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8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies Announces Signing of Licensing Agreement with
Fosun Pharma
Rights to Bremelanotide in China and Other Selected
Territories
CRANBURY,
NJ – September 6, 2017 – 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. (NASDAQ: AMAG) 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.
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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.
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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
For more information, contact:
Investors
for Palatin:
Stephen
T. Wills, CPA, MST
Chief
Operating Officer / Chief Financial Officer
609-495-2200
/ info@palatin.com
Media
for Palatin:
Paul
Arndt, MBA, LifeSci Advisors, LLC
Managing
Director
646-597-6992
/ paul@lifesciadvisors.com
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