Full Press Release Details
Palatin Technologies Announces Signing of Licensing Agreement with
Rights to Bremelanotide in China and Other Selected
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
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
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.
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
previously announced that it entered into an agreement with AMAG
Pharmaceuticals, Inc. (NASDAQ: AMAG) granting AMAG exclusive North
American rights to develop and commercialize
About Hypoactive Sexual Desire Disorder (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.
an investigational drug product, is thought to possess a novel
mechanism of action, activating endogenous melanocortin pathways
involved in sexual desire and response.
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.
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.
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.
has no known alcohol interactions.
About Palatin Technologies
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.
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