CRANBURY, N.J., Sept. 21, 2015 /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 need and
commercial potential, today announced that the Company and
Gedeon Richter (Richter) mutually
and amicably agreed to terminate the license and collaboration
agreement for bremelanotide for the treatment of female sexual
dysfunction (FSD). All rights and licenses granted to Richter have
terminated and reverted back to Palatin. There are no payment or
reimbursement obligations as a result of the license agreement
termination.
Palatin entered into the license agreement with Richter in
August 2014 to co-develop and
commercialize bremelanotide for FSD in the European Union, other
European countries and additional selected countries. Palatin
received €7.5 million ($9.8 million)
in total upfront payments from Richter, and a milestone payment of
€2.5 million ($3.1 million) upon the
initiation of its Phase 3 clinical trial program in the United States.
Palatin now has the global rights to bremelanotide for FSD,
providing the Company and its business development efforts with
additional options and flexibility. Palatin is actively engaged in
licensing and collaboration discussions with multiple companies for
both global and regional commercial rights to bremelanotide.
Bremelanotide development overview for the treatment of FSD:
- Palatin initiated Protocols 301 and 302 of its Phase 3
reconnect study in the United
States and Canada for the
treatment of FSD in December 2014 and
January 2015, respectively. Further
information on the trial protocols can be found at
clinicaltrials.gov.
- The two Phase 3 studies are progressing as planned and meeting
target objectives.
- Enrollment is greater than 50% to date and is expected to be
completed in the fourth quarter of calendar year 2015.
- Top-line data is expected to be available in the third quarter
of calendar year 2016.
- The clinical trials are designed to randomize approximately
1,100 women (~550 per trial) to evaluate the efficacy and safety of
subcutaneous bremelanotide in premenopausal women with hypoactive
sexual desire disorder as an on-demand, as-needed treatment. For
further information, visit reconnectstudy.com.
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).
Bremelanotide is an on-demand, as-needed treatment and has the
potential to transform the treatment of patients with FSD.
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]
About Palatin Technologies, Inc.
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.
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, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, business development and licensing programs,
proposed indications for product candidates and market potential
for product candidates, 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 clinical
trials, regulatory actions by the FDA 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, entering into marketing and
distribution agreements, 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.