CRANBURY, N.J. and BUDAPEST, Hungary, Sept. 3, 2014 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN; hereinafter: "Palatin") and
Gedeon Richter Plc. (hereinafter: "Richter") announced that they
have entered into a collaboration and license agreement to
co-develop and commercialize bremelanotide for female sexual
dysfunction (FSD) indications in the European Union, other European
countries and additional selected countries. Richter is a
European-based specialty pharmaceutical company with a strong focus
in female health and annual sales of more than €1.2 billion
($1.6 billion).
Under the terms of the agreement, Palatin will receive total
upfront payments of €7.5 million ($9.9
million). Palatin and Richter will each contribute to the
European co-development activities (primarily one phase 3 clinical
trial in Europe) for obtaining
regulatory approval in Europe.
Palatin anticipates that its part of the European co-development
activities will be cash neutral through the European regulatory
filing stage. All sales, marketing, and commercial activities and
associated costs in the licensed territory will be the sole
responsibility of Richter.
Palatin will additionally receive €2.5 million ($3.3 million) upon initiation of its phase 3
clinical trial program in the United
States. Palatin is also eligible to receive €20 million
($26.4 million) regulatory related
milestones. Palatin has the potential to receive up to €60 million
($79.2 million) potential sales
related milestones and low double-digit royalties on net sales in
the licensed territory.
"We are extremely pleased to have Richter as our European
partner for bremelanotide. They are a leader in the
development and marketing of female healthcare products. Their
female healthcare franchise had over $500
million in sales in 2013 and they have a strong and growing
presence in Europe and other
regions," stated Carl Spana, Ph.D.,
President and CEO of Palatin. "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." Dr. Spana further
stated that, "In addition, we are focused on starting the
bremelanotide phase 3 clinical trials in the U.S. in the fourth
quarter of 2014 and on furthering discussions for partnerships for
the U.S. and other territories."
Erik Bogsch, Chief Executive
Officer of Richter, commented, "We are pleased to partner with
Palatin and assist in the advancement of the bremelanotide program
for the treatment of female sexual dysfunction. Female Healthcare
is an important area of our strategy and is growing nicely. We are
committed to development activities to treat conditions in women
that have a severe impact on the patient's quality of life.
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."
About Bremelanotide for Female Sexual Dysfunction
Palatin is developing bremelanotide subcutaneous for the
treatment of FSD in premenopausal women diagnosed with FSD.
Bremelanotide, which is a melanocortin agonist (a compound which
binds to a cell receptor and triggers a response) drug candidate,
is a synthetic peptide analog of the naturally occurring hormone
alpha-MSH (melanocyte-stimulating hormone).
About Female Sexual Dysfunction
Female Sexual Dysfunction covers multi-factorial conditions that
have anatomical, physiological, medical, psychological and social
components. We will seek approval of bremelanotide for the largest
category of FSD, hypoactive sexual desire disorder. To establish a
diagnosis of FSD, one or more of the disorders making up FSD must
be associated with personal distress, as determined by the affected
women.i A study of more than 30,000 U.S. women in 2008
reported an age-adjusted point prevalence of sexual difficulties
causing personal distress in 12 percent of
respondents.ii
There are no drugs in the United
States approved for the treatment of FSD. Bremelanotide is
an on-demand treatment and has the potential to transform the
treatment of patients with FSD.
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
http://www.palatin.com.
About Gedeon Richter
Gedeon Richter (www.richter.hu),
headquartered in Budapest/Hungary,
is a major pharmaceutical company in Central Eastern Europe, with
an expanding direct presence in Western
Europe. Richter's consolidated sales were approximately
EUR 1.2 billion (USD 1.6 billion) while its market capitalization
amounted to EUR 2.8 billion
(USD 3.8 billion) in 2013. The
product portfolio of Richter covers almost all important
therapeutic areas, including gynaecology, central nervous system,
and cardiovascular areas. Having the largest R&D unit in
Central Eastern Europe, Richter's original research activity
focuses on CNS disorders. With its widely acknowledged steroid
chemistry expertise, Richter is a significant player in the female
healthcare field worldwide. Richter is also active in biosimilar
product development.
For more information about Gedeon
Richter:
Investors: Katalin Ordog +36 1
431 5680
Media: Zsuzsa Beke +36 1 431
4888
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 the prospects of
entering into one or more license agreements in European countries
or other regions relating to bremelanotide, potential clinical
trial results with bremelanotide, potential actions by regulatory
agencies in the United States or
Europe relating to bremelanotide,
regulatory plans, clinical trial expectations and results,
development programs and the market potential of 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, the ability of Palatin
to enter into one or more agreements relating to the
commercialization of bremelanotide, results of nonclinical,
preclinical and toxicology studies, result of clinical trials,
regulatory actions by the FDA and other regulatory agencies and the
need for regulatory approvals, 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.
i Frank J et al. Diagnosis and Treatment of
Female Sexual Dysfunction. AmFam Physician 2008; 77(5):
635-642.
ii Shifren JL et al. Sexual Problems and
Distress in United States Women:
Prevalence and Correlates. ObstetGynecol 2008;112 (5);
968-9.
SOURCE Palatin Technologies, Inc.