CRANBURY, N.J., Dec. 29, 2014 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical needs and
commercial potential, today announced that it has started its
bremelanotide pivotal registration program. The Company has
initiated its phase 3 reconnect study in the United States for the treatment of female
sexual dysfunction (FSD).
"We are pleased to achieve this major milestone in the
bremelanotide program with the initiation of our phase 3
reconnect study in the U.S," stated Carl Spana, Ph.D., President and CEO of
Palatin. "This is a key step in our global strategy to bring
bremelanotide to market for the millions of women who have FSD and
are seeking a safe and effective treatment." Dr. Spana
further stated that, "Our recent $30
million financing has provided the financial resources to
start the bremelanotide phase 3 pivotal registration program and
timing flexibility regarding partnering for the U.S. and other
non-European territories."
The start of the reconnect study phase 3 clinical trial
in the U.S triggers a development milestone payment of €2.5 million
(~$3 million) from Gedeon Richter
Plc, Palatin's partner in Europe
for bremelanotide for FSD. Palatin is also eligible to
receive regulatory and sales milestones, and low double-digit
royalties on net sales in the European licensed territory.
Protocol 301 of the reconnect study is a
multicenter (~80 sites), randomized, placebo controlled,
parallel-group, eight month trial with an open-label extension
phase. It is designed to randomize approximately 550 women in
North America to evaluate the
efficacy and safety of subcutaneous bremelanotide in premenopausal
women with hypoactive sexual desire disorder (HSDD) as an
on-demand, as-needed treatment. Initial data from the study
is anticipated in the middle of calendar year 2016. More
information on the trial protocol, including trial design,
inclusion/exclusion criteria, etc., can be found at
http://clinicaltrials.gov.
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, as-needed 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.
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, 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.
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SOURCE Palatin Technologies, Inc.