Palatin Technologies Supports FDA's Approval of the First-Ever Treatment for Female Sexual Dysfunction

Aug 18, 2015, 20:13 ET from Palatin Technologies, Inc.

CRANBURY, N.J., Aug. 18, 2015 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential. Palatin's lead product under development is bremelanotide for the treatment of female sexual dysfunction (FSD).

The approval of flibanserin (under development by Sprout Pharmaceuticals) today by the U.S. Food and Drug Administration (FDA) marks a long-awaited milestone in healthcare for women.  The FDA's approval of flibanserin validates that there is an important need for women living with hypoactive sexual desire disorder, or HSDD, to have an approved treatment option. Palatin applauds the FDA's positive determination, which supports FDA's previous statements that HSDD is an unmet medical need requiring a safe treatment option for women with HSDD. 

HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity, which causes a woman distress or puts a strain on the relationship with her partner, and cannot be accounted for by another medical, physical or psychiatric condition, or as a result of other medication. It is estimated that one in 10 women may have the signs of HSDD at some point in their life, and as such HSDD represents a major opportunity to address a tremendous medical need with therapies like flibanserin and bremelanotide.

Palatin Technologies is continuing the development of bremelanotide, a first-in-class, as needed, melanocortin-4 receptor agonist being studied for the treatment of HSDD in pre-menopausal women, so that these women suffering from HSDD have multiple treatment options in the future. Bremelanotide has a novel mechanism that activates endogenous pathways in the brain involved in creating a sexual response. Unlike flibanserin or certain other FSD treatments in development that require daily administration, bremelanotide is an as-needed (not chronic), centrally-mediated medication. Studies have shown that bremelanotide starts working within 30 to 60 minutes of administration and remains effective for approximately eight hours, providing women with greater control and flexibility in their treatment as well as a quick response. By comparison, flibanserin must be taken daily and may take up to several weeks of continuous daily use before an effect of increased sexual desire is seen. The differing dose frequency and route of administration, if available in the marketplace at the same time, could provide a robust set of treatment options for women suffering from HSDD.

Palatin Technologies is excited to continue working toward bringing bremelanotide as a treatment for HSDD closer to a reality, expanding the HSDD marketplace and providing women with multiple options.  Palatin Technologies is currently enrolling pre-menopausal women with HSDD into its Phase III trials for bremelanotide, and anticipates completing enrollment for the trials by the end of this year. Each pivotal trial of the reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1100 women (~550 each trial) 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. More information on the trial protocol, including trial design and inclusion/exclusion criteria, 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

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.

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 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.



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