CRANBURY, N.J., Nov. 21, 2017 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN; "Palatin") announced today that
it has entered into a collaboration and license agreement with
Kwangdong Pharmaceutical Co., Ltd. ("Kwangdong"), for exclusive
rights to develop and commercialize bremelanotide for female sexual
dysfunction (FSD) indications in the Republic of Korea.
Kwangdong, based in Seoul,
Korea, is a leading Korean pharmaceutical company with
annual sales of approximately $919
million in 2016. A New Drug Application (NDA) is anticipated
to be filed with the U.S. Food and Drug Administration (FDA) in the
first quarter of calendar year 2018.
"We are extremely pleased to have Kwangdong as our partner for
bremelanotide in Korea," stated Carl
Spana, Ph.D., President and CEO of Palatin. "Kwangdong's
significant resources and commercial capabilities are uniquely
suited to raise awareness and understanding of HSDD and the
potential benefits of bremelanotide to health care providers and
patients in Korea. We look forward to working closely with
Kwangdong to assist them in obtaining regulatory approval and have
a successful commercial launch of bremelanotide in Korea."
Sung-Won Choi, President and CEO
of Kwangdong, commented, "We are pleased to partner with Palatin
and further the advancement of the bremelanotide program for the
treatment of female sexual dysfunction in Korea. We believe that
Palatin's bremelanotide, as a niche market product, has tremendous
potential. Our strong marketing and sales capabilities and
established relationships with opinion leaders make us an ideal
partner to introduce bremelanotide, innovative and first-in-class
compounds, to the Korean marketplace."
Under the terms of the agreement, Palatin has granted Kwangdong
an exclusive license to develop and commercialize bremelanotide in
the Republic of Korea for FSD. Kwangdong will be responsible
for all regulatory and other development and clinical activities
necessary for commercialization in the Republic of Korea. In
exchange, Palatin will receive an upfront payment of $500,000 and a $3.0
million milestone based on first commercial sale in Korea.
Palatin has the potential to receive up to $37.5 million in sales related milestones and
mid-single-digit to low double-digit royalties on net sales in the
licensed territory.
Palatin announced in February 2017
that it entered into an agreement with AMAG Pharmaceuticals, Inc.
(NASDAQ: AMAG) granting AMAG exclusive North American rights to
develop and commercialize bremelanotide and in September 2017 announced that it entered into an
agreement with Fosun Pharma granting Fosun exclusive rights to
develop and commercialize bremelanotide in the territories of
mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R. A
New Drug Application (NDA) is anticipated to be filed with the U.S.
Food and Drug Administration (FDA) in the first quarter of calendar
year 2018.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects
approximately 15 million women in the U.S. and is characterized by
low sexual desire that causes marked distress or relationship
anxiety. Approximately 5.8 million pre-menopausal women have a
primary diagnosis of HSDD. Patient awareness and understanding of
the condition remain extremely low, and few women currently seek
treatment. Recent market research indicates that 95 percent of
pre-menopausal women suffering from HSDD are unaware that it is a
treatable medical condition. Furthermore, the majority of these
women indicated a willingness to try a product like bremelanotide,
if recommended by their doctor.
About Bremelanotide
Bremelanotide, an investigational drug product, is thought to
possess a novel mechanism of action, activating endogenous
melanocortin pathways involved in sexual desire and response.
The two Phase 3 studies for HSDD in pre-menopausal women
consisted of double-blind placebo-controlled, randomized parallel
group studies comparing a single use, subcutaneous dose of 1.75 mg
of bremelanotide versus placebo, in each case, delivered via an
auto-injector. Each trial consisted of more than 600 patients
randomized in a 1:1 ratio to either the treatment arm or placebo
with a 24-week evaluation period. In both clinical trials,
bremelanotide met the pre-specified co-primary efficacy endpoints
of median improvement in desire and decrease in distress associated
with low sexual desire as measured using validated patient-reported
outcome instruments.
Women in the trials had the option, after completion of the
trial, to continue in an ongoing open-label safety extension study
for an additional 52 weeks. Nearly 80% of patients who completed
the randomized portion of the study elected to remain in the
open-label portion of the study, and all of these patients will
continue to receive bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent
adverse events were nausea, flushing, and headache, which were
generally mild-to-moderate in severity.
Bremelanotide has no known alcohol interactions.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics 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.
About Kwangdong Pharmaceutical Co., Ltd.
Established in 1963 and headquartered in Seoul, Korea, Kwangdong Pharmaceutical Co.,
Ltd. is a leading Korean-based Pharmaceutical company. The company
reported approximately $919 million
in annual sales in 2016. Kwangdong has more than 500 sales
representatives in Korea. The company has a wide range of business
segments with the aim of improving human health.
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
with bremelanotide, potential actions by regulatory agencies
relating to bremelanotide, potential labels and indications for
bremelanotide, and market potential for bremelanotide 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, regulatory actions by the USPTO, 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.
References Regarding HSDD
U.S Census Bureau, 2014
Shifren et all, Sexual Problems and Distress in United States Women; Obstetrics &
Gynecology, Vol. 112, No. 5, November
2008
U.S. Census Bureau, 2015 American Community Survey 1-Year
Estimates
Mayo Clinic Proceedings: "Hypoactive Sexual Desire
Disorder: International Society for the Study of Women's Sexual
Health (ISSWSH) Expert Consensus Panel Review," Volume 92, Issue 1,
January 2017
Burke Institute: Patient and Economic Flow Study, April 2016
Burke Institute: Patient Segmentation Insights, August 2016
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SOURCE Palatin Technologies, Inc.