CRANBURY, NJ, Sept. 6, 2017 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN; "Palatin") announced today that
it has entered into a collaboration and license agreement with
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
("Fosun Pharma"), for exclusive rights to develop and commercialize
bremelanotide for female sexual dysfunction (FSD) indications in
the territories of mainland China,
Taiwan, Hong Kong S.A.R. and Macau
S.A.R. Fosun Pharma is a leading Chinese healthcare provider
with annual sales of more than $2
billion. Bremelanotide is an investigational product
designed for on-demand treatment of hypoactive sexual desire
disorder (HSDD) in premenopausal women. Palatin previously
announced positive Phase 3 results with bremelanotide for treating
HSDD in premenopausal women. 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.
Under the terms of the agreement, Palatin will receive an
upfront payment of $5.0 million and a
$7.5 million milestone based on
regulatory approval in China.
Palatin has the potential to receive up to $92.5 million in sales related milestones and
high single-digit to low double-digit royalties on net sales in the
licensed territory. All development, regulatory, sales, marketing,
and commercial activities and associated costs in the licensed
territory will be the sole responsibility of Fosun Pharma.
"We are extremely pleased to have Fosun Pharma as our partner
for bremelanotide in mainland China and certain surrounding territories,"
stated Carl Spana, Ph.D., President
and CEO of Palatin. "Fosun'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. I am confident that Fosun
will drive a successful approval and launch of bremelanotide in
China. This collaboration is
aligned with Palatin's global strategy to bring bremelanotide to
the market for the millions of women who have female sexual
dysfunction and are seeking a safe and effective treatment."
Yifang Wu, Chief Executive
Officer of Fosun Pharma, commented, "We are pleased to partner with
Palatin and further the advancement of the bremelanotide program
for the treatment of female sexual dysfunction in China. Female Healthcare is an important area
of our growth strategy. Bremelanotide complements our active
strategy to bring innovative and first-in-class compounds to market
and we look forward to advancing bremelanotide to address the
large, unmet medical needs of women with female sexual
dysfunction."
Palatin previously announced that it entered into an agreement
with AMAG Pharmaceuticals, Inc. granting AMAG exclusive North
American rights to develop and commercialize bremelanotide.
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 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co.,
Ltd. ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a leading
healthcare group in China. Fosun
Pharma's business covers the whole healthcare industry chain,
including pharmaceutical manufacturing and R&D, healthcare
services, medical devices and diagnosis, as well as pharmaceutical
distribution and retail, making contribution to improving people's
health. Fosun Pharma maintains a national recognized enterprise
technology center and a highly capable international R&D team,
with relentless efforts exerted on innovation and research of
therapeutic areas including cardiovascular system, central nervous
system, blood system, metabolism and alimentary system,
anti-infection and anti-tumor. Going forward, Fosun Pharma will
adhere to the brand philosophy of "Innovation for Good Health", and
will continue sticking to the development strategy of "organic
growth, external expansion and integrated development", striving to
become a first-tier enterprise in the global mainstream
pharmaceutical and healthcare market.
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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