph.D., President and Chief Executive Officer of
Palatin. For premenopausal women, it provides a safe and
effective, as-needed treatment option for those with HSDD. For
Palatin, we now have an enhanced cash position of $92 million at
December 31, 2019, which 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.
AMAG's planned divestiture of Vyleesi is based on its
change in strategy, and is not a result of the Vyleesi launch
performance to date, continued Spana. As the
licensor, we maintain certain rights and will take appropriate
steps to ensure that the value of Vyleesi remains intact and
continues to grow. We will also continue to be opportunistic and
flexible as the divestiture process advances, with the objective
that the ultimate licensee of the North American rights to Vylessi
is committed to the robust commercialization of the
Recent Business Highlights
Desire Disorder (HSDD) / Vyleesi (bremelanotide
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,
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 have Vyleesi returned 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.
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
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 2019 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.
Anti-Inflammatory / Autoimmune Programs
Melanocortin agonist products are under development for the
treatment of inflammatory and autoimmune diseases such as dry eye,
uveitis, diabetic retinopathy and inflammatory bowel diseases
(ulcerative colitis).
An investigational new drug application (IND) for PL9643 in dry eye
disease 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
A Phase 2 proof-of-concept clinical study with an oral formulation
of PL8177 in ulcerative colitis patients is anticipated to start
mid-calendar year 2020, with data readout mid-calendar year
Palatin continues its assessment and development work related to
the treatment of patients with diabetic retinopathy and
non-infectious uveitis (NIU), an indication which FDA granted
orphan drug designation, 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 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
PL3994 has potential utility in the treatment of a number of